Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)

INTENSE: Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent

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.

Interventional revascularization strategies for peripheral arterial disease currently available include both surgical and endovascular approaches such as percutaneous transluminal angioplasty (PTA), either as a stand-alone procedure or with the placement of a stent. Cobalt-chromium (CoCr) is an alloy that has been used safely in the manufacture of surgical implants for use in contact with blood, soft tissue and bone for over 10 years. This study will evaluate the SCUBA™ peripheral balloon-expandable cobalt chromium tent system in iliac arteries.

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 Common Femoral Artery (CFA), Profundal Femoral Artery (PFA), or Superficial Femoral Artery (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)
• International Normalized ratio (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