NCT00880230

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-06-01
• Completion: 2012-12-01
• First posted: 2009-04-13
• Last updated: 2016-02-26
• Results posted: 2013-06-10

Locations

3 sites across 2 countries: United States, Germany