Peripheral Vascular Disease
Conditions
Keywords
Symptomatic claudication or rest pain and angiographic confirmation of either de novo or restenotic lesions in the common and/or external iliac artery.
Brief summary
Prospective, multicenter, non-randomized, single-arm registry to evaluate the safety and effectiveness of the iCAST Covered Stent System in the treatment of patients with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery.
Detailed description
STUDY DESIGN: Prospective, multicenter, non-randomized, single-arm registry OBJECTIVE: The primary objective is to evaluate the iCAST covered stent to a performance metric derived from studies of FDA-approved iliac stent devices for treating iliac artery stenoses in patients with de novo or restenotic lesions in the common and/or external iliac arteries. NUMBER OF SUBJECTS: 165 subjects, including up to 25 subjects with totally occluded lesions. PRIMARY ENDPOINTS: The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization or restenosis (by ultrasound determination) within 9 months post-procedure. SECONDARY ENDPOINTS: Secondary endpoints include: 1. Major adverse vascular events (MAVE) defined as a composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, defined as causing end-organ damage (e.g. lower extremity ulceration, tissue necrosis, or gangrene), arterial rupture, acute limb ischemia, target limb amputation or procedure related bleeding event requiring transfusion. 2. A major adverse event (MAE) is defined as a composite rate of MAVE or any death, or stroke, up to 30 days post-procedure. 3. Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system. 4. Acute procedural success, defined as device success and achievement of \< 30% residual stenosis immediately after stent deployment, mean transtenotic pressure gradient of \< 5 mmHg and without occurrence of in-hospital MAVE. 5. Clinical success, assessed both early (30 days) and late (6, 9 and 12 months). 6. Patency assessed at each follow-up time point, categorized as primary, primary-assisted or secondary patency. 7. Composite rate of 30 day death, 9 month target site revascularization and 9 month restenosis in subjects without iliac total occlusions. PATIENT POPULATION: Eligible patients have symptomatic claudication or rest pain and angiographic confirmation of either de novo or restenotic lesions in the common and/or external iliac artery.
Interventions
DEVICEiCAST covered stent
Iliac stent implantation
Sponsors
Atrium Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is 18 years of age or older. 2. Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4). 3. Presence of de novo and/or restenotic lesions in the common and/or external iliac artery. 4. Subject has single, bilateral or multiple target lesions that is (are) ≥ 50% stenosed by visual estimate. 5. The target lesion(s) can be successfully crossed with a guide wire and dilated. 6. The target segment of subject's lesion(s) is between 5 and 12mm in diameter and less than 110 mm in length. 7. Subject has angiographic evidence of a patent profunda or superficial femoral artery (SFA) in the target limb. 8. Subject has provided written informed consent. 9. Subject is able and willing to adhere to the required follow-up visits and testing through month 36. 10. Subject is able and willing to adhere to the required follow-up medication regimen.
Exclusion criteria
1. Presence of other non-target ipsilateral arterial lesions requiring treatment within 30 days post-procedure (Note that treatment of ipsilateral SFA lesions may be allowed under certain circumstances). Treatment of lesions in any other vascular bed must be completed at least 30 days prior to enrollment. 2. The target lesion(s) has adjacent, acute thrombus. 3. The target lesion(s) is highly calcified or was previously treated with a stent. 4. Target lesion involves the internal iliac artery resulting in crossing of the side-branch with the iCAST device (e.g. jailing of the side-branch). 5. Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion. 6. Subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery prior to initiation of the iCAST implant procedure. 7. Subject has a post-surgical stenosis and anastomotic suture treatments of the target vessel. 8. Subject has a vascular graft previously implanted in the native iliac vessel. 9. Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6. 10. Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has a hypersensitivity to stainless steel, expanded polytetrafluoroethylene (ePTFE) or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications. 11. History of neutropenia (WBC \<3,000/mm3), coagulopathy, or thrombocytopenia (platelet count \<80,000/ μL) that has not resolved or has required treatment in the past 6 months. 12. Known bleeding or hypercoagulability disorder or significant anemia (Hb\< 8.0) that cannot be corrected. 13. Subject has the following laboratory values: 1. platelet count less than 80,000/ μL, 2. prothrombin time (PT)/partial thromboplastin time (PTT) not within normal limits 3. serum creatinine level greater than 2.5 mg/dL 14. Subject requires general anesthesia for the procedure. 15. Subject is pregnant. 16. Subject has a co-morbid illness that may result in a life expectancy of less than 1 year. 17. Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. Note: Subjects who are participating in the long term follow-up phase of a previously investigational and now FDA-approved product are not excluded by this criterion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis | Within 9 Months post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Procedural Success | Post-procedure | Device success and achievement of \< 30% residual stenosis immediately after stent placement and without occurrence of in-hospital MAVE. |
| Device Success | Post-procedure | Successful delivery and deployment of the study stent and intact retrieval of the delivery system. |
| Major Adverse Event (MAE) | 30 Days | Composite rate of MAVE or any death, or stroke. |
| Major Adverse Vascular Event (MAVE) | 30 Days | 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. |
| Primary Patency | 1 Month | Continuous flow without revascularization, bypass or target limb amputation. |
| Late Clinical Success | 6 Months | Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. |
| Primary-Assisted Patency | 1 Month | Continuous flow assisted when the target vessel has restenosed at any time post-procedure. |
| Secondary Patency | 1 Month | Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel. |
| Early Clinical Success | 1 Month | 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.) |
Countries
Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device: ICAST Covered Stent Implantation of ≥ 1 ICAST stent | 152 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 14 |
| Overall Study | Lost to Follow-up | 17 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Device: ICAST Covered Stent |
|---|---|
| Age, Continuous | 65.23 years STANDARD_DEVIATION 9.96 |
| Cerebrovascular Accident | 11 Participants |
| Cigarette Smoking Status Current smoker | 76 Participants |
| Cigarette Smoking Status Former smoker | 62 Participants |
| Cigarette Smoking Status Non-smoker | 13 Participants |
| Cigarette Smoking Status Unknown | 0 Participants |
| Coronary Artery Bypass Graft Surgery | 34 Participants |
| Coronary Artery Disease | 77 Participants |
| Diabetes Mellitus | 56 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 149 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hypercholesterolemia | 130 Participants |
| Hypertension | 129 Participants |
| Previous Amputation | 2 Participants |
| Previous Myocardial Infarction (MI) | 35 Participants |
| Previous percutaneous coronary revascularization | 39 Participants |
| Previous Peripheral Artery Revascularization/Surgery | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 142 Participants |
| Region of Enrollment Germany | 20 participants |
| Region of Enrollment United States | 132 participants |
| Renal Insufficiency | 19 Participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 94 Participants |
| Transient Ischemic Attack | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 14 / 165 |
| other Total, other adverse events | 22 / 165 |
| serious Total, serious adverse events | 86 / 165 |
Outcome results
Primary
Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis
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
Population: ITT population: Subjects who signed the written informed consent, enrolled in the study and met the study entry criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| iCAST Covered Stent | Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis | 8.1 Percentage of subjects |
Comparison: 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%.p-value: 0.005Exact test of the binomial distribution
Secondary
Acute Procedural Success
Device success and achievement of \< 30% residual stenosis immediately after stent placement and without occurrence of in-hospital MAVE.
Time frame: Post-procedure
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Acute Procedural Success | 140 Participants |
Secondary
Device Success
Successful delivery and deployment of the study stent and intact retrieval of the delivery system.
Time frame: Post-procedure
Population: ITT population: Subjects who signed the written informed consent, enrolled in the study and met the study entry criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Device Success | 150 Participants |
Secondary
Early Clinical Success
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Early Clinical Success | 133 Participants |
Secondary
Late Clinical Success
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Late Clinical Success | 80 Participants |
Secondary
Late Clinical Success
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Late Clinical Success | 86 Participants |
Secondary
Late Clinical Success
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Late Clinical Success | 80 Participants |
Secondary
Late Clinical Success
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Late Clinical Success | 76 Participants |
Secondary
Late Clinical Success
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Late Clinical Success | 98 Participants |
Secondary
Major Adverse Event (MAE)
Composite rate of MAVE or any death, or stroke.
Time frame: 30 Days
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Major Adverse Event (MAE) | 8 Participants |
Secondary
Major Adverse Vascular Event (MAVE)
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Major Adverse Vascular Event (MAVE) | 10 Participants |
Secondary
Major Adverse Vascular Event (MAVE)
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Major Adverse Vascular Event (MAVE) | 10 Participants |
Secondary
Major Adverse Vascular Event (MAVE)
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Major Adverse Vascular Event (MAVE) | 10 Participants |
Secondary
Major Adverse Vascular Event (MAVE)
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Major Adverse Vascular Event (MAVE) | 7 Participants |
Secondary
Primary-Assisted Patency
Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Time frame: 24 Months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Primary-Assisted Patency | 128 Participants |
Secondary
Primary-Assisted Patency
Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Time frame: 12 Months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Primary-Assisted Patency | 138 Participants |
Secondary
Primary-Assisted Patency
Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Time frame: 9 Months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Primary-Assisted Patency | 139 Participants |
Secondary
Primary-Assisted Patency
Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Time frame: 6 Months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Primary-Assisted Patency | 144 Participants |
Secondary
Primary-Assisted Patency
Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Time frame: 1 Month
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Primary-Assisted Patency | 151 Participants |
Secondary
Primary-Assisted Patency
Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
Time frame: 36 Months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Primary-Assisted Patency | 114 Participants |
Secondary
Primary Patency
Continuous flow without revascularization, bypass or target limb amputation.
Time frame: 9 Months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Primary Patency | 134 Participants |
Secondary
Primary Patency
Continuous flow without revascularization, bypass or target limb amputation.
Time frame: 1 Month
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Primary Patency | 151 Participants |
Secondary
Primary Patency
Continuous flow without revascularization, bypass or target limb amputation.
Time frame: 6 Months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Primary Patency | 143 Participants |
Secondary
Primary Patency
Continuous flow without revascularization, bypass or target limb amputation.
Time frame: 12 Months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Primary Patency | 129 Participants |
Secondary
Primary Patency
Continuous flow without revascularization, bypass or target limb amputation.
Time frame: 24 Months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Primary Patency | 113 Participants |
Secondary
Primary Patency
Continuous flow without revascularization, bypass or target limb amputation.
Time frame: 36 Months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Primary Patency | 100 Participants |
Secondary
Secondary Patency
Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Time frame: 1 Month
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Secondary Patency | 151 Participants |
Secondary
Secondary Patency
Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Time frame: 6 Months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Secondary Patency | 144 Participants |
Secondary
Secondary Patency
Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Time frame: 9 Months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Secondary Patency | 139 Participants |
Secondary
Secondary Patency
Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Time frame: 12 Months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Secondary Patency | 138 Participants |
Secondary
Secondary Patency
Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Time frame: 24 Months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Secondary Patency | 129 Participants |
Secondary
Secondary Patency
Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Time frame: 36 Months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCAST Covered Stent | Secondary Patency | 115 Participants |