Clinical trial NCT00593385: Atrium iCAST Iliac Stent Pivotal Study
Official title: Atrium iCAST Iliac Stent Pivotal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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.
Lead sponsor: Atrium Medical Corporation
Sponsor class: INDUSTRY
First posted: 2008-01-15
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis
timeFrame: Within 9 Months post-procedure
Secondary outcomes:
measure: Acute Procedural Success
timeFrame: Post-procedure
measure: Device Success
timeFrame: Post-procedure
measure: Major Adverse Event (MAE)
timeFrame: 30 Days
measure: Major Adverse Vascular Event (MAVE)
timeFrame: 30 Days
measure: Major Adverse Vascular Event (MAVE)
timeFrame: 180 Days
measure: Major Adverse Vascular Event (MAVE)
timeFrame: 270 Days
measure: Major Adverse Vascular Event (MAVE)
timeFrame: 360 Days
measure: Early Clinical Success
timeFrame: 1 Month
measure: Late Clinical Success
timeFrame: 6 Months
measure: Late Clinical Success
timeFrame: 9 Months
measure: Late Clinical Success
timeFrame: 12 Months
measure: Late Clinical Success
timeFrame: 24 Months
measure: Late Clinical Success
timeFrame: 36 Months
measure: Primary Patency
timeFrame: 1 Month
measure: Primary Patency
timeFrame: 6 Months
measure: Primary Patency
timeFrame: 9 Months
measure: Primary Patency
timeFrame: 12 Months
measure: Primary Patency
timeFrame: 24 Months
measure: Primary Patency
timeFrame: 36 Months
measure: Primary-Assisted Patency
timeFrame: 1 Month
measure: Primary-Assisted Patency
timeFrame: 6 Months
measure: Primary-Assisted Patency
timeFrame: 9 Months
measure: Primary-Assisted Patency
timeFrame: 12 Months
measure: Primary-Assisted Patency
timeFrame: 24 Months
measure: Primary-Assisted Patency
timeFrame: 36 Months
measure: Secondary Patency
timeFrame: 1 Month
measure: Secondary Patency
timeFrame: 6 Months
measure: Secondary Patency
timeFrame: 9 Months
measure: Secondary Patency
timeFrame: 12 Months
measure: Secondary Patency
timeFrame: 24 Months
measure: Secondary Patency
timeFrame: 36 Months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Mountain View
country: United States
facility: Fogarty Clincal Research Incorporated
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hospital Research Institute
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Krannert Institute of Cardiology
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Houma
country: United States
facility: Terrebonne General Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Mass General Hospital
state: Massachusetts
city: Hattiesburg
country: United States
facility: Forest General Hospital
state: Mississippi
city: Kansas City
country: United States
facility: Kansas City Heart Foundation
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Lindner Clinical Trial Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals, Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: MidWest Cardiology Research Foundation
state: Ohio
city: Camp Hill
country: United States
facility: Holy Spirit Cardiovascular Institute
state: Pennsylvania
city: Sioux Falls
country: United States
facility: North Central Heart Institute
state: South Dakota
city: Knoxville
country: United States
facility: Tennova Healthcare - Turkey Creek Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Cardiovascular Research Institute of Dallas
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
Study officials:
affiliation: Adventist Health
name: John R Laird, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.