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Trial record 1 of 3 for:    IN.PACT AV
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IN.PACT™ AV Access Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041467
Recruitment Status : Active, not recruiting
First Posted : February 2, 2017
Results First Posted : February 27, 2020
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Arteriovenous Fistula Stenosis
Arteriovenous Fistula Occlusion
Arteriovenous Fistula
Fistula
Interventions Device: IN.PACT AV DCB
Device: Standard Balloon Angioplasty
Enrollment 330
Recruitment Details 330 subjects from 21 US sites and 8 OUS sites contributed to the global cohort. 204 of subjects came from U.S. sites, 112 of subjects came from Japan sites, and 14 of subjects came from New Zealand sites. There was no minimum enrollment requirement at each site; individual sites were not allowed to enroll more than 20% of the total study subjects.
Pre-assignment Details A total of 488 patients were consented to be reviewed for enrollment. 158 patients were not enrolled in the study. 170 subjects were randomized to IN.PACT AV Drug Coated Balloon treatment and 160 subjects were randomized to the Standard PTA Treatment.
Arm/Group Title IN.PACT AV DCB Standard Balloon Angioplasty
Hide Arm/Group Description

PTA will be performed using the IN.PACT AV Drug Coated Balloon.

IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

PTA will be performed using a commercially available uncoated PTA balloon.

Standard Balloon Angioplasty: Standard PTA Balloon

Period Title: Overall Study
Started 170 160
Completed 0 0
Not Completed 170 160
Arm/Group Title IN.PACT AV DCB Standard Balloon Angioplasty Total
Hide Arm/Group Description

PTA will be performed using the IN.PACT AV Drug Coated Balloon.

IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

PTA will be performed using a commercially available uncoated PTA balloon.

Standard Balloon Angioplasty: Standard PTA Balloon

Total of all reporting groups
Overall Number of Baseline Participants 170 160 330
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 170 participants 160 participants 330 participants
65.8  (13.1) 65.5  (13.4) 65.6  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants 160 participants 330 participants
Female
58
  34.1%
59
  36.9%
117
  35.5%
Male
112
  65.9%
101
  63.1%
213
  64.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 170 participants 160 participants 330 participants
42
  24.7%
46
  28.7%
88
  26.7%
Black or African American Number Analyzed 170 participants 160 participants 330 participants
54
  31.8%
48
  30.0%
102
  30.9%
Asian Number Analyzed 170 participants 160 participants 330 participants
63
  37.1%
57
  35.6%
120
  36.4%
Native Hawaiian or Other Pacific Islander Number Analyzed 170 participants 160 participants 330 participants
6
   3.5%
4
   2.5%
10
   3.0%
American Indian or Alaska Native Number Analyzed 170 participants 160 participants 330 participants
0
   0.0%
0
   0.0%
0
   0.0%
Other Number Analyzed 170 participants 160 participants 330 participants
5
   2.9%
5
   3.1%
10
   3.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
New Zealand Number Analyzed 170 participants 160 participants 330 participants
8 6 14
United States Number Analyzed 170 participants 160 participants 330 participants
104 100 204
Japan Number Analyzed 170 participants 160 participants 330 participants
58 54 112
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 157 participants 324 participants
Hispanic or Latino
15
   9.0%
14
   8.9%
29
   9.0%
Not Hispanic or Latino
152
  91.0%
143
  91.1%
295
  91.0%
[1]
Measure Analysis Population Description: 3 subjects in each treatment group did not provide data regarding ethnicity.
1.Primary Outcome
Title Number of Participants With Target Lesion Primary Patency Though 6 Months
Hide Description Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.
Time Frame 6 Months Post-Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable subjects were all subjects with events or subjects without events but had at least 150 days of clinical follow-up were counted as evaluable subjects. If a subject had no event and abandoned AV Access circuit within 150 days the subject will be considered not evaluable for 6-months effectiveness endpoints.
Arm/Group Title IN.PACT AV DCB Standard Balloon Angioplasty
Hide Arm/Group Description:

PTA will be performed using the IN.PACT AV Drug Coated Balloon.

IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

PTA will be performed using a commercially available uncoated PTA balloon.

Standard Balloon Angioplasty: Standard PTA Balloon

Overall Number of Participants Analyzed 152 148
Measure Type: Count of Participants
Unit of Measure: Participants
125
  82.2%
88
  59.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IN.PACT AV DCB, Standard Balloon Angioplasty
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method One-sided Z-test
Comments [Not Specified]
2.Primary Outcome
Title Primary Safety Endpoint - Serious Adverse Event Rate
Hide Description Serious Adverse Event (SAE) rate involving the AV access circuit
Time Frame 30 days post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with events or subjects without events but had at least 23 days of clinical follow-up were counted as evaluable subjects.
Arm/Group Title IN.PACT AV DCB Standard Balloon Angioplasty
Hide Arm/Group Description:

PTA will be performed using the IN.PACT AV Drug Coated Balloon.

IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

PTA will be performed using a commercially available uncoated PTA balloon.

Standard Balloon Angioplasty: Standard PTA Balloon

Overall Number of Participants Analyzed 166 158
Measure Type: Count of Participants
Unit of Measure: Participants
7
   4.2%
7
   4.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IN.PACT AV DCB, Standard Balloon Angioplasty
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority p-values for the primary safety endpoint was based on the Farrington-Manning non-inferiority test with a margin of 7.5%.
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Farrington-Manning Method
Comments [Not Specified]
3.Secondary Outcome
Title Access Circuit Primary Patency
Hide Description Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-procedure. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.
Time Frame 3, 6, 9, 12, 18, and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
There is no planned test for 3 Month endpoint, therefore no p value at 3 Months.
Arm/Group Title IN.PACT AV DCB Standard Balloon Angioplasty
Hide Arm/Group Description:

PTA will be performed using the IN.PACT AV Drug Coated Balloon.

IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

PTA will be performed using a commercially available uncoated PTA balloon.

Standard Balloon Angioplasty: Standard PTA Balloon

Overall Number of Participants Analyzed 170 160
Measure Type: Number
Unit of Measure: % Access Circuit Primary Patency
3 Months 91.4 84.6
6 Months 72.5 48.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IN.PACT AV DCB, Standard Balloon Angioplasty
Comments Kaplan-Meier method was used to estimate access circuit primary patency.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments There is no planned test for 3 Month endpoint, therefore no p-value at 3 Months. P-value listed is at 6 Months.
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Target Lesion Primary Patency
Hide Description Percent of subjects with freedom from clinical drive target lesion revascularization or access thrombosis occurring in the target lesion. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.
Time Frame 3, 9, 12, 18, and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IN.PACT AV DCB Standard Balloon Angioplasty
Hide Arm/Group Description:

PTA will be performed using the IN.PACT AV Drug Coated Balloon.

IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

PTA will be performed using a commercially available uncoated PTA balloon.

Standard Balloon Angioplasty: Standard PTA Balloon

Overall Number of Participants Analyzed 170 160
Measure Type: Number
Unit of Measure: % of Target Lesion Primary Patency
96.9 90.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IN.PACT AV DCB, Standard Balloon Angioplasty
Comments Kaplan-Meier survival curve was used to estimate target lesion primary patency.
Type of Statistical Test Other
Comments There is no planned test for 3 Month endpoint, therefore no p-value at 3 Months.
Other Statistical Analysis Survival analysis will be performed using Kaplan-Meier method.
5.Secondary Outcome
Title Cumulative Target Lesion Revascularizations
Hide Description The proportion of subjects with target lesion revascularizations. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.
Time Frame 3, 6, 9, 12, 18, and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects are included in the analyses up to the time consent was withdrawn, or they were exited, whichever is earlier.
Arm/Group Title IN.PACT AV DCB Standard Balloon Angioplasty
Hide Arm/Group Description:

PTA will be performed using the IN.PACT AV Drug Coated Balloon.

IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

PTA will be performed using a commercially available uncoated PTA balloon.

Standard Balloon Angioplasty: Standard PTA Balloon

Overall Number of Participants Analyzed 170 160
Measure Type: Count of Participants
Unit of Measure: Participants
3 Months Number Analyzed 160 participants 155 participants
8
   5.0%
19
  12.3%
6 Months Number Analyzed 153 participants 148 participants
25
  16.3%
59
  39.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IN.PACT AV DCB, Standard Balloon Angioplasty
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments There is no planned test for 3 Month endpoint, therefore no p value at 3 Months. P value is at 6 Months.
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Total Number of Interventions Required to Maintain Target Lesion Patency
Hide Description The number of target lesion revascularizations per treatment arm through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-procedure. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.
Time Frame 3, 6, 9, 12, 18, and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IN.PACT AV DCB Standard Balloon Angioplasty
Hide Arm/Group Description:

PTA will be performed using the IN.PACT AV Drug Coated Balloon.

IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

PTA will be performed using a commercially available uncoated PTA balloon.

Standard Balloon Angioplasty: Standard PTA Balloon

Overall Number of Participants Analyzed 170 160
Measure Type: Number
Unit of Measure: Total number of interventions
3 Months 10 19
6 Months 32 70
7.Secondary Outcome
Title Total Number of Interventions Required to Maintain Access Circuit Patency
Hide Description The number of re-interventions in the target lesion and/or access circuit. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.
Time Frame 3, 6, 9, 12, 18, and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IN.PACT AV DCB Standard Balloon Angioplasty
Hide Arm/Group Description:

PTA will be performed using the IN.PACT AV Drug Coated Balloon.

IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

PTA will be performed using a commercially available uncoated PTA balloon.

Standard Balloon Angioplasty: Standard PTA Balloon

Overall Number of Participants Analyzed 170 160
Measure Type: Number
Unit of Measure: Total number of interventons
3 Months 16 23
6 Months 44 82
8.Secondary Outcome
Title Cumulative Access Circuit Thromboses
Hide Description Proportion of subjects with access circuit thrombosis. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.
Time Frame 3, 6, 9, 12, 18, and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects withdrawn or lost-to-follow-up are included in the analyses up to the time consent was withdrawn, or they were exited, whichever is earlier.
Arm/Group Title IN.PACT AV DCB Standard Balloon Angioplasty
Hide Arm/Group Description:

PTA will be performed using the IN.PACT AV Drug Coated Balloon.

IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

PTA will be performed using a commercially available uncoated PTA balloon.

Standard Balloon Angioplasty: Standard PTA Balloon

Overall Number of Participants Analyzed 170 160
Measure Type: Count of Participants
Unit of Measure: Participants
Access Circuit Thromboses Within 3 Months Number Analyzed 160 participants 155 participants
2
   1.3%
1
   0.6%
Access Circuit Thromboses Within 6 Months Number Analyzed 151 participants 146 participants
3
   2.0%
5
   3.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IN.PACT AV DCB, Standard Balloon Angioplasty
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.222
Comments There is no planned test for 3 Month endpoint, therefore no p-value at 3 Months. P-value listed is at 6 Months.
Method Chi-squared
Comments [Not Specified]
9.Secondary Outcome
Title Device Success
Hide Description Device Success is defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst at or below rated burst pressure (RBP) during the index procedure.
Time Frame Time of Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IN.PACT AV DCB Standard Balloon Angioplasty
Hide Arm/Group Description:

PTA will be performed using the IN.PACT AV Drug Coated Balloon.

IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

PTA will be performed using a commercially available uncoated PTA balloon.

Standard Balloon Angioplasty: Standard PTA Balloon

Overall Number of Participants Analyzed 170 160
Overall Number of Units Analyzed
Type of Units Analyzed: Devices used
212 162
Measure Type: Number
Unit of Measure: Devices successfully used
212 162
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IN.PACT AV DCB, Standard Balloon Angioplasty
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.999
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
10.Secondary Outcome
Title Procedure Success
Hide Description Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).
Time Frame Time of Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IN.PACT AV DCB Standard Balloon Angioplasty
Hide Arm/Group Description:

PTA will be performed using the IN.PACT AV Drug Coated Balloon.

IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

PTA will be performed using a commercially available uncoated PTA balloon.

Standard Balloon Angioplasty: Standard PTA Balloon

Overall Number of Participants Analyzed 170 160
Measure Type: Count of Participants
Unit of Measure: Participants
125
  73.5%
123
  76.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IN.PACT AV DCB, Standard Balloon Angioplasty
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.482
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
11.Secondary Outcome
Title Clinical Success
Hide Description Resumption of successful dialysis for at least one session after index procedure.
Time Frame From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IN.PACT AV DCB Standard Balloon Angioplasty
Hide Arm/Group Description:

PTA will be performed using the IN.PACT AV Drug Coated Balloon.

IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

PTA will be performed using a commercially available uncoated PTA balloon.

Standard Balloon Angioplasty: Standard PTA Balloon

Overall Number of Participants Analyzed 159 154
Measure Type: Count of Participants
Unit of Measure: Participants
159
 100.0%
154
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IN.PACT AV DCB, Standard Balloon Angioplasty
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.999
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
12.Secondary Outcome
Title Rate of Device Related Adverse Events
Hide Description Device Related Adverse Event Rate: defined as proportion of subjects with device related Adverse Events. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.
Time Frame 30 days, 3, 6, 9, 12, 18, and 24 Months.
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Subjects with One or More Device-Related Adverse Events
Arm/Group Title IN.PACT AV DCB Standard Balloon Angioplasty
Hide Arm/Group Description:

PTA will be performed using the IN.PACT AV Drug Coated Balloon.

IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

PTA will be performed using a commercially available uncoated PTA balloon.

Standard Balloon Angioplasty: Standard PTA Balloon

Overall Number of Participants Analyzed 170 160
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects with device related AEs within 30 days
2
   1.2%
2
   1.3%
Subjects with device related AEs within 3 Months
7
   4.1%
5
   3.1%
Subjects with device related AEs within 6 Months
10
   5.9%
7
   4.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IN.PACT AV DCB, Standard Balloon Angioplasty
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.623
Comments This is the p-value at 6 Months.
Method Fisher Exact
Comments [Not Specified]
13.Secondary Outcome
Title Procedure Related Adverse Event Rate
Hide Description Procedure Related Adverse Event Rate: defined as proportion of subjects with procedure related Adverse Events reported post-index procedure until the first successful dialysis session. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.
Time Frame 30 Days, 3, 6, 9, 12, 18, and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Subjects with One or More Procedure-Related Adverse Events
Arm/Group Title IN.PACT AV DCB Standard Balloon Angioplasty
Hide Arm/Group Description:

PTA will be performed using the IN.PACT AV Drug Coated Balloon.

IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

PTA will be performed using a commercially available uncoated PTA balloon.

Standard Balloon Angioplasty: Standard PTA Balloon

Overall Number of Participants Analyzed 170 160
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects with Procedure-Related AEs within 30 Days
7
   4.1%
7
   4.4%
Subjects with Procedure-Related AEs within 3 Month
7
   4.1%
7
   4.4%
Subjects with Procedure-Related AEs within 6 Month
7
   4.1%
7
   4.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IN.PACT AV DCB, Standard Balloon Angioplasty
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments P-value is at 6 Months.
Method Fisher Exact
Comments [Not Specified]
Time Frame All Adverse Events were collected from the time of consent through the 6 Months post procedure. After 6 months, only Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), Severe Adverse Device Effects (SADEs), and Unanticipated Adverse Device Effects (UADEs) will be collected. Adverse Event data is listed through 6 months and mortality data is listed through 12 months. Additional adverse event and mortality results will be reported when collection and analysis is completed.
Adverse Event Reporting Description Adverse Event data is reported to the 6 Month primary endpoint.
 
Arm/Group Title IN.PACT AV DCB Standard Balloon Angioplasty
Hide Arm/Group Description

PTA will be performed using the IN.PACT AV Drug Coated Balloon.

IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

PTA will be performed using a commercially available uncoated PTA balloon.

Standard Balloon Angioplasty: Standard PTA Balloon

All-Cause Mortality
IN.PACT AV DCB Standard Balloon Angioplasty
Affected / at Risk (%) Affected / at Risk (%)
Total   15/170 (8.82%)      14/160 (8.75%)    
Hide Serious Adverse Events
IN.PACT AV DCB Standard Balloon Angioplasty
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   71/170 (41.76%)      85/160 (53.13%)    
Blood and lymphatic system disorders     
Leukocytosis  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Thrombocytopenia  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Cardiac disorders     
Acute Coronary Syndrome  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Angina Pectoris  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Aortic Valve Stenosis  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Atrial Fibrillation  1  4/170 (2.35%)  4 1/160 (0.63%)  1
Bradycardia  1  1/170 (0.59%)  1 1/160 (0.63%)  1
Cardiac Arrest  1  2/170 (1.18%)  2 0/160 (0.00%)  0
Cardiac Failure Congestive  1  1/170 (0.59%)  1 4/160 (2.50%)  4
Coronary Artery Disease  1  1/170 (0.59%)  1 2/160 (1.25%)  2
Coronary Artery Occlusion  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Coronary Artery Stenosis  1  2/170 (1.18%)  2 2/160 (1.25%)  2
Diastolic Dysfunction  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Mitral Valve Incompetence  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Pericardial Effusion  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Eye disorders     
Cataract  1  2/170 (1.18%)  4 0/160 (0.00%)  0
Vitreous Haemorrhage  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Gastrointestinal disorders     
Ascites  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Colitis Ischaemic  1  1/170 (0.59%)  3 0/160 (0.00%)  0
Diarrhoea  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Diverticulum  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Dysphagia  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Gastric Polyps  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Gastrointestinal Haemorrhage  1  2/170 (1.18%)  2 2/160 (1.25%)  2
Mesenteric Haematoma  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Nausea  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Pancreatitis Acute  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Upper Gastrointestinal Haemorrhage  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Vomiting  1  1/170 (0.59%)  1 0/160 (0.00%)  0
General disorders     
Chest Pain  1  2/170 (1.18%)  2 1/160 (0.63%)  1
Death  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Hepatobiliary disorders     
Bile Duct Stone  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Cholelithiasis  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Hepatic Cirrhosis  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Portal Vein Thrombosis  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Immune system disorders     
Kidney Transplant Rejection  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Infections and infestations     
Abdominal Abscess  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Appendicitis  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Bronchitis  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Cellulitis  1  1/170 (0.59%)  1 1/160 (0.63%)  1
Clostridium Difficile Colitis  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Endocarditis  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Enterococcal Infection  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Escherichia Bacteraemia  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Gastroenteritis  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Gastrointestinal Infection  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Infected Skin Ulcer  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Osteomyelitis  1  1/170 (0.59%)  2 0/160 (0.00%)  0
Pneumonia  1  7/170 (4.12%)  8 1/160 (0.63%)  1
Pyelonephritis  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Sepsis  1  3/170 (1.76%)  3 2/160 (1.25%)  2
Septic Shock  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Staphylococcal Bacteraemia  1  1/170 (0.59%)  1 1/160 (0.63%)  1
Subcutaneous Abscess  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Urinary Tract Infection  1  0/170 (0.00%)  0 1/160 (0.63%)  2
Injury, poisoning and procedural complications     
Acetabulum Fracture  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Arteriovenous Fistula Aneurysm  1  2/170 (1.18%)  2 3/160 (1.88%)  3
Arteriovenous Fistula Occlusion  1  2/170 (1.18%)  2 1/160 (0.63%)  1
Arteriovenous Fistula Site Complication  1  32/170 (18.82%)  51 57/160 (35.63%)  76
Arteriovenous Fistula Site Haemorrhage  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Arteriovenous Fistula Thrombosis  1  1/170 (0.59%)  1 2/160 (1.25%)  3
Coronary Artery Restenosis  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Dialysis Related Complication  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Femur Fracture  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Haemodialysis Complication  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Hip Fracture  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Limb Injury  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Multiple Fractures  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Rectal Injury  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Skull Fracture  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Spinal Compression Fracture  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Subdural Haematoma  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Investigations     
Troponin Increased  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Metabolism and nutrition disorders     
Fluid Overload  1  3/170 (1.76%)  3 1/160 (0.63%)  1
Hyperglycaemia  1  1/170 (0.59%)  1 1/160 (0.63%)  1
Hyperkalaemia  1  1/170 (0.59%)  1 3/160 (1.88%)  3
Hypernatraemia  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Hypervolaemia  1  1/170 (0.59%)  1 1/160 (0.63%)  1
Malnutrition  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis Reactive  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Back Pain  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Chondrocalcinosis Pyrophosphate  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Costochondritis  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Flank Pain  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Spinal Column Stenosis  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder Cancer  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Breast Angiosarcoma  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Lung Adenocarcinoma  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Metastases To Peritoneum  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Prostate Cancer Metastatic  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Nervous system disorders     
Carotid Artery Stenosis  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Cerebrovascular Accident  1  2/170 (1.18%)  3 0/160 (0.00%)  0
Cervical Radiculopathy  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Encephalopathy  1  1/170 (0.59%)  1 1/160 (0.63%)  1
Hepatic Encephalopathy  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Ischaemic Stroke  1  1/170 (0.59%)  1 1/160 (0.63%)  1
Neuropathy Peripheral  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Presyncope  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Syncope  1  0/170 (0.00%)  0 1/160 (0.63%)  2
Transient Ischaemic Attack  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Psychiatric disorders     
Delirium Tremens  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Mental Status Changes  1  0/170 (0.00%)  0 2/160 (1.25%)  2
Renal and urinary disorders     
End Stage Renal Disease  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Renal Cyst  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Renal Mass  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Urinary Retention  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure  1  2/170 (1.18%)  2 0/160 (0.00%)  0
Chronic Obstructive Pulmonary Disease  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Dyspnoea Exertional  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Hypoxia  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Pleural Effusion  1  5/170 (2.94%)  6 0/160 (0.00%)  0
Pneumonia Aspiration  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Pulmonary Hypertension  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Pulmonary Oedema  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Respiratory Arrest  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Respiratory Failure  1  1/170 (0.59%)  1 1/160 (0.63%)  1
Skin and subcutaneous tissue disorders     
Diabetic Foot  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Social circumstances     
Refusal Of Treatment By Patient  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Surgical and medical procedures     
Arteriovenous Fistula Operation  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Vascular disorders     
Aortic Aneurysm  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Aortic Stenosis  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Hypotension  1  2/170 (1.18%)  2 2/160 (1.25%)  2
Peripheral Arterial Occlusive Disease  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Peripheral Artery Occlusion  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Peripheral Artery Stenosis  1  0/170 (0.00%)  0 1/160 (0.63%)  1
Peripheral Ischaemia  1  1/170 (0.59%)  1 0/160 (0.00%)  0
Steal Syndrome  1  0/170 (0.00%)  0 3/160 (1.88%)  3
Venous Stenosis  1  0/170 (0.00%)  0 1/160 (0.63%)  1
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IN.PACT AV DCB Standard Balloon Angioplasty
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/170 (5.29%)      15/160 (9.38%)    
Injury, poisoning and procedural complications     
Arteriovenous Fistula Site Complication  1  9/170 (5.29%)  11 15/160 (9.38%)  26
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephanie Cihlar, Clinical Study Manager
Organization: Medtronic
Phone: 763.398.7932
EMail: stephanie.a.cihlar@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT03041467    
Other Study ID Numbers: APV-IN.PACT AV Access
First Submitted: February 1, 2017
First Posted: February 2, 2017
Results First Submitted: December 6, 2019
Results First Posted: February 27, 2020
Last Update Posted: February 27, 2020