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Atrium iCAST Iliac Stent Pivotal Study (iCARUS)

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ClinicalTrials.gov Identifier: NCT00593385
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Atrium Medical Corporation

Tracking Information
First Submitted Date  ICMJE January 2, 2008
First Posted Date  ICMJE January 15, 2008
Results First Submitted Date  ICMJE February 12, 2018
Results First Posted Date  ICMJE May 17, 2018
Last Update Posted Date May 17, 2018
Study Start Date  ICMJE October 2007
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
  • Acute Procedural Success [ Time Frame: Post-procedure ]
    Device success and achievement of < 30% residual stenosis immediately after stent placement and without occurrence of in-hospital MAVE.
  • Device Success [ Time Frame: Post-procedure ]
    Successful delivery and deployment of the study stent and intact retrieval of the delivery system.
  • Major Adverse Event (MAE) [ Time Frame: 30 Days ]
    Composite rate of MAVE or any death, or stroke.
  • Major Adverse Vascular Event (MAVE) [ Time Frame: 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.
  • Major Adverse Vascular Event (MAVE) [ Time Frame: 180 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.
  • Major Adverse Vascular Event (MAVE) [ Time Frame: 270 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.
  • Major Adverse Vascular Event (MAVE) [ Time Frame: 360 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.
  • Early Clinical Success [ Time Frame: 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.)
  • Late Clinical Success [ Time Frame: 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.
  • Late Clinical Success [ Time Frame: 9 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.
  • Late Clinical Success [ Time Frame: 12 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.
  • Late Clinical Success [ Time Frame: 24 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.
  • Late Clinical Success [ Time Frame: 36 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 Patency [ Time Frame: 1 Month ]
    Continuous flow without revascularization, bypass or target limb amputation.
  • Primary Patency [ Time Frame: 6 Months ]
    Continuous flow without revascularization, bypass or target limb amputation.
  • Primary Patency [ Time Frame: 9 Months ]
    Continuous flow without revascularization, bypass or target limb amputation.
  • Primary Patency [ Time Frame: 12 Months ]
    Continuous flow without revascularization, bypass or target limb amputation.
  • Primary Patency [ Time Frame: 24 Months ]
    Continuous flow without revascularization, bypass or target limb amputation.
  • Primary Patency [ Time Frame: 36 Months ]
    Continuous flow without revascularization, bypass or target limb amputation.
  • Primary-Assisted Patency [ Time Frame: 1 Month ]
    Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
  • Primary-Assisted Patency [ Time Frame: 6 Months ]
    Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
  • Primary-Assisted Patency [ Time Frame: 9 Months ]
    Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
  • Primary-Assisted Patency [ Time Frame: 12 Months ]
    Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
  • Primary-Assisted Patency [ Time Frame: 24 Months ]
    Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
  • Primary-Assisted Patency [ Time Frame: 36 Months ]
    Continuous flow assisted when the target vessel has restenosed at any time post-procedure.
  • Secondary Patency [ Time Frame: 1 Month ]
    Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
  • Secondary Patency [ Time Frame: 6 Months ]
    Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
  • Secondary Patency [ Time Frame: 9 Months ]
    Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
  • Secondary Patency [ Time Frame: 12 Months ]
    Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
  • Secondary Patency [ Time Frame: 24 Months ]
    Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
  • Secondary Patency [ Time Frame: 36 Months ]
    Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Atrium iCAST Iliac Stent Pivotal Study
Official Title  ICMJE Atrium iCAST Iliac Stent Pivotal Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Vascular Disease
Intervention  ICMJE Device: iCAST covered stent
Iliac stent implantation
Study Arms  ICMJE iCAST covered stent
This is a one arm trial. All subjects received the iCAST covered stent.
Intervention: Device: iCAST covered stent
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2010)
165
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00593385
Other Study ID Numbers  ICMJE Atrium 701
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Atrium Medical Corporation
Study Sponsor  ICMJE Atrium Medical Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John R Laird, MD Adventist Health
PRS Account Atrium Medical Corporation
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP