NCT00730730

The Complete® Self-Expanding Stent and Stent Delivery System Registry

The Medtronic Complete® Self-Expanding Stent and Stent Delivery System Registry: a Non-randomized Prospective, Multicenter, Consecutive Registry

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to show if a new delivery system with a modified stent is safe in treating occluded iliac arteries in patients with peripheral vascular disease. The modified Complete SE delivery system is hypothesized to assist physicians with more accurate stent placement reducing the likelihood of stent 'jumping' seen with the use of many self-expanding stent systems.

Detailed description

The study is being conducted to collect the 30-day safety data on the stent delivery system for all subjects enrolled into the study (with a minimum of 50 subjects enrolled) as well as the long-term 9-month safety and efficacy data on all subjects enrolled (with a minimum of 10 subjects enrolled into the study having the 120mm length stent implanted).

Conditions

• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	Complete SE Iliac Stent	Iliac stenting
DEVICE	Complete SE Iliac Stent	Self-expanding stent

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-02-01
• Completion: 2012-08-01
• First posted: 2008-08-08
• Last updated: 2016-04-04
• Results posted: 2011-03-11

Locations

2 sites across 1 country: United States