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

Not Applicable

Completed

Conditions: Peripheral Artery Disease

Interventions: Device: Scuba Iliac Stent System

Registration Number: NCT00880230

Lead Sponsor: Medtronic Endovascular

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 141

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Scuba Iliac Stent System	Scuba Iliac Stent System	Device: Scuba™ iliac stent

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
Patency - Secondary	9 Months	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.
Device Success	At time of deployment	The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system.
Patency - Primary	9 Months	Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 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	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.
Procedural Success	Up to the moment the catheter sheath introducer has been removed	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).
Patency - Primary Assisted	9 Months	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.
Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination)	9 Months	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.
Death	9 Months	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.
Clinical Success	9 Months	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.
Target Limb Revascularization	9 Months	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.
Target Limb Loss	9 Months	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.

Trial Locations

Locations (3): Hamburg University Cardiovascular Center
🇩🇪
Hamburg, Germany
Greenville Hospital System
🇺🇸
Greenville, South Carolina, United States
Baptist Hospital of Miami
🇺🇸
Miami, Florida, United States