At a glance
ClinicalIndex Comparison RecordN/ACompleted· 141 enrolled
Drug / intervention
Scuba Iliac Stent Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
INTENSE: Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent
In Brief
A clinical study evaluating Scuba Iliac Stent System for Peripheral Artery Disease. Completed, enrolled 141 participants across 3 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Artery Disease
CountriesGermany, United States
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedApr 2009
Primary CompletionJun 2011
Study CompletionDec 2012
TodayJul 2026
First PostedApr 13, 2009
Enrollment StartMar 1, 2009
Primary CompletionJun 1, 2011
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.2 years ago
Interventions
Scuba Iliac Stent Systemdevice
The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.