INTENSE: Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 6
- 主要终点
- Composite of Major Adverse Events (MAE) Defined as the Occurrence of In-hospital Myocardial Infarction (MI) or Target Segment Revascularization, Target Limb Loss, or Death Within 9 Months Post-procedure.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Composite of Major Adverse Events (MAE) Defined as the Occurrence of In-hospital Myocardial Infarction (MI) or Target Segment Revascularization, Target Limb Loss, or Death Within 9 Months Post-procedure.
时间窗: In-hospital and 9 Months
The analysis is based on the percentage of Intent to Treat subjects (ITT) who experienced the primary endpoint or who had adequate follow-up for the 9-month analysis. A subject had adequate follow-up if he/she had an event or had a follow-up of at least 256 days, allowing for a visit window of 9 months +/- 14 days.
次要结局
- Patency - Secondary(9 Months)
- Device Success(At time of deployment)
- Patency - Primary(9 Months)
- Major Adverse Vascular Events Through 30 Days as a Composite of (MI, Death or Stroke, Stent Thrombosis, Distal Embolization, Arterial Rupture/Perforation, Acute Limb Ischemia, Target Limb Loss, Procedure-related Bleeding Event Requiring Transfusion)(30 Days)
- Procedural Success(Up to the moment the catheter sheath introducer has been removed)
- Patency - Primary Assisted(9 Months)
- Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination)(9 Months)
- Death(9 Months)
- Clinical Success(9 Months)
- Target Limb Revascularization(9 Months)
- Target Limb Loss(9 Months)