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Atrium iCAST Iliac Stent Pivotal Study (iCARUS)

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ClinicalTrials.gov Identifier: NCT00593385
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
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
Condition Peripheral Vascular Disease
Intervention Device: iCAST covered stent
Enrollment 165
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description Implantation of ≥ 1 ICAST stent
Period Title: Overall Study
Started 165
Intention to Treat (ITT) Population [1] 152 [2]
Completed 125 [3]
Not Completed 40
Reason Not Completed
Death             14
Lost to Follow-up             17
Withdrawal by Subject             9
[1]
Subjects who signed written informed consent, enrolled in the study and met study entry criteria.
[2]
Excludes 13 subjects who did not meet inclusion/exclusion criteria.
[3]
125 of 165 enrolled patients completed the study.
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description Implantation of ≥ 1 ICAST stent
Overall Number of Baseline Participants 152
Hide Baseline Analysis Population Description
ITT population was assessed for baseline measures: this includes subjects who signed the written informed consent, enrolled in the study and met the study entry criteria.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 152 participants
65.23  (9.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants
Female
58
  38.2%
Male
94
  61.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants
Hispanic or Latino
3
   2.0%
Not Hispanic or Latino
149
  98.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
   5.3%
White
142
  93.4%
More than one race
2
   1.3%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 152 participants
132
Germany Number Analyzed 152 participants
20
Cigarette Smoking Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
Current smoker
76
  50.3%
Former smoker
62
  41.1%
Non-smoker
13
   8.6%
Unknown
0
   0.0%
[1]
Measure Analysis Population Description: One subject was missing data.
Previous Peripheral Artery Revascularization/Surgery   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
25
  16.7%
[1]
Measure Analysis Population Description: Two subjects were missing data.
Coronary Artery Disease   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
77
  51.0%
[1]
Measure Analysis Population Description: One subject was missing data.
Previous Myocardial Infarction (MI)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
35
  23.2%
[1]
Measure Analysis Population Description: One subject was missing data.
Previous percutaneous coronary revascularization   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
39
  25.8%
[1]
Measure Analysis Population Description: One subject was missing data.
Coronary Artery Bypass Graft Surgery   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
34
  22.5%
[1]
Measure Analysis Population Description: One subject was missing data.
Cerebrovascular Accident  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants
11
   7.2%
Previous Amputation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants
2
   1.3%
Transient Ischemic Attack   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants
7
   4.6%
[1]
Measure Analysis Population Description: One subject was missing data.
Diabetes Mellitus  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants
56
  36.8%
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants
129
  84.9%
Hypercholesterolemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants
130
  85.5%
Renal Insufficiency  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants
19
  12.5%
1.Primary Outcome
Title Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis
Hide Description The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization within 9 months or restenosis (by ultrasound determination) at 9 months.
Time Frame Within 9 Months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: Subjects who signed the written informed consent, enrolled in the study and met the study entry criteria.
Arm/Group Title iCAST Covered Stent
Hide Arm/Group Description:

Device: iCAST covered stent

Implantation of ≥1 iCAST stents

Overall Number of Participants Analyzed 152
Measure Type: Number
Unit of Measure: Percentage of subjects
8.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection iCAST Covered Stent
Comments The composite event rate to determine the performance metric of 16.57% was based on a meta-analysis performed on data from 3 previous studies(9.67%). A 6.9% margin was deemed acceptable at the time of study design. Rejection of the null hypothesis requires that the iCAST Covered Stent primary endpoint rate was significantly below 16.57%. Other assumptions for the analysis included a power of 80% and one-sided alpha error of 5%.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments An exact one sided upper 95% confidence interval of the primary endpoint rate was calculated based on primary analysis population.
Method Exact test of the binomial distribution
Comments [Not Specified]
Method of Estimation Estimation Parameter Meta-Analysis
Estimated Value 9.67
Confidence Interval (1-Sided) 95%
16.57
Estimation Comments To estimate primary endpoint rate, a meta-analysis was performed on data from 3 previous studies. The meta-analytical rate derived was 9.67%
2.Secondary Outcome
Title Acute Procedural Success
Hide Description Device success and achievement of < 30% residual stenosis immediately after stent placement and without occurrence of in-hospital MAVE.
Time Frame Post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 151
Measure Type: Count of Participants
Unit of Measure: Participants
140
  92.7%
3.Secondary Outcome
Title Device Success
Hide Description Successful delivery and deployment of the study stent and intact retrieval of the delivery system.
Time Frame Post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: Subjects who signed the written informed consent, enrolled in the study and met the study entry criteria.
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 152
Measure Type: Count of Participants
Unit of Measure: Participants
150
  98.7%
4.Secondary Outcome
Title Major Adverse Event (MAE)
Hide Description Composite rate of MAVE or any death, or stroke.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 151
Measure Type: Count of Participants
Unit of Measure: Participants
8
   5.3%
5.Secondary Outcome
Title Major Adverse Vascular Event (MAVE)
Hide Description Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 151
Measure Type: Count of Participants
Unit of Measure: Participants
7
   4.6%
6.Secondary Outcome
Title Major Adverse Vascular Event (MAVE)
Hide Description Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.
Time Frame 180 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 144
Measure Type: Count of Participants
Unit of Measure: Participants
10
   6.9%
7.Secondary Outcome
Title Major Adverse Vascular Event (MAVE)
Hide Description Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.
Time Frame 270 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 140
Measure Type: Count of Participants
Unit of Measure: Participants
10
   7.1%
8.Secondary Outcome
Title Major Adverse Vascular Event (MAVE)
Hide Description Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.
Time Frame 360 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 139
Measure Type: Count of Participants
Unit of Measure: Participants
10
   7.2%
9.Secondary Outcome
Title Early Clinical Success
Hide Description Improvement of the Rutherford-Becker clinical criteria by ≥ 1 category. (Classification system for evaluating clinical improvement as defined by Rutherford R, Becker G. Standards for evaluating and reporting the results of surgical and percutaneous therapy for peripheral arterial disease. Journal of Vascular Interventional Radiology 1991;2:169-174.)
Time Frame 1 Month
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 150
Measure Type: Count of Participants
Unit of Measure: Participants
133
  88.7%
10.Secondary Outcome
Title Late Clinical Success
Hide Description Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 126
Measure Type: Count of Participants
Unit of Measure: Participants
80
  63.5%
11.Secondary Outcome
Title Late Clinical Success
Hide Description Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.
Time Frame 9 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 128
Measure Type: Count of Participants
Unit of Measure: Participants
98
  76.6%
12.Secondary Outcome
Title Late Clinical Success
Hide Description Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 128
Measure Type: Count of Participants
Unit of Measure: Participants
86
  67.2%
13.Secondary Outcome
Title Late Clinical Success
Hide Description Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 113
Measure Type: Count of Participants
Unit of Measure: Participants
80
  70.8%
14.Secondary Outcome
Title Late Clinical Success
Hide Description Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.
Time Frame 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 105
Measure Type: Count of Participants
Unit of Measure: Participants
76
  72.4%
15.Secondary Outcome
Title Primary Patency
Hide Description Continuous flow without revascularization, bypass or target limb amputation.
Time Frame 1 Month
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 151
Measure Type: Count of Participants
Unit of Measure: Participants
151
 100.0%
16.Secondary Outcome
Title Primary Patency
Hide Description Continuous flow without revascularization, bypass or target limb amputation.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 144
Measure Type: Count of Participants
Unit of Measure: Participants
143
  99.3%
17.Secondary Outcome
Title Primary Patency
Hide Description Continuous flow without revascularization, bypass or target limb amputation.
Time Frame 9 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 139
Measure Type: Count of Participants
Unit of Measure: Participants
134
  96.4%
18.Secondary Outcome
Title Primary Patency
Hide Description Continuous flow without revascularization, bypass or target limb amputation.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 138
Measure Type: Count of Participants
Unit of Measure: Participants
129
  93.5%
19.Secondary Outcome
Title Primary Patency
Hide Description Continuous flow without revascularization, bypass or target limb amputation.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 129
Measure Type: Count of Participants
Unit of Measure: Participants
113
  87.6%
20.Secondary Outcome
Title Primary Patency
Hide Description Continuous flow without revascularization, bypass or target limb amputation.
Time Frame 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 118
Measure Type: Count of Participants
Unit of Measure: Participants
100
  84.7%
21.Secondary Outcome
Title Primary-Assisted Patency
Hide Description Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Time Frame 1 Month
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥1 ICAST stent
Overall Number of Participants Analyzed 151
Measure Type: Count of Participants
Unit of Measure: Participants
151
 100.0%
22.Secondary Outcome
Title Primary-Assisted Patency
Hide Description Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥1 ICAST stent
Overall Number of Participants Analyzed 144
Measure Type: Count of Participants
Unit of Measure: Participants
144
 100.0%
23.Secondary Outcome
Title Primary-Assisted Patency
Hide Description Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Time Frame 9 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥1 ICAST stent
Overall Number of Participants Analyzed 139
Measure Type: Count of Participants
Unit of Measure: Participants
139
 100.0%
24.Secondary Outcome
Title Primary-Assisted Patency
Hide Description Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥ 1 ICAST stent
Overall Number of Participants Analyzed 138
Measure Type: Count of Participants
Unit of Measure: Participants
138
 100.0%
25.Secondary Outcome
Title Primary-Assisted Patency
Hide Description Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥1 ICAST stent
Overall Number of Participants Analyzed 129
Measure Type: Count of Participants
Unit of Measure: Participants
128
  99.2%
26.Secondary Outcome
Title Primary-Assisted Patency
Hide Description Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Time Frame 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥1 ICAST stent
Overall Number of Participants Analyzed 115
Measure Type: Count of Participants
Unit of Measure: Participants
114
  99.1%
27.Secondary Outcome
Title Secondary Patency
Hide Description Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Time Frame 1 Month
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥1 ICAST stent
Overall Number of Participants Analyzed 151
Measure Type: Count of Participants
Unit of Measure: Participants
151
 100.0%
28.Secondary Outcome
Title Secondary Patency
Hide Description Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥1 ICAST stent
Overall Number of Participants Analyzed 144
Measure Type: Count of Participants
Unit of Measure: Participants
144
 100.0%
29.Secondary Outcome
Title Secondary Patency
Hide Description Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Time Frame 9 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥1 ICAST stent
Overall Number of Participants Analyzed 139
Measure Type: Count of Participants
Unit of Measure: Participants
139
 100.0%
30.Secondary Outcome
Title Secondary Patency
Hide Description Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥1 ICAST stent
Overall Number of Participants Analyzed 138
Measure Type: Count of Participants
Unit of Measure: Participants
138
 100.0%
31.Secondary Outcome
Title Secondary Patency
Hide Description Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥1 ICAST stent
Overall Number of Participants Analyzed 129
Measure Type: Count of Participants
Unit of Measure: Participants
129
 100.0%
32.Secondary Outcome
Title Secondary Patency
Hide Description Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Time Frame 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description:
Implantation of ≥1 ICAST stent
Overall Number of Participants Analyzed 115
Measure Type: Count of Participants
Unit of Measure: Participants
115
 100.0%
Time Frame 1080 Days post-procedure
Adverse Event Reporting Description Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
 
Arm/Group Title Device: ICAST Covered Stent
Hide Arm/Group Description Implantation of ≥ 1 ICAST stent
All-Cause Mortality
Device: ICAST Covered Stent
Affected / at Risk (%)
Total   14/165 (8.48%)    
Hide Serious Adverse Events
Device: ICAST Covered Stent
Affected / at Risk (%) # Events
Total   86/165 (52.12%)    
Blood and lymphatic system disorders   
Anaemia * 1  2/165 (1.21%)  2
Haemorrhagic anaemia * 1  1/165 (0.61%)  1
Cardiac disorders   
Acute coronary syndrome * 1  1/165 (0.61%)  1
Acute myocardial infarction * 1  6/165 (3.64%)  8
Angina pectoris * 1  3/165 (1.82%)  5
Angina unstable * 1  3/165 (1.82%)  4
Atrial fibrillation * 1  2/165 (1.21%)  2
Atrial flutter * 1  1/165 (0.61%)  1
Atrioventricular block * 1  1/165 (0.61%)  1
Cardiac arrest * 1  1/165 (0.61%)  1
Cardiac failure * 1  1/165 (0.61%)  1
Cardiac failure congestive * 1  7/165 (4.24%)  9
Cardio-respiratory arrest * 1  1/165 (0.61%)  1
Coronary artery disease * 1  2/165 (1.21%)  2
Coronary artery occlusion * 1  1/165 (0.61%)  1
Myocardial infarction * 1  6/165 (3.64%)  6
Stress cardiomyopathy * 1  1/165 (0.61%)  1
Ventricular tachycardia * 1  1/165 (0.61%)  1
Ear and labyrinth disorders   
Vertigo * 1  1/165 (0.61%)  1
Gastrointestinal disorders   
Abdominal pain * 1  1/165 (0.61%)  1
Colitis * 1  1/165 (0.61%)  1
Gastritis * 1  1/165 (0.61%)  1
Gastrointestinal haemorrhage * 1  3/165 (1.82%)  4
Intestinal obstruction * 1  1/165 (0.61%)  1
Intestinal perforation * 1  1/165 (0.61%)  1
Nausea * 1  1/165 (0.61%)  1
Pancreatitis * 1  1/165 (0.61%)  8
Pancreatitis acute * 1  1/165 (0.61%)  3
Peritonitis * 1  1/165 (0.61%)  1
Rectal haemorrhage * 1  1/165 (0.61%)  1
Small intestinal obstruction * 1  1/165 (0.61%)  1
Upper gastrointestinal haemorrhage * 1  1/165 (0.61%)  1
Vomiting * 1  1/165 (0.61%)  1
General disorders   
Asthenia * 1  1/165 (0.61%)  1
Catheter site haematoma * 1  3/165 (1.82%)  3
Chest pain * 1  4/165 (2.42%)  5
Impaired healing * 1  1/165 (0.61%)  1
Non-cardiac chest pain * 1  1/165 (0.61%)  1
Hepatobiliary disorders   
Cholecystitis * 1  1/165 (0.61%)  1
Hepatic steatosis * 1  1/165 (0.61%)  1
Immune system disorders   
Anaphylactic reaction * 1  2/165 (1.21%)  2
Infections and infestations   
Abdominal abscess * 1  1/165 (0.61%)  1
Bronchitis * 1  1/165 (0.61%)  1
Bronchitis bacterial * 1  1/165 (0.61%)  1
Cellulitis * 1  1/165 (0.61%)  1
Gastroenteritis viral * 1  1/165 (0.61%)  1
Groin abscess * 1  1/165 (0.61%)  1
Influenza * 1  1/165 (0.61%)  1
Pneumonia * 1  8/165 (4.85%)  11
Pneumonia staphylococcal * 1  1/165 (0.61%)  1
Post procedural sepsis * 1  1/165 (0.61%)  1
Sepsis * 1  3/165 (1.82%)  3
Urosepsis * 1  1/165 (0.61%)  1
Injury, poisoning and procedural complications   
Abdominal wound dehiscence * 1  1/165 (0.61%)  2
Anaemia postoperative * 1  1/165 (0.61%)  1
Aortic injury * 1  1/165 (0.61%)  1
Arterial injury * 1  1/165 (0.61%)  1
Device dislocation * 1  1/165 (0.61%)  1
Femur fracture * 1  1/165 (0.61%)  1
In-stent arterial restenosis * 1  6/165 (3.64%)  8
Incisional hernia * 1  1/165 (0.61%)  1
Postoperative ileus * 1  1/165 (0.61%)  1
Spinal fracture * 1  1/165 (0.61%)  1
Stent occlusion * 1  1/165 (0.61%)  1
Subdural haematoma * 1  1/165 (0.61%)  1
Tendon injury * 1  1/165 (0.61%)  1
Traumatic brain injury * 1  2/165 (1.21%)  2
Urostomy complication * 1  1/165 (0.61%)  1
Vascular graft occlusion * 1  2/165 (1.21%)  2
Metabolism and nutrition disorders   
Acidosis * 1  1/165 (0.61%)  1
Fluid overload * 1  1/165 (0.61%)  1
Hyperkalaemia * 1  1/165 (0.61%)  1
Hypoglycaemia * 1  1/165 (0.61%)  1
Hyponatraemia * 1  1/165 (0.61%)  1
Obesity * 1  1/165 (0.61%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/165 (0.61%)  1
Arthritis * 1  1/165 (0.61%)  1
Fistula * 1  1/165 (0.61%)  1
Muscular weakness * 1  1/165 (0.61%)  1
Osteoarthritis * 1  1/165 (0.61%)  1
Rhabdomyolysis * 1  2/165 (1.21%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bronchial carcinoma * 1  1/165 (0.61%)  1
Colon cancer * 1  2/165 (1.21%)  2
Colon cancer recurrent * 1  1/165 (0.61%)  1
Hepatic neoplasm malignant * 1  1/165 (0.61%)  1
Lung cancer metastatic * 1  1/165 (0.61%)  1
Lung neoplasm malignant * 1  1/165 (0.61%)  1
Lymphoma * 1  1/165 (0.61%)  1
Metastases to liver * 1  1/165 (0.61%)  1
Prostate cancer * 1  1/165 (0.61%)  1
Transitional cell carcinoma * 1  1/165 (0.61%)  1
Nervous system disorders   
Brain mass * 1  1/165 (0.61%)  1
Carotid artery stenosis * 1  2/165 (1.21%)  2
Cerebrovascular accident * 1  3/165 (1.82%)  3
Encephalopathy * 1  1/165 (0.61%)  1
Polyneuropathy * 1  1/165 (0.61%)  1
Subarachnoid haemorrhage * 1  2/165 (1.21%)  2
Syncope * 1  3/165 (1.82%)  3
Syncope vasovagal * 1  1/165 (0.61%)  1
Transient ischaemic attack * 1  2/165 (1.21%)  2
Psychiatric disorders   
Depression * 1  1/165 (0.61%)  1
Renal and urinary disorders   
Calculus ureteric * 1  1/165 (0.61%)  1
Renal artery occlusion * 1  1/165 (0.61%)  1
Renal artery stenosis * 1  2/165 (1.21%)  2
Renal disorder * 1  1/165 (0.61%)  1
Renal failure * 1  1/165 (0.61%)  1
Renal failure acute * 1  5/165 (3.03%)  5
Renal failure chronic * 1  1/165 (0.61%)  1
Renal mass * 1  2/165 (1.21%)  2
Reproductive system and breast disorders   
Galactorrhoea * 1  1/165 (0.61%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure * 1  1/165 (0.61%)  3
Chronic obstructive pulmonary disease * 1  2/165 (1.21%)  3
Dyspnoea * 1  1/165 (0.61%)  1
Epistaxis * 1  1/165 (0.61%)  1
Pleural effusion * 1  1/165 (0.61%)  1
Pneumonia aspiration * 1  1/165 (0.61%)  1
Pneumothorax * 1  1/165 (0.61%)  1
Pulmonary embolism * 1  1/165 (0.61%)  1
Pulmonary mass * 1  1/165 (0.61%)  1
Pulmonary oedema * 1  1/165 (0.61%)  1
Respiratory failure * 1  2/165 (1.21%)  3
Skin and subcutaneous tissue disorders   
Psoriasis * 1  1/165 (0.61%)  1
Skin ulcer * 1  1/165 (0.61%)  1
Vascular disorders   
Aortic stenosis * 1  1/165 (0.61%)  1
Arterial restenosis * 1  2/165 (1.21%)  2
Arterial thrombosis limb * 1  1/165 (0.61%)  1
Femoral arterial stenosis * 1  5/165 (3.03%)  5
Femoral artery occlusion * 1  5/165 (3.03%)  9
Haemorrhage * 1  1/165 (0.61%)  1
Hypotension * 1  4/165 (2.42%)  4
Iliac artery stenosis * 1  7/165 (4.24%)  9
Intermittent claudication * 1  7/165 (4.24%)  9
Orthostatic hypotension * 1  1/165 (0.61%)  1
Peripheral arterial occlusive disease * 1  5/165 (3.03%)  5
Peripheral artery aneurysm * 1  1/165 (0.61%)  1
Peripheral ischaemia * 1  2/165 (1.21%)  5
Peripheral vascular disorder * 1  1/165 (0.61%)  1
Subclavian artery stenosis * 1  1/165 (0.61%)  1
Vascular pseudoaneurysm * 1  1/165 (0.61%)  1
1
Term from vocabulary, MedDRA (10.1)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Device: ICAST Covered Stent
Affected / at Risk (%) # Events
Total   22/165 (13.33%)    
Vascular disorders   
Peripheral artery dissection * 1  22/165 (13.33%)  22
1
Term from vocabulary, MedDRA (10.1)
*
Indicates events were collected by non-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.
No publication or publicizing of data or results without the Sponsor's prior written permission. Party wishing to publish or publicize will submit proposed manuscript or publication to Sponsor for comment at least 60 days prior to release. Publishing party will make every reasonable attempt to incorporate comments received from Sponsor during 60 day period.The publishing party won't use Sponsor's confidential information in manuscript or publication without the prior written consent of sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elizabeth Bulger, Director of Clinical Affairs
Organization: Getinge
Phone: 1-603-864-5368
EMail: elizabeth.bulger@getinge.com
Layout table for additonal information
Responsible Party: Atrium Medical Corporation
ClinicalTrials.gov Identifier: NCT00593385    
Other Study ID Numbers: Atrium 701
First Submitted: January 2, 2008
First Posted: January 15, 2008
Results First Submitted: February 12, 2018
Results First Posted: May 17, 2018
Last Update Posted: May 17, 2018