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Atrium iCAST Iliac Stent Pivotal Study (iCARUS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Atrium Medical Corporation
ClinicalTrials.gov Identifier:
NCT00593385
First received: January 2, 2008
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose

STUDY DESIGN: Prospective, multicenter, non-randomized, one 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.


Condition Intervention
Peripheral Vascular Disease
 Device: iCAST covered stent

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Atrium iCAST Iliac Stent Pivotal Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Atrium Medical Corporation:

Primary Outcome Measures:
  • The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization or restenosis (by ultrasound determination) [ Time Frame: 30 days and within 9 months post-procedure. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MAVE [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • A major adverse event (MAE) is defined as a composite rate of MAVE or any death, or stroke. [ Time Frame: Up to 30 days post-procedure. ] [ Designated as safety issue: No ]
  • Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system. [ Time Frame: Acute ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Acute ] [ Designated as safety issue: No ]
  • Clinical success [ Time Frame: 30 days, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Patency assessed at each follow-up time point, categorized as primary, primary-assisted or secondary patency. [ Time Frame: Discharge, 1, 6 and 9 months, 1, 2, and 3 years ] [ Designated as safety issue: No ]
  • Composite rate of 30 day death, 9 month target site revascularization and 9 month restenosis in subjects without iliac total occlusions. [ Time Frame: 30 days and 9 months ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: October 2007
Estimated Study Completion Date: October 2013
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
iCAST covered stent
This is a one arm trial. All subjects received the iCAST covered stent.
 Device: iCAST covered stent
iliac stent implantation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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, 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. PT/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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593385

  Show 25 Study Locations
Sponsors and Collaborators
Atrium Medical Corporation
Investigators
Principal Investigator: John R Laird, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Atrium Medical Corporation
ClinicalTrials.gov Identifier: NCT00593385     History of Changes
Other Study ID Numbers: Atrium 701
Study First Received: January 2, 2008
Last Updated: August 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Atrium Medical Corporation:
Symptomatic claudication or rest pain and angiographic confirmation of either de novo or restenotic lesions in the common and/or external iliac artery.

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
 Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 21, 2013