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

Medtronic Endovascular141 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

141

Conditions

Peripheral Artery Disease

Interventions

Scuba Iliac Stent SystemDEVICE

The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Baptist Hospital of Miami

Miami, Florida, United States

Greenville Hospital System

Greenville, South Carolina, United States

Hamburg University Cardiovascular Center

Hamburg, Germany

Outcomes

Primary Outcomes

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.

Time frame: In-hospital and 9 Months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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