Atrium iCAST Iliac Stent Pivotal Study

Peripheral Vascular Disease Clinical Trial

— iCARUS  

Official title:

Atrium iCAST Iliac Stent Pivotal Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00593385
• Other study ID #: Atrium 701
• Status: Completed
• Phase: N/A
• Start date: October 2007
• Est. completion date: May 2014

Study information

• Verified date: April 2018
• Source: Atrium Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: May 2014
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• iCAST covered stent
Iliac stent implantation

Locations

Country	Name	City	State
Germany	Herzzentrum Bad Krozingen	Bad Krozingen
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Piedmont Hospital Research Institute	Atlanta	Georgia
United States	Mass General Hospital	Boston	Massachusetts
United States	Holy Spirit Cardiovascular Institute	Camp Hill	Pennsylvania
United States	Northwestern University	Chicago	Illinois
United States	Lindner Clinical Trial Center	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals, Case Medical Center	Cleveland	Ohio
United States	MidWest Cardiology Research Foundation	Columbus	Ohio
United States	Cardiovascular Research Institute of Dallas	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Forest General Hospital	Hattiesburg	Mississippi
United States	Terrebonne General Medical Center	Houma	Louisiana
United States	The Methodist Hospital	Houston	Texas
United States	Krannert Institute of Cardiology	Indianapolis	Indiana
United States	Kansas City Heart Foundation	Kansas City	Missouri
United States	Tennova Healthcare - Turkey Creek Medical Center	Knoxville	Tennessee
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	University of Louisville	Louisville	Kentucky
United States	Fogarty Clincal Research Incorporated	Mountain View	California
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	University of California, Davis	Sacramento	California
United States	North Central Heart Institute	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Atrium Medical Corporation

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Within 9 Months post-procedure
Secondary	Acute Procedural Success	Device success and achievement of < 30% residual stenosis immediately after stent placement and without occurrence of in-hospital MAVE.	Post-procedure
Secondary	Device Success	Successful delivery and deployment of the study stent and intact retrieval of the delivery system.	Post-procedure
Secondary	Major Adverse Event (MAE)	Composite rate of MAVE or any death, or stroke.	30 Days
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.	30 Days
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.	180 Days
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.	270 Days
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.	360 Days
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.)	1 Month
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.	6 Months
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.	9 Months
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.	12 Months
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.	24 Months
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.	36 Months
Secondary	Primary Patency	Continuous flow without revascularization, bypass or target limb amputation.	1 Month
Secondary	Primary Patency	Continuous flow without revascularization, bypass or target limb amputation.	6 Months
Secondary	Primary Patency	Continuous flow without revascularization, bypass or target limb amputation.	9 Months
Secondary	Primary Patency	Continuous flow without revascularization, bypass or target limb amputation.	12 Months
Secondary	Primary Patency	Continuous flow without revascularization, bypass or target limb amputation.	24 Months
Secondary	Primary Patency	Continuous flow without revascularization, bypass or target limb amputation.	36 Months
Secondary	Primary-Assisted Patency	Continuous flow assisted when the target vessel has restenosed at any time post-procedure.	1 Month
Secondary	Primary-Assisted Patency	Continuous flow assisted when the target vessel has restenosed at any time post-procedure.	6 Months
Secondary	Primary-Assisted Patency	Continuous flow assisted when the target vessel has restenosed at any time post-procedure.	9 Months
Secondary	Primary-Assisted Patency	Continuous flow assisted when the target vessel has restenosed at any time post-procedure.	12 Months
Secondary	Primary-Assisted Patency	Continuous flow assisted when the target vessel has restenosed at any time post-procedure.	24 Months
Secondary	Primary-Assisted Patency	Continuous flow assisted when the target vessel has restenosed at any time post-procedure.	36 Months
Secondary	Secondary Patency	Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.	1 Month
Secondary	Secondary Patency	Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.	6 Months
Secondary	Secondary Patency	Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.	9 Months
Secondary	Secondary Patency	Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.	12 Months
Secondary	Secondary Patency	Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.	24 Months
Secondary	Secondary Patency	Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.	36 Months