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

NCT ID: NCT00880230

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-12-31

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.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Scuba Iliac Stent System

Device: Scuba™ iliac stent

Group Type: EXPERIMENTAL

Scuba Iliac Stent System

Intervention Type: DEVICE

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

Interventions

Scuba Iliac Stent System

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

Intervention Type: DEVICE

Other Intervention Names

Scuba

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Endovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce H Gray, DO

Role: PRINCIPAL_INVESTIGATOR

Greeville Health System

Barry T Katzen, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Health South Florida

Locations

Baptist Hospital of Miami

Miami, Florida, United States

Greenville Hospital System

Greenville, South Carolina, United States

Hamburg University Cardiovascular Center

Hamburg, , Germany

Countries

United States; Germany

Other Identifiers

P-999

Identifier Type: -

Identifier Source: org_study_id