NCT00844532

Trial to Evaluate the Safety & 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.

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	Absolute Pro™ Peripheral Self-Expanding Stent System	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).

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-03-01
• Completion: 2014-06-01
• First posted: 2009-02-16
• Last updated: 2015-06-09
• Results posted: 2012-09-07

Locations

1 site across 1 country: United States