Renal Stent Placement for the Treatment of Renal Artery Stenosis in Patients With Resistant Hypertension (ARTISAN)

• ClinicalTrials.gov Identifier: NCT01673373
• Recruitment Status: Completed
• First Posted: August 28, 2012
• Results First Posted: August 13, 2019
• Last Update Posted: November 20, 2020
• Sponsor: Atrium Medical Corporation
• Information provided by (Responsible Party): Atrium Medical Corporation

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Renal Artery Stenosis; Hypertension, Renovascular
• Intervention: Device: iCAST™ Rx Stent System
• Enrollment: 68

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	iCAST™ RX Stent System
Arm/Group Description	All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Period Title: Overall Study
Started	68
Completed	66 [1]
Not Completed	2
Reason Not Completed
Death	2
[1] Completed primary endpoint follow up.

Baseline Characteristics

Arm/Group Title		iCAST™ RX Stent System
Arm/Group Description		All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Overall Number of Baseline Participants		68
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	68 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	16 23.5%
	>=65 years	52 76.5%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	68 participants
		71.7 (10.17)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	68 participants
	Female	35 51.5%
	Male	33 48.5%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	68 participants
	Hispanic or Latino	6 8.8%
	Not Hispanic or Latino	62 91.2%
	Unknown or Not Reported	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	68 participants
	American Indian or Alaska Native	1 1.5%
	Asian	7 10.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	4 5.9%
	White	53 77.9%
	More than one race	3 4.4%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	68 participants
		68 100.0%
Number of Qualifying Lesions; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	68 participants
Unilateral		54 79.4%
Bilateral		14 20.6%
Systolic Blood Pressure; Mean (Standard Deviation); Unit of measure: mmHg
	Number Analyzed	68 participants
		166.2 (12.19)

Outcome Measures

1. Primary Outcome

Title	Primary Patency
Description	Primary patency rate at 9 months was defined as continuous patency without the occurrence of a total occlusion of the original lesion, without a re-intervention to treat a partial or total occlusion of the stented segment, or bypass of the stented segment due to clinically-driven restenosis or occlusion.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Subset of enrolled subjects with available duplex ultrasound or angiography assessment within the 9-month visit window.

Arm/Group Title	iCAST™ RX Stent System
Arm/Group Description:	All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Overall Number of Participants Analyzed	56
Overall Number of Units Analyzed; Type of Units Analyzed: Subject-lesions	70
Count of Units; Unit of Measure: Subject-lesions
	66 94.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	iCAST™ RX Stent System
	Comments	The original Performance Goal of 70% patency rate was derived from a thorough literature review of trials with renal bare metal stent placement. Other assumptions included a determination of samples size based upon a one-sided alpha of 0.025 and desired power of 87%, and assumption of 10% attrition. The null hypothesis was that the incidence of primary patency at 9 months is less than or equal to 70%.
	Type of Statistical Test	Other
	Comments	Due to the early termination of enrollment, all inferential analyses were interpreted as descriptive and carried out in an exploratory manner.
Statistical Test of Hypothesis	P-Value	<.0001
	Comments	The p-value was computed using a one-sided exact test of the difference between the observed rate and the Performance Goal (equal to 70%). The defined threshold for statistical significance is .025.
	Method	one-sided exact
	Comments	[Not Specified]
Other Statistical Analysis		The cumulative incidence of primary patency was computed as the number of subject-lesions with primary patency at 9 months divided by the number of subject-lesions and was analyzed using the allowable window of 243 to 303 trial days. An exact binomial one-sided 95% CI was constructed and the lower limit compared to the Performance Goal equal to 70%.

2. Primary Outcome

Title	Systolic Blood Pressure
Description	Change in systolic blood pressure (SBP) at 9 months as compared to baseline SBP.
Time Frame	Baseline and 9 months

Outcome Measure Data

Analysis Population Description

Subset of enrolled subjects with available blood pressure data at baseline and 9 months.

Arm/Group Title	iCAST™ RX Stent System
Arm/Group Description:	All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Overall Number of Participants Analyzed	63
Mean (Standard Deviation); Unit of Measure: mmHg
	15.7 (21.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	iCAST™ RX Stent System
	Comments	The primary endpoint of systolic blood pressure was analyzed according to the Performance Goal of a decrease in systolic blood pressure of 10 mmHg between procedure and 9 months.
	Type of Statistical Test	Other
	Comments	A one-sided 95% Confidence Interval for the mean difference between baseline and 9-month systolic blood pressure was constructed and the lower limit compared to the 10 mmHg performance goal. A p-value of the difference between the estimated systolic blood pressure change from the baseline and the performance goal was computed using a paired t-test.
Statistical Test of Hypothesis	P-Value	.0192
	Comments	The defined threshold for statistical significance is .025.
	Method	t-test, 1 sided
	Comments	[Not Specified]

3. Secondary Outcome

Title	Procedure-Related Major Adverse Events (MAE)
Description	The occurence of procedure-related MAEs is reported as a percentage of subjects with MAE. Inclusive of: Procedure- or device-related occurrence of death; Q-Wave myocardial infarction (MI); Clinically driven target lesion revascularization (TLR); Significant embolic events defined as unanticipated kidney/bowel infarct, clinically driven by symptoms of abdominal or back pain and confirmed with CT scan or open surgery; lower extremity ulceration or gangrene; or kidney failure.
Time Frame	30 days, 9 months

Outcome Measure Data

Analysis Population Description

All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.

Arm/Group Title	iCAST™ RX Stent System
Arm/Group Description:	All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Overall Number of Participants Analyzed	68
Measure Type: Count of Participants; Unit of Measure: Participants
Overall subjects experiencing MAE	5 7.4%
MAE within 30 days	0 0.0%
MAE within 9 months	2 2.9%

4. Secondary Outcome

Title	Technical Success
Description	Technical success is defined as successful delivery and deployment of the iCAST™ RX Stent System with ≤ 30% residual angiographic stenosis after covered stent deployment (including post-dilatation) assessed via quantitative vascular analysis (QVA) by an independent core laboratory.
Time Frame	Day of Procedure

Outcome Measure Data

Analysis Population Description

All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion with available angiography.

Arm/Group Title	iCAST™ RX Stent System
Arm/Group Description:	All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Overall Number of Participants Analyzed	68
Overall Number of Units Analyzed; Type of Units Analyzed: Subject-lesions	81
Count of Units; Unit of Measure: Subject-lesions
	81 100.0%

5. Secondary Outcome

Title	Acute Procedural Success
Description	Acute procedural success is defined as technical success without the occurrence of MAE prior to hospital discharge.
Time Frame	Day of Procedure, prior to hospital discharge

Outcome Measure Data

Analysis Population Description

All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion with available angiography.

Arm/Group Title	iCAST™ RX Stent System
Arm/Group Description:	All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Overall Number of Participants Analyzed	68
Overall Number of Units Analyzed; Type of Units Analyzed: Subject-lesions	81
Count of Units; Unit of Measure: Subject-lesions
	81 100.0%

6. Secondary Outcome

Title	Target Lesion Revascularization (TLR)
Description	Target Lesion Revascularization (TLR) is measured as the proportion of subjects-lesions that require a clinically-driven reintervention of the target lesion through 9 months. a. A clinically-driven TLR is defined as a TLR (percutaneous balloon angioplasty (PTA), bare metal stent or repeat covered stent deployment, or surgical bypass) due to documented recurrent hypertension from 30-days post-procedure level and/or deterioration in renal function from baseline value, associated with angiographic core laboratory adjudication of a ≥ 60% diameter covered stent restenosis.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion.

Arm/Group Title	iCAST™ RX Stent System
Arm/Group Description:	All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Overall Number of Participants Analyzed	68
Overall Number of Units Analyzed; Type of Units Analyzed: Subject-lesions	82
Count of Units; Unit of Measure: Subject-lesions
	3 3.7%

7. Secondary Outcome

Title	Rate of Incidental TLR
Description	The rate of incidental TLR is the rate of TLRs not meeting the definition of a clinically-driven TLR.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion.

Arm/Group Title	iCAST™ RX Stent System
Arm/Group Description:	All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Overall Number of Participants Analyzed	68
Overall Number of Units Analyzed; Type of Units Analyzed: Subject-lesions	82
Count of Units; Unit of Measure: Subject-lesions
	2 2.4%

8. Secondary Outcome

Title	Systolic Blood Pressure (SBP) Control
Description	The change in SBP from baseline to 30 days
Time Frame	Baseline and 30 days

Outcome Measure Data

Analysis Population Description

Subset of enrolled subjects with available blood pressure measurements at both time points.

Arm/Group Title	iCAST™ RX Stent System
Arm/Group Description:	All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Overall Number of Participants Analyzed	67
Mean (Standard Deviation); Unit of Measure: mmHg
	-13.6 (18.83)

9. Secondary Outcome

Title	SBP Control
Description	The change in SBP from baseline to 9 months
Time Frame	Baseline and 9 months

Outcome Measure Data

Analysis Population Description

Subset of enrolled subjects with available blood pressure measurements at both time points.

Arm/Group Title	iCAST™ RX Stent System
Arm/Group Description:	All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Overall Number of Participants Analyzed	63
Mean (Standard Deviation); Unit of Measure: mmHg
	-15.7 (21.20)

10. Secondary Outcome

Title	Secondary Patency Rate
Description	Secondary patency rate at 9 months after a clinically-driven TLR which restores patency after total occlusion.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion.

Arm/Group Title	iCAST™ RX Stent System
Arm/Group Description:	All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Overall Number of Participants Analyzed	68
Overall Number of Units Analyzed; Type of Units Analyzed: Subject-lesions	82
Count of Units; Unit of Measure: Subject-lesions
	3 3.7%

11. Secondary Outcome

Title	Change in Number of Anti-Hypertensive Medications
Description	Change in number of anti-hypertensive medications as compared to baseline.
Time Frame	Baseline and 9 months

Outcome Measure Data

Analysis Population Description

Subset of enrolled subjects with available medication information.

Arm/Group Title	iCAST™ RX Stent System
Arm/Group Description:	All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Overall Number of Participants Analyzed	63
Mean (Standard Deviation); Unit of Measure: Number of Anti-hypertensive Medications
	-0.1 (0.76)

12. Secondary Outcome

Title	Change in Renal Function
Description	Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 30 days.
Time Frame	Baseline and 30 days

Outcome Measure Data

Analysis Population Description

Subset of enrolled subjects with available eGFR measurements.

Arm/Group Title	iCAST™ RX Stent System
Arm/Group Description:	All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Overall Number of Participants Analyzed	67
Mean (Standard Deviation); Unit of Measure: eGFR mL/min/1.73 m^2
	-0.5520 (8.42795)

13. Secondary Outcome

Title	Change in Renal Function
Description	Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 9 months.
Time Frame	Baseline and 9 months

Outcome Measure Data

Analysis Population Description

Subset of enrolled subjects with available eGFR measurements.

Arm/Group Title	iCAST™ RX Stent System
Arm/Group Description:	All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Overall Number of Participants Analyzed	65
Mean (Standard Deviation); Unit of Measure: eGFR mL/min/1.73 m^2
	-1.9964 (13.42781)

Adverse Events

Time Frame	Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years.
Adverse Event Reporting Description	Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Arm/Group Title	iCAST™ RX Stent System
Arm/Group Description	All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
All-Cause Mortality
	iCAST™ RX Stent System
	Affected / at Risk (%)
Total	4/68 (5.88%)
Serious Adverse Events
	iCAST™ RX Stent System
	Affected / at Risk (%)	# Events
Total	40/68 (58.82%)
Blood and lymphatic system disorders
Anaemia * 1	3/68 (4.41%)	3
Iron deficiency anaemia * 1	1/68 (1.47%)	1
Normochromic normocytic anaemia * 1	1/68 (1.47%)	1
Cardiac disorders
Angina pectoris * 1	7/68 (10.29%)	7
Arrhythmia * 1	5/68 (7.35%)	5
Atrial fibrillation * 1	1/68 (1.47%)	1
Bradycardia * 1	1/68 (1.47%)	1
Cardiac arrest * 1	1/68 (1.47%)	1
Cardiac failure congestive * 1	6/68 (8.82%)	6
Cardiomyopathy * 1	1/68 (1.47%)	1
Coronary artery stenosis * 1	1/68 (1.47%)	1
Myocardial infarction * 1	2/68 (2.94%)	2
Pericardial effusion * 1	1/68 (1.47%)	1
Endocrine disorders
Adrenal insufficiency * 1	1/68 (1.47%)	1
Gastrointestinal disorders
Diarrhoea * 1	1/68 (1.47%)	1
Gastrointestinal haemorrhage * 1	1/68 (1.47%)	1
Gastrointestinal necrosis * 1	1/68 (1.47%)	1
Mesenteric artery stenosis * 1	1/68 (1.47%)	1
Oesophageal spasm * 1	1/68 (1.47%)	1
Pancreatitis * 1	1/68 (1.47%)	1
Small intestinal obstruction * 1	1/68 (1.47%)	1
General disorders
Chest pain * 1	1/68 (1.47%)	1
Device occlusion * 1	1/68 (1.47%)	1
Non-cardiac chest pain * 1	1/68 (1.47%)	1
Infections and infestations
Appendicitis * 1	1/68 (1.47%)	1
Bronchitis * 1	1/68 (1.47%)	1
Gastroenteritis * 1	1/68 (1.47%)	1
Pneumonia * 1	6/68 (8.82%)	6
Urinary tract infection * 1	2/68 (2.94%)	2
Injury, poisoning and procedural complications
Arterial restenosis * 1	8/68 (11.76%)	9
Concussion * 1	1/68 (1.47%)	1
Fall * 1	1/68 (1.47%)	1
Hip fracture * 1	1/68 (1.47%)	1
Spinal compression fracture * 1	1/68 (1.47%)	1
Metabolism and nutrition disorders
Dehydration * 1	1/68 (1.47%)	1
Musculoskeletal and connective tissue disorders
Musculoskeletal pain * 1	1/68 (1.47%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer * 1	1/68 (1.47%)	1
Lung cancer metastatic * 1	1/68 (1.47%)	1
Skin cancer * 1	1/68 (1.47%)	1
Nervous system disorders
Carotid artery stenosis * 1	1/68 (1.47%)	1
Cerebrovascular accident * 1	4/68 (5.88%)	4
Psychiatric disorders
Depression * 1	1/68 (1.47%)	1
Renal and urinary disorders
Glomerulonephritis * 1	1/68 (1.47%)	1
Hydronephrosis * 1	1/68 (1.47%)	1
Nephrolithiasis * 1	1/68 (1.47%)	1
Renal failure acute * 1	2/68 (2.94%)	2
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease * 1	1/68 (1.47%)	5
Dyspnoea * 1	1/68 (1.47%)	1
Pulmonary embolism * 1	1/68 (1.47%)	1
Respiratory failure * 1	1/68 (1.47%)	1
Skin and subcutaneous tissue disorders
Skin ulcer * 1	1/68 (1.47%)	1
Vascular disorders
Brachiocephalic artery occlusion * 1	1/68 (1.47%)	1
Hypertension * 1	1/68 (1.47%)	1
Hypertensive emergency * 1	1/68 (1.47%)	1
Hypovolaemic shock * 1	1/68 (1.47%)	1
Iliac artery stenosis * 1	2/68 (2.94%)	2
Intermittent claudication * 1	2/68 (2.94%)	2
Malignant hypertension * 1	1/68 (1.47%)	1
Peripheral arterial occlusive disease * 1	2/68 (2.94%)	2
Peripheral vascular disorder * 1	2/68 (2.94%)	2
Subclavian artery aneurysm * 1	1/68 (1.47%)	1
1 Term from vocabulary, MedDRA (15.0); * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	iCAST™ RX Stent System
	Affected / at Risk (%)	# Events
Total	12/68 (17.65%)
Blood and lymphatic system disorders
Anaemia * 1	4/68 (5.88%)	4
Injury, poisoning and procedural complications
Subcutaneous haematoma * 1	4/68 (5.88%)	4
Respiratory, thoracic and mediastinal disorders
Dyspnoea * 1	5/68 (7.35%)	6
1 Term from vocabulary, MedDRA (15.0); * Indicates events were collected by non-systematic assessment

Limitations and Caveats

The limitation of the study was the termination of enrollment due to the change in clinical practice.

More Information

Certain Agreements

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

There is NOT 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

• Name/Title: Sr. Clinical Trial Manager
• Organization: Getinge
• Phone: 603-864-5219
• EMail: inka.vesela@getinge.com

• Responsible Party: Atrium Medical Corporation
• ClinicalTrials.gov Identifier: NCT01673373
• Other Study ID Numbers: iCAST™ RX-ARAS-001
• First Submitted: August 23, 2012
• First Posted: August 28, 2012
• Results First Submitted: June 27, 2019
• Results First Posted: August 13, 2019
• Last Update Posted: November 20, 2020