At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Non-randomized, 2 Arm (AP Arm & Omni-Link Elite [OE] Arm-separately Posted as: NCT01396525), 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. CAUTION: The Omnilink Elite™ Peripheral Balloon-expandable Stent System is an Investigational Device. Limited by Federal (U.S.) Law to Investigational Use Only.
In Brief
A Phase 3 clinical trial evaluating Absolute Pro™ Peripheral Self-Expanding Stent System for Peripheral Vascular Disease. Completed, enrolled 151 participants across 1 site.
Detailed Summary
To determine the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding 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
Timeline
Interventions
Absolute Pro™ Peripheral Self-Expanding Stent System: Devices include both Absolute Pro™ and Absolute Pro™ LL Peripheral Self-Expanding Stent Systems. It is indicated for the 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).