Atrium iCAST Iliac Stent Pivotal Study

NCT00593385 | Completed Results DMC

• 1 other identifier: Atrium 701
• Study Type: interventional
• Target: 165
• Locations: 2 countries
• Sites: 25

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.

Conditions

Peripheral Vascular Disease

Keywords

Symptomatic claudication or rest pain and angiographic confirmation of either de novo or restenotic lesions in the common and/or external iliac artery.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (31)

• Acute Procedural Success

  Post-procedure

• Device Success

  Post-procedure

• Major Adverse Event (MAE)

  30 Days

• Major Adverse Vascular Event (MAVE)

  30 Days

• Major Adverse Vascular Event (MAVE)

  180 Days

Study Arms (1)

iCAST covered stent

OTHER

This is a one arm trial. All subjects received the iCAST covered stent.

Device: iCAST covered stent

Interventions

iCAST covered stent DEVICE

Iliac stent implantation

iCAST covered stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18 years of age or older.
• Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4).
• Presence of de novo and/or restenotic lesions in the common and/or external iliac artery.
• Subject has single, bilateral or multiple target lesions that is (are) ≥ 50% stenosed by visual estimate.
• The target lesion(s) can be successfully crossed with a guide wire and dilated.
• The target segment of subject's lesion(s) is between 5 and 12mm in diameter and less than 110 mm in length.
• Subject has angiographic evidence of a patent profunda or superficial femoral artery (SFA) in the target limb.
• Subject has provided written informed consent.
• Subject is able and willing to adhere to the required follow-up visits and testing through month 36.
• Subject is able and willing to adhere to the required follow-up medication regimen.

You may not qualify if:

• 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.
• The target lesion(s) has adjacent, acute thrombus.
• The target lesion(s) is highly calcified or was previously treated with a stent.
• 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).
• Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion.
• 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.
• Subject has a post-surgical stenosis and anastomotic suture treatments of the target vessel.
• Subject has a vascular graft previously implanted in the native iliac vessel.
• Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
• 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.
• 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.
• Known bleeding or hypercoagulability disorder or significant anemia (Hb\< 8.0) that cannot be corrected.
• Subject has the following laboratory values:
• platelet count less than 80,000/ μL,
• prothrombin time (PT)/partial thromboplastin time (PTT) not within normal limits

Sponsors & Collaborators

• Atrium Medical Corporation: lead

Study Sites (25)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Fogarty Clincal Research Incorporated

Mountain View, California, 94040, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Piedmont Hospital Research Institute

Atlanta, Georgia, 30309, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Krannert Institute of Cardiology

Indianapolis, Indiana, 46202, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Terrebonne General Medical Center

Houma, Louisiana, 70360, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

Forest General Hospital

Hattiesburg, Mississippi, 39401, United States

Location

Kansas City Heart Foundation

Kansas City, Missouri, 64132, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

University Hospitals, Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MidWest Cardiology Research Foundation

Columbus, Ohio, 43214, United States

Location

Holy Spirit Cardiovascular Institute

Camp Hill, Pennsylvania, 17011, United States

Location

North Central Heart Institute

Sioux Falls, South Dakota, 57108, United States

Location

Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

Cardiovascular Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Location

Related Publications (1)

• Laird JR, Loja M, Zeller T, Niazi KAK, Foster MT, Ansel G, Stone DH, Dave RM, Popma JJ, Jaff MR, Massaro JM. iCAST Balloon-Expandable Covered Stent for Iliac Artery Lesions: 3-Year Results from the iCARUS Multicenter Study. J Vasc Interv Radiol. 2019 Jun;30(6):822-829.e4. doi: 10.1016/j.jvir.2018.12.707. Epub 2019 Apr 25.

  PMID: 31031089 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Elizabeth Bulger, Director of Clinical Affairs
• Organization: Getinge

elizabeth.bulger@getinge.com

1-603-864-5368

Study Officials

• John R Laird, MD

  Adventist Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 15, 2008
• Study Start: October 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: May 1, 2014
• Last Updated: May 17, 2018
• Results First Posted: May 17, 2018

Record last verified: 2018-04

Locations

US (24); DE (1)