Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)
Completed · Not applicable
Conditions studied: Peripheral Artery Disease
In brief
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.
Key facts
- Study ID
- NCT00880230
- Run by
- Medtronic Endovascular
- People needed
- 141
- Starts
- 2009-03-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2016-02-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Baptist Hospital of Miami — Miami, Florida, United States
- Greenville Hospital System — Greenville, South Carolina, United States
- Hamburg University Cardiovascular Center — Hamburg, Germany
Full record on ClinicalTrials.gov
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