At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 153 enrolled
Drug / intervention
Omnilink Elite™ Peripheral Balloon-Expandable 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.
A Prospective, Non-randomized, Two Arm, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System and the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery.
In Brief
A Phase 3 clinical trial evaluating Omnilink Elite™ Peripheral Balloon-Expandable Stent System for Peripheral Vascular Disease. Completed, enrolled 153 participants across 1 site.
Detailed Summary
To determine the safety and efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Vascular Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedJul 2011
Primary CompletionSep 2011
Study CompletionJun 2014
TodayJul 2026
First PostedJul 18, 2011
Enrollment StartMar 1, 2009
Primary CompletionSep 1, 2011
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.0 years ago
Interventions
Omnilink Elite™ Peripheral Balloon-Expandable Stent Systemdevice
Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).