Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft (AVeNEW)

• ClinicalTrials.gov Identifier: NCT02649946
• Recruitment Status: Completed
• First Posted: January 8, 2016
• Results First Posted: May 13, 2019
• Last Update Posted: December 21, 2021
• Sponsor: C. R. Bard
• Information provided by (Responsible Party): C. R. Bard

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Stenosis; Restenosis
• Interventions: Device: Covera Vascular Covered Stent following PTA; Procedure: Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon
• Enrollment: 280

Participant Flow

Recruitment Details	Between June 9, 2016, and July 20, 2017, Investigators randomized 280 subjects into the study at 24 sites in the US, Europe, and Australia/New Zealand (50-75% of subjects treated in the US). The final subject completed 6 month follow-up on January 30, 2018. Anticipated data of study completion (last subject, last visit) is Q3, 2019.
Pre-assignment Details

Arm/Group Title	Covera Vascular Covered Stent Following PTA	PTA Only Using Uncoated PTA Balloon
Arm/Group Description	Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.	Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
Period Title: Overall Study
Started	142	138
Completed	130	123
Not Completed	12	15
Reason Not Completed
Withdrawal by Subject	1	1
Death	7	9
Physician Decision	1	0
Lost to Follow-up	2	1
Erroneously enrolled	1	0
Missed 6-month follow-up visit	0	4

Baseline Characteristics

Arm/Group Title		Covera Vascular Covered Stent Following PTA	PTA Only Using Uncoated PTA Balloon	Total
Arm/Group Description		Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.	Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only	Total of all reporting groups
Overall Number of Baseline Participants		142	138	280
Baseline Analysis Population Description		[Not Specified]
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	142 participants	138 participants	280 participants
< 65 years		79 55.6%	76 55.1%	155 55.4%
≥ 65 and < 75 years		36 25.4%	45 32.6%	81 28.9%
≥ 75 years		27 19.0%	17 12.3%	44 15.7%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	142 participants	138 participants	280 participants
	Female	53 37.3%	54 39.1%	107 38.2%
	Male	89 62.7%	84 60.9%	173 61.8%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	142 participants	138 participants	280 participants
	Hispanic or Latino	48 33.8%	54 39.1%	102 36.4%
	Not Hispanic or Latino	93 65.5%	84 60.9%	177 63.2%
	Unknown or Not Reported	1 0.7%	0 0.0%	1 0.4%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	142 participants	138 participants	280 participants
Asian		0 0.0%	6 4.3%	6 2.1%
Black or African American		36 25.4%	36 26.1%	72 25.7%
Native Hawaiian or Other Pacific Island		2 1.4%	0 0.0%	2 0.7%
White		100 70.4%	92 66.7%	192 68.6%
Other		4 2.8%	4 2.9%	8 2.9%
Region of Enrollment [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	142 participants	138 participants	280 participants
United States		131 92.3%	131 94.9%	262 93.6%
Europe		7 4.9%	3 2.2%	10 3.6%
Australia		4 2.8%	4 2.9%	8 2.9%
		[1] Measure Description: Please note that New Zealand sites are included in the Australia section.
Medical History [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	142 participants	138 participants	280 participants
Diabetes (Type 1 and 2)		108 76.1%	103 74.6%	211 75.4%
Dyslipidemia		95 66.9%	85 61.6%	180 64.3%
Hypertension		139 97.9%	133 96.4%	272 97.1%
Cigarette Smoking (current or former)		62 43.7%	62 44.9%	124 44.3%
Cardiovascular Disease		95 66.9%	95 68.8%	190 67.9%
Other Disease		129 90.8%	129 93.5%	258 92.1%
		[1] Measure Description: Medical history information, including medical risk factors as well as selected medical history background for the ITT population is provided. "Other Disease" category includes Bleeding Disorder, Cancer, Steal Syndrome, and other.
AV Access Circuit Description: Target Limb; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	142 participants	138 participants	280 participants
Left Arm		106 74.6%	110 79.7%	216 77.1%
Right Arm		36 25.4%	28 20.3%	64 22.9%
AV Access Circuit Description: Access Position; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	142 participants	138 participants	280 participants
Forearm		9 6.3%	8 5.8%	17 6.1%
Upper Arm		132 93.0%	130 94.2%	262 93.6%
At Elbow		1 0.7%	0 0.0%	1 0.4%
AV Access Circuit Description:Inflow Artery; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	142 participants	138 participants	280 participants
Axillary		2 1.4%	2 1.4%	4 1.4%
Brachial		128 90.1%	127 92.0%	255 91.1%
Radial		12 8.5%	9 6.5%	21 7.5%
AV Access Circuit Description: Outflow Vein; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	142 participants	138 participants	280 participants
Axillary		2 1.4%	1 0.7%	3 1.1%
Basilic		35 24.6%	42 30.4%	77 27.5%
Cephalic		105 73.9%	95 68.8%	200 71.4%
AV Access Circuit Description: Fistula Configuration; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	142 participants	138 participants	280 participants
Radiocephalic		12 8.5%	9 6.5%	21 7.5%
Brachiocephalic		84 59.2%	78 56.5%	162 57.9%
Transposed Brachiobasilic		27 19.0%	37 26.8%	64 22.9%
All Other		19 13.4%	14 10.1%	33 11.8%
AV Access Circuit Description: Transposed; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	142 participants	138 participants	280 participants
Yes		36 25.4%	43 31.2%	79 28.2%
No		106 74.6%	95 68.8%	201 71.8%

Outcome Measures

1. Primary Outcome

Title	Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency (TLPP)
Description	TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at, or adjacent to,the original treatment site or until the extremity is abandoned for permanent access. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV fistula due to inability to treat the original treatment area. COVERA Vascular Covered Stent (following PTA) is evaluated against subjects treated PTA alone.
Time Frame	6 months post index procedure

Outcome Measure Data

Analysis Population Description

Number of Participants with Target Lesion Primary Patency. Modified Intended to Treat (mITT) population results were analyzed for this effectiveness endpoint. N = number of subjects in mITT population with evaluable data. Excluded subjects that discontinued, expired and or access abandoned prior to day 15.

Arm/Group Title	Covera Vascular Covered Stent Following PTA	PTA Only Using Uncoated PTA Balloon
Arm/Group Description:	Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.	Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
Overall Number of Participants Analyzed	134	117
Measure Type: Count of Participants; Unit of Measure: Participants
	105 78.4%	55 47.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PTA Only Using Uncoated PTA Balloon
	Comments	Hypothesis: The (survival) rate in subjects treated with the COVERA Vascular Covered Stent (following PTA) with respect to TLPP through 6 months is greater than that in subjects treated with PTA alone in the treatment of stenoses in the upper extremity venous outflow of subjects dializing with an AV fistula. Sample size calculation: 238 randomized subjects [214 evaluable] will give 92% power with one-sided type 1 error = 0.025.
	Type of Statistical Test	Superiority
	Comments	TLPP evaluated at 6 months post-index procedure to assess if TLPP of COVERA is superior to that of PTA alone, by direct comparison.
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Test successful if the one-side p-value is less than 0.025 and the result is in favor of the COVERA Vascular Covered Stent.
	Method	Chi-squared
	Comments	[Not Specified]

2. Primary Outcome

Title	Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events
Description	Safety is defined as freedom from any adverse event(s) (AEs), localized or systemic, that reasonably suggests the involvement of the AV access circuit (not including stenosis or thrombosis) that require or result in any of the following alone or in combination: additional interventions (including surgery); in-patient hospitalization or prolongation of an existing hospitalization; or death.
Time Frame	30 days post index procedure

Outcome Measure Data

Analysis Population Description

Number of Participants Free from Primary Safety Events. All Intended to Treat Subjects (ITT) are included in this analysis. Primary safety endpoint evaluated against standard PTA alone.2 subjects excluded from N COVERA due to discontinuation or death prior to day 23 of follow up. One subject excluded from N PTA arm due to death prior to follow up.

Arm/Group Title	Covera Vascular Covered Stent Following PTA	PTA Only Using Uncoated PTA Balloon
Arm/Group Description:	Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.	Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
Overall Number of Participants Analyzed	140	137
Measure Type: Count of Participants; Unit of Measure: Participants
	133 95.0%	132 96.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PTA Only Using Uncoated PTA Balloon
	Comments	Hypothesis: The safety rate in subjects treated with the COVERA Vascular Covered Stent (following PTA) is non-inferior to the safety rate in subjects treated with PTA alone through 30 days in the treatment of stenotic lesions. Sample size: 238 randomized subjects [226 evaluable] will give 85% power with one-sided type 1 error = 0.025.
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority Farrington and Manning Exact Test is used to test the primary safety hypothesis. The test is successful if the one-sided p-value is less than 0.025.
Statistical Test of Hypothesis	P-Value	0.0022
	Comments	[Not Specified]
	Method	Farrington and Manning
	Comments	Non-inferiority test with non-inferiority margin of 10%.

3. Secondary Outcome

Title	Number of Patients With Target Lesion Primary Patency (TLPP) at 12 Months Post Index Procedure
Description	TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV fistula due to inability to treat the original treatment area.
Time Frame	12 months post-index procedure

Outcome Measure Data

Analysis Population Description

Number of Participants with Target Lesion Primary Patency (TLPP). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 12 month follow-up or did not meet endpoint inclusion criteria.

Arm/Group Title	Covera Vascular Covered Stent Following PTA	PTA Only Using Uncoated PTA Balloon
Arm/Group Description:	Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.	Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
Overall Number of Participants Analyzed	124	114
Measure Type: Count of Participants; Unit of Measure: Participants
	67 54.0%	23 20.2%

4. Secondary Outcome

Title	Number of Participants With Access Circuit Primary Patency (ACPP).
Description	ACPP is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. ACPP ends with a reintervention anywhere within the access circuit. Vessel rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis. Testing of this secondary endpoint is performed in a hierarchical fashion. Thus, In order to perform hypothesis test of ACPP at 6-month, TLPP at 12-months must be successful.
Time Frame	6 months post index procedure

Outcome Measure Data

Analysis Population Description

Number of Participants with Access Circuit Primary Patency (ACPP). Modified Intended to Treat (mITT) population results were analyzed for this effectiveness endpoint. N = number of subjects in mITT population with evaluable data. Excluded subjects that discontinued, expired and or access abandoned prior to day 15.

Arm/Group Title	Covera Vascular Covered Stent Following PTA	PTA Only Using Uncoated PTA Balloon
Arm/Group Description:	Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.	Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
Overall Number of Participants Analyzed	134	117
Measure Type: Count of Participants; Unit of Measure: Participants
	67 50.0%	50 42.7%

5. Secondary Outcome

Title	Number of Participants With Target Lesion Primary Patency (TLPP)
Description	Defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access. mITT subjects results are presented. N= number of subjects in the mITT Population with evaluable data. Evaluation through 1, 3, 18 and 24 months post index procedure.
Time Frame	1, 3, 18 and 24 months post index procedure

Outcome Measure Data

Analysis Population Description

Number of Participants with Target Lesion Primary Patency (TLPP). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days or 90 days follow-up or did not meet endpoint inclusion criteria.

Arm/Group Title		Covera Vascular Covered Stent Following PTA	PTA Only Using Uncoated PTA Balloon
Arm/Group Description:		Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.	Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
Overall Number of Participants Analyzed		140	125
Measure Type: Count of Participants; Unit of Measure: Participants
TLPP at 30-day Follow-up	Number Analyzed	140 participants	125 participants
		136 97.1%	122 97.6%
TLPP at 90-day Follow-up	Number Analyzed	138 participants	121 participants
		125 90.6%	98 81.0%
TLPP at 18 month Follow-Up	Number Analyzed	116 participants	111 participants
		44 37.9%	16 14.4%
TLPP at 24 month Follow-Up	Number Analyzed	114 participants	110 participants
		40 35.1%	10 9.1%

6. Secondary Outcome

Title	Number of Participants With Access Circuit Primary Patency (ACPP)
Description	ACPP is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. N = number of subjects in the mITT Population with evaluable data.
Time Frame	1, 3, 12, 18, and 24 months post index procedure

Outcome Measure Data

Analysis Population Description

Number of Participants with ACPP by Follow-up Period (mITT subjects). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days and 90 days follow-up or did not meet endpoint inclusion criteria.

Arm/Group Title		Covera Vascular Covered Stent Following PTA	PTA Only Using Uncoated PTA Balloon
Arm/Group Description:		Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.	Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
Overall Number of Participants Analyzed		140	125
Measure Type: Count of Participants; Unit of Measure: Participants
ACPP at 30-day Follow-up	Number Analyzed	140 participants	125 participants
		133 95.0%	120 96.0%
ACPP at 90-day Follow-up	Number Analyzed	138 participants	121 participants
		110 79.7%	95 78.5%
ACPP at 12-month Follow-Up	Number Analyzed	128 participants	114 participants
		33 25.8%	19 16.7%
ACPP at 18 month Follow-Up	Number Analyzed	122 participants	112 participants
		17 13.9%	13 11.6%
ACPP at 24 month Follow-Up	Number Analyzed	121 participants	111 participants
		13 10.7%	9 8.1%

7. Secondary Outcome

Title	Number of Participants Free From Device and Procedure Related AEs Involving the AV Access Circuit
Description	Number of Participants Free from Device and Procedure Related AEs Involving the AV Access Circuit (ITT population). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria. The relationships with device/procedure of the events are based on CEC adjudications.
Time Frame	Evaluation through 1, 3, 6, 12, 18, and 24 months post-index procedure

Outcome Measure Data

Analysis Population Description

Number of Participants Free from Device and Procedure (DP) Related AEs Involving the AV Access Circuit (ITT subjects).

Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria.

Arm/Group Title		Covera Vascular Covered Stent Following PTA	PTA Only Using Uncoated PTA Balloon
Arm/Group Description:		Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.	Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
Overall Number of Participants Analyzed		140	137
Measure Type: Count of Participants; Unit of Measure: Participants
DP AEs Free at 30 day Follow-up	Number Analyzed	140 participants	137 participants
		127 90.7%	132 96.4%
DP AEs Free at 90 day Follow-up	Number Analyzed	138 participants	133 participants
		124 89.9%	127 95.5%
DP AEs Free at 6 month Follow-up	Number Analyzed	134 participants	129 participants
		118 88.1%	122 94.6%
DP AEs Free at 12 month Follow-up	Number Analyzed	126 participants	123 participants
		108 85.7%	112 91.1%
DP AEs Free at 18 month Follow-Up	Number Analyzed	120 participants	114 participants
		99 82.5%	102 89.5%
DP AEs Free at 24 month Follow-up	Number Analyzed	114 participants	104 participants
		91 79.8%	90 86.5%

8. Secondary Outcome

Title	Total Number of Arteriovenous (AV) Access Circuit Reinterventions
Description	Defined as the number of reinterventions to the AV access circuit until access abandonment or through study completion. Whereas the outcome measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, the interim report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study. MITT results are presented for this analysis.
Time Frame	1, 3, 6, 12, 18 and 24 months post index procedure

Outcome Measure Data

Analysis Population Description

The (n) in each follow-up periods vary from overall enrollment (N) as some subjects discontinued participation before each follow-up or did not meet endpoint inclusion criteria.

The total number of Reinterventions by Follow-Up Period was analyzed as opposed to the number of subjects with at least one AV Access Circuit Reintervention -mITT subjects

Arm/Group Title		Covera Vascular Covered Stent Following PTA	PTA Only Using Uncoated PTA Balloon
Arm/Group Description:		Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.	Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
Overall Number of Participants Analyzed		112	107
Measure Type: Number; Unit of Measure: AV Access Circuit Reinterventions
AV Access Circuit Reinterventions at 30 days	Number Analyzed	7 participants	6 participants
		7	6
AV Access Circuit Reinterventions at 90 days	Number Analyzed	30 participants	27 participants
		35	34
AV Access Circuit Reinterventions at 6 months	Number Analyzed	69 participants	71 participants
		103	107
AV Access Circuit Reinterventions at 12 months	Number Analyzed	101 participants	102 participants
		226	241
AV Access Circuit Reinterventions at 18 months	Number Analyzed	109 participants	104 participants
		310	313
AV Access Circuit Reinterventions at 24 months	Number Analyzed	112 participants	107 participants
		390	398

9. Secondary Outcome

Title	Total Number of Target Lesion Reinterventions
Description	Total Number of Target Lesion Reinterventions defined as the number of reinterventions to maintain target lesion patency (mITT subjects). Whereas the outcome measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months.
Time Frame	1, 3, 6, 12, 18 and 24 months post index procedure

Outcome Measure Data

Analysis Population Description

The (n) in each follow-up periods vary from overall enrollment (N) as some subjects discontinued participation before each follow-up or did not meet endpoint inclusion criteria.

The total number of Target Lesion Reinterventions by Follow-Up Period was analyzed as opposed to the number of subjects with at least one AV Target Lesion Reintervention.

Arm/Group Title		Covera Vascular Covered Stent Following PTA	PTA Only Using Uncoated PTA Balloon
Arm/Group Description:		Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.	Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
Overall Number of Participants Analyzed		76	103
Measure Type: Number; Unit of Measure: Target Lesion Reinterventions
Target Lesion Reinterventions at 30 day Follow-up	Number Analyzed	5 participants	3 participants
		5	3
Target Lesion Reinterventions at 90 day Follow-up	Number Analyzed	13 participants	22 participants
		16	24
Target Lesion Reinterventions 6 month Follow-up	Number Analyzed	31 participants	66 participants
		40	92
Target Lesion Reinterventions at 12 month Follow-Up	Number Analyzed	59 participants	100 participants
		95	196
Target Lesion Reintervention at 18 month Follow-Up	Number Analyzed	73 participants	101 participants
		139	248
Target Lesion Reintervention at 24 month Follow-Up	Number Analyzed	76 participants	103 participants
		179	309

10. Secondary Outcome

Title	Index of Patency Function (IPF)
Description	IPF is defined as the time from the index study procedure to study completion or access abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis. A visit is defined as one (1) procedural event, regardless of the number or type of interventions performed during the visit. The index procedure is counted as the first visit to ensure all subjects have a denominator of at least one. Whereas the measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months. The IPF is representative of the number of days between interventions to maintain access circuit patency. Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions. mITT results are analyzed.
Time Frame	1, 3, 6, 12, 18 and 24 months post index procedure

Outcome Measure Data

Analysis Population Description

Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria.

mITT subjects results are presented.

Arm/Group Title		Covera Vascular Covered Stent Following PTA	PTA Only Using Uncoated PTA Balloon
Arm/Group Description:		Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.	Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
Overall Number of Participants Analyzed		140	125
Mean (Standard Deviation); Unit of Measure: Days
Index of Patency at 30 days Follow-up	Number Analyzed	140 participants	125 participants
		29.22 (3.420)	29.28 (3.219)
Index of Patency at 90 days Follow-up	Number Analyzed	138 participants	121 participants
		79.41 (20.511)	78.98 (20.770)
Index of Patency at 6 month Follow-up	Number Analyzed	134 participants	117 participants
		126.06 (54.449)	116.11 (53.175)
Index of Patency at 12 month Follow-up	Number Analyzed	129 participants	115 participants
		172.04 (108.690)	146.09 (89.723)
Index of Patency at 18 month Follow-up	Number Analyzed	124 participants	113 participants
		199.31 (145.278)	175.70 (125.145)
Index of Patency at 24 month Follow-up	Number Analyzed	123 participants	111 participants
		219.45 (178.916)	180.59 (135.216)

11. Secondary Outcome

Title	Index of Patency Function - Target Lesion (IPF-T)
Description	IPF-T (Index of Patency Function - Target Lesion) is defined as the time from the index study procedure to study completion or complete access abandonment divided by the number of visits for a reintervention performed at the target lesion in order to maintain vascular access for hemodialysis. Whereas the measure time frames for the overall study are 1, 3, 6, 12, 18 and 24 months. The IPF for target lesion patency is representative of the approximate (mean) number of days between interventions to maintain target lesion patency. Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions.
Time Frame	1, 3, 6, 12, 18 and 24 months post index procedure

Outcome Measure Data

Analysis Population Description

Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria.

mITT subjects results are presented.

Arm/Group Title		Covera Vascular Covered Stent Following PTA	PTA Only Using Uncoated PTA Balloon
Arm/Group Description:		Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.	Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
Overall Number of Participants Analyzed		140	125
Mean (Standard Deviation); Unit of Measure: Days
IPTF-T at 30 days Follow-Up	Number Analyzed	140 participants	125 participants
		29.44 (2.958)	29.64 (2.305)
IPTF-T at 90 days Follow-Up	Number Analyzed	137 participants	120 participants
		85.15 (15.349)	81.35 (18.243)
IPTF-T at 6 month Follow-Up	Number Analyzed	133 participants	116 participants
		156.32 (43.724)	121.75 (51.940)
IPTF-T at 12 month Follow-up	Number Analyzed	122 participants	114 participants
		256.32 (115.626)	160.37 (87.504)
IPTF-T at 18 month Follow-Up	Number Analyzed	114 participants	112 participants
		318.24 (179.651)	200.64 (130.055)
IPTF-T at 24 month Follow-Up	Number Analyzed	112 participants	110 participants
		380.40 (249.548)	217.57 (158.373)

12. Secondary Outcome

Title	Number of Participants With Post-intervention Secondary Patency
Description	Secondary Patency is defined as the interval after the index intervention until the access is abandoned. Multiple repetitive treatments can be included in post-intervention secondary patency. Whereas the measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, the interim report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study. mITT subjects results are presented.
Time Frame	1, 3, 6, 12, 18 and 24 months post index procedure

Outcome Measure Data

Analysis Population Description

Post-Intervention Secondary Patency by Follow-Up Period (mITT Subjects). (n) varies in relation to the number of failures (access abandonment) recorded at 30 days, 90 days and 6 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.

Arm/Group Title		Covera Vascular Covered Stent Following PTA	PTA Only Using Uncoated PTA Balloon
Arm/Group Description:		Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.	Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
Overall Number of Participants Analyzed		140	125
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with Secondary Patency at 30 days	Number Analyzed	140 participants	125 participants
		139 99.3%	125 100.0%
Participants with Secondary Patency at 90 days	Number Analyzed	138 participants	120 participants
		136 98.6%	119 99.2%
Participants with Secondary Patency at 6 months	Number Analyzed	134 participants	115 participants
		131 97.8%	113 98.3%
Participants with Secondary Patency at 12 months	Number Analyzed	122 participants	105 participants
		115 94.3%	102 97.1%
Participants with Secondary Patency at 18 months	Number Analyzed	112 participants	94 participants
		103 92.0%	91 96.8%
Participants with Secondary Patency at 24 months	Number Analyzed	104 participants	82 participants
		95 91.3%	76 92.7%

13. Secondary Outcome

Title	Number of Participants With Technical Success
Description	Technical Success is defined as successful deployment, based on the operator's opinion, of the implant to the intended location assessed at the time of the index procedure. Therefore, for this measure, only COVERA data are relevant. mITT results are presented. Number of participants (n) included in this analysis is different from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria. Technical success was assessed on the day the index procedure was performed, which may be a different day for each participant.
Time Frame	On Day of Index Procedure

Outcome Measure Data

Analysis Population Description

Number of Participants with Acute Technical Success (mITT Subjects). Please note that "Technical Success is defined as successful deployment, based on the operator's opinion, of the implant to the intended location assessed at the time of the index procedure." Therefore, for this measure, only COVERA data are relevant.

Arm/Group Title	Covera Vascular Covered Stent Following PTA
Arm/Group Description:	Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
Overall Number of Participants Analyzed	140
Measure Type: Count of Participants; Unit of Measure: Participants
	140 100.0%

14. Secondary Outcome

Title	Number of Participants With Procedure Success
Description	Procedure Success is defined as anatomic success and resolution of the pre-procedural clinical indicator(s) (clinical success) of a hemodynamically significant stenosis. Procedure success was assessed on the day the index procedure was performed, which may be a different day for each participant.
Time Frame	On Day of Index Procedure

Outcome Measure Data

Analysis Population Description

Procedure Success (mITT Subjects). Number of participants (n) included in this analysis is different from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria.

Arm/Group Title	Covera Vascular Covered Stent Following PTA	PTA Only Using Uncoated PTA Balloon
Arm/Group Description:	Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.	Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
Overall Number of Participants Analyzed	140	126
Measure Type: Count of Participants; Unit of Measure: Participants
	138 98.6%	124 98.4%

Adverse Events

Time Frame	Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Adverse Event Reporting Description	Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated. Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.
Arm/Group Title	Covera Vascular Covered Stent Following PTA		PTA Only Using Uncoated PTA Balloon
Arm/Group Description	Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.		Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only
All-Cause Mortality
	Covera Vascular Covered Stent Following PTA		PTA Only Using Uncoated PTA Balloon
	Affected / at Risk (%)		Affected / at Risk (%)
Total	27/142 (19.01%)		32/138 (23.19%)
Serious Adverse Events
	Covera Vascular Covered Stent Following PTA		PTA Only Using Uncoated PTA Balloon
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	107/142 (75.35%)		110/138 (79.71%)
Blood and lymphatic system disorders
Blood and lymphatic † 1	4/142 (2.82%)	4	4/138 (2.90%)	4
Cardiac disorders
Cardiac disorders † 1	31/142 (21.83%)	31	40/138 (28.99%)	40
Eye disorders
Eye disorders † 1	1/142 (0.70%)	1	0/138 (0.00%)	0
Gastrointestinal disorders
Gastrointestinal † 1	20/142 (14.08%)	20	13/138 (9.42%)	13
General disorders
General disorders and administration site conditions † 1	19/142 (13.38%)	19	6/138 (4.35%)	6
Infections and infestations
Infections and Infestations † 1	47/142 (33.10%)	47	37/138 (26.81%)	37
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications † 1	37/142 (26.06%)	37	34/138 (24.64%)	34
Investigations
Investigations † 1	1/142 (0.70%)	1	0/138 (0.00%)	0
Metabolism and nutrition disorders
Metabolism and nutrition † 1	27/142 (19.01%)	27	23/138 (16.67%)	23
Musculoskeletal and connective tissue disorders
Muskuloskeletal and connective disorders † 1	3/142 (2.11%)	3	1/138 (0.72%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified † 1	1/142 (0.70%)	1	6/138 (4.35%)	6
Nervous system disorders
Nervous system † 1	14/142 (9.86%)	14	14/138 (10.14%)	14
Psychiatric disorders
Psychiatric † 1	1/142 (0.70%)	1	5/138 (3.62%)	5
Renal and urinary disorders
Renal and urinary † 1	12/142 (8.45%)	12	14/138 (10.14%)	14
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal † 1	19/142 (13.38%)	19	15/138 (10.87%)	15
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue † 1	6/142 (4.23%)	6	3/138 (2.17%)	3
Surgical and medical procedures
Surgical and medical procedures † 1	1/142 (0.70%)	1	0/138 (0.00%)	0
Vascular disorders
Vascular † 1	25/142 (17.61%)	25	24/138 (17.39%)	24
1 Term from vocabulary, MedDRA (16.1); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Covera Vascular Covered Stent Following PTA		PTA Only Using Uncoated PTA Balloon
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	119/142 (83.80%)		120/138 (86.96%)
Blood and lymphatic system disorders
Blood and lymphatic † 1	6/142 (4.23%)	6	9/138 (6.52%)	9
Cardiac disorders
Cardiac † 1	39/142 (27.46%)	39	44/138 (31.88%)	44
Ear and labyrinth disorders
Ear and labyrinth † 1	2/142 (1.41%)	2	1/138 (0.72%)	1
Endocrine disorders
Endocrine † 1	1/142 (0.70%)	1	3/138 (2.17%)	3
Eye disorders
Eye † 1	3/142 (2.11%)	3	1/138 (0.72%)	1
Gastrointestinal disorders
Gastrointestinal † 1	29/142 (20.42%)	29	24/138 (17.39%)	24
General disorders
General disorders † 1	25/142 (17.61%)	25	15/138 (10.87%)	15
Hepatobiliary disorders
Hepatobiliary † 1	3/142 (2.11%)	3	8/138 (5.80%)	8
Immune system disorders
Immune system † 1	0/142 (0.00%)	0	2/138 (1.45%)	2
Infections and infestations
Infections and Infestations † 1	60/142 (42.25%)	60	43/138 (31.16%)	43
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications † 1	56/142 (39.44%)	56	45/138 (32.61%)	45
Investigations
Investigations † 1 [1]	4/142 (2.82%)	4	4/138 (2.90%)	4
Metabolism and nutrition disorders
Metabolism and nutrition disorders † 1	33/142 (23.24%)	33	33/138 (23.91%)	33
Musculoskeletal and connective tissue disorders
Muskuloskeletal and connective tissues † 1	20/142 (14.08%)	20	12/138 (8.70%)	12
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm benign, malignant and unspecified † 1	3/142 (2.11%)	3	6/138 (4.35%)	6
Nervous system disorders
Nervous system disorders † 1	21/142 (14.79%)	21	21/138 (15.22%)	21
Psychiatric disorders
Psychiatric † 1	2/142 (1.41%)	2	9/138 (6.52%)	9
Renal and urinary disorders
Renal and urinary † 1	13/142 (9.15%)	13	14/138 (10.14%)	14
Reproductive system and breast disorders
Reproductive system and breast † 1	1/142 (0.70%)	1	0/138 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal † 1	25/142 (17.61%)	25	24/138 (17.39%)	24
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue † 1	11/142 (7.75%)	11	7/138 (5.07%)	7
Vascular disorders
Vascular † 1	37/142 (26.06%)	37	35/138 (25.36%)	35
1 Term from vocabulary, MedDRA (16.1); † Indicates events were collected by systematic assessment; [1] Electrocardiogram ST segment depression, liver function, abnormal and test abnormal, peritoneal effluent and troponin T increase.

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Prior to PI publication of site results, sponsor requires publication of multi-centers results.

Results Point of Contact

• Name/Title: Heather Lam, Associate Project Manager, Clinical Affairs
• Organization: BD/Bard
• Phone: (763) 390-8616
• EMail: heather.lam@bd.com

• Responsible Party: C. R. Bard
• ClinicalTrials.gov Identifier: NCT02649946
• Other Study ID Numbers: BPV-14-005
• First Submitted: January 4, 2016
• First Posted: January 8, 2016
• Results First Submitted: March 15, 2019
• Results First Posted: May 13, 2019
• Last Update Posted: December 21, 2021