NCT01396525

Trial to Evaluate the Safety & 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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 153 (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 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.

Detailed description

The MOBILITY study was a prospective, non-randomized, two-arm, multi-center study. The 2 arms (Omnilink Elite arm and Absolute Pro arm) were designed to independently assess the safety and effectiveness of the 2 devices used in this study.

Conditions

• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	Omnilink Elite™ Peripheral Balloon-Expandable Stent System	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).

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-09-01
• Completion: 2014-06-01
• First posted: 2011-07-18
• Last updated: 2016-02-08
• Results posted: 2012-10-01

Locations

1 site across 1 country: United States