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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: Scuba Iliac Stent System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scuba Iliac Stent System<br>Device: Scuba™ iliac stent | Device: Scuba Iliac Stent System<br>* The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.<br>* Other names: Scuba;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | In-hospital and 9 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | The analysis is based on the number of patients who experienced either an MI, died, had a stroke, stent thrombosis, distal embolization, arterial rupture/perforation limb ischemia, lost a target limb, or had a bleeding event due to the procedure within 30 days after being treated with the Scuba iliac stent. | 30 Days | 
| Device Success | The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system. | At time of deployment | 
| Procedural Success | The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system [Device Success] and the achievement of <30% residual stenosis immediately after stent deployment, without occurrence of in-hospital Major Adverse Events (MAE). | Up to the moment the catheter sheath introducer has been removed | 
| Clinical Success | Early Clinical Success (30 days) is defined as improvement of the Rutherford-Becker scale criteria by greater than or equal to one category as obtained at the 30 day follow-up visit. | 30 Days | 
| Clinical Success | Late Clinical Success (6 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success. | 6 Months | 
| Clinical Success | Late Clinical Success (9 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success. | 9 Months | 
| Patency - Primary | Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months. | 6 Months | 
| Patency - Primary Assisted | Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 6 months. | 6 Months | 
| Patency - Secondary | Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 6 months. | 6 Months | 
| Patency - Primary | Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 9 months. | 9 Months | 
| Patency - Primary Assisted | Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 9 months. | 9 Months | 
| Patency - Secondary | Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 9 months. | 9 Months | 
| Target Limb Revascularization | Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery. | 9 Months | 
| Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination) | Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery. | 9 Months | 
| Death | Death can be classified as one of three categories: cardiac, vascular, or non-cardiovascular. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. | 9 Months | 
| Target Limb Loss | Amputation of the target limb by surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target segment. Amputations are subclassified as: Above the knee, Below the knee, Transmetatarsal, and Toe. | 9 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iliac Artery Stenting, Peripheral Artery Disease