Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE) - Full Text View

Purpose

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.

Condition	Intervention
Peripheral Artery Disease	Device: Scuba™ Stent System

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	INTENSE: Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent

Resource links provided by NLM:

MedlinePlus related topics: Limb Loss Peripheral Arterial Disease

U.S. FDA Resources

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:

Composite of major adverse events (MAE) defined as the occurrence of in-hospital myocardial infarction (MI) target segment revascularization, target limb loss, or death within 9 months post-procedure. [ Time Frame: In-hospital and 9 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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) [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
Device Success [ Time Frame: Post-procedure ] [ Designated as safety issue: Yes ]
Procedural Success [ Time Frame: Hospital Discharge ] [ Designated as safety issue: Yes ]
Clinical Success [ Time Frame: 30 Days, 6 Months, 9 Months ] [ Designated as safety issue: No ]
Patency - Primary, Primary-assisted, and Secondary [ Time Frame: 6 Months and 9 Months ] [ Designated as safety issue: Yes ]
Quality of Life Assessment [ Time Frame: Baseline, 3 Months and 9 Months ] [ Designated as safety issue: No ]
Functional Testing [ Time Frame: Baseline, 3, 9, 12, 24, and 36 Months ] [ Designated as safety issue: No ]
Target Lesion Revascularization [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
Death [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
Target Limb Loss [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
Restenosis Rate (≥ 50% diameter stenosis by duplex ultrasound determination) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	140
Study Start Date:	March 2009
Estimated Study Completion Date:	August 2013
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Device: Scuba™ Stent System Iliac Stenting	Device: Scuba™ Stent System The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system. Other Name: Scuba

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 CFA, PFA, or 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)
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880230

Locations

United States, Florida
Baptist Hospital of Miami
Miami, Florida, United States, 33176
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605
Germany
Hamburg University Cardiovascular Center
Hamburg, Germany, 22527

Sponsors and Collaborators

Medtronic Endovascular

Investigators

Principal Investigator:	Bruce H Gray, DO	Greeville Health System
Principal Investigator:	Barry T Katzen, MD	Baptist Health South Florida

More Information

No publications provided

Responsible Party:	Medtronic Endovascular
ClinicalTrials.gov Identifier:	NCT00880230 History of Changes
Other Study ID Numbers:	P-999
Study First Received:	April 10, 2009
Last Updated:	August 3, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:

Iliac Artery Stenting
Peripheral Artery Disease

Additional relevant MeSH terms:

Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

Chromium
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013