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Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE) - NCT00880230-29615(Clinical Trial 283978)



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City:  Greenville
State:  
SC
Zip Code: 29615
Conditions: Peripheral Artery Disease
Purpose: The purpose of this study is to determine the safety and effectiveness of the Scuba™ stent in subjects with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery.
Study summary:
Criteria: Inclusion Criteria: - Presence of de novo or restenotic lesion(s), located in the common or external iliac artery with ≥50% stenosis - Subject has lifestyle limiting claudication or rest pain, (Rutherford- Becker scale [clinical category] 2, 3, or 4) - Target vessel reference diameter is 5mm - 10mm by visual assessment - Target lesion length < 130mm - Subject has angiographic evidence of a patent femoral outflow artery in the target limb - Subject has provided written informed consent - Subject is able and willing to adhere to required follow-up visits and testing Exclusion Criteria: - Subject has lesions in the CFA, PFA, or SFA that would require a staged procedure within 30 days of the index procedure (either before or after) - Target lesion(s) has adjacent, acute thrombus - Target lesion(s) is highly calcified or was previously treated with a stent - Subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery - Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion - Subject has a post-surgical stenosis and anastomotic suture treatments in the native iliac vessel - Subject has a vascular graft previously implanted in the native iliac vessel - Subject has tissue loss - Rutherford-Becker clinical category 5 or 6 - History of neutropenia (WBC <3,000/mm3), coagulopathy, or thrombocytopenia (platelet count <80,000/uL) - INR greater than 1.5 - Serum creatinine greater than 2.5 mg/dL - Subject has a known bleeding or hypercoagulability disorder or significant anemia (Hb < 8.0 g/dL) that cannot be corrected - Subject is participating in an investigational study of a new drug, biologic, or device at the same time of study screening
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Data Source: ClinicalTrials.gov
Date Processed: August 3, 2010
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