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: June 23, 2014
Last verified: June 2014
  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:


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: August 2014
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 (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593385

  Hide Study Locations
Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Fogarty Clincal Research Incorporated
Mountain View, California, United States, 94040
University of California, Davis
Sacramento, California, United States, 95817
United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Piedmont Hospital Research Institute
Atlanta, Georgia, United States, 30309
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Krannert Institute of Cardiology
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Terrebonne General Medical Center
Houma, Louisiana, United States, 70360
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Mass General Hospital
Boston, Massachusetts, United States, 02114
United States, Mississippi
Forest General Hospital
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Kansas City Heart Foundation
Kansas City, Missouri, United States, 64132
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219
University Hospitals, Case Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
MidWest Cardiology Research Foundation
Columbus, Ohio, United States, 43214
United States, Pennsylvania
Holy Spirit Cardiovascular Institute
Camp Hill, Pennsylvania, United States, 17011
United States, South Dakota
North Central Heart Institute
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, United States, 37934
United States, Texas
Cardiovascular Research Institute of Dallas
Dallas, Texas, United States, 75231
The Methodist Hospital
Houston, Texas, United States, 77030
Germany
Herzzentrum Bad Krozingen
Bad Krozingen, Germany
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: June 23, 2014
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 July 26, 2014