NCT01643746

Evaluation of Luminal Expansion Following Stenting of Femoro-popliteal Occlusive Disease

C-arm CT Evaluation of Luminal Expansion in Stenting Severe Femoro-popliteal Atherosclerotic Disease: Supera Versus LifeStent

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary goal of this trial is to compare prospectively stent opening of Supera (IDEV Technologies) versus a reference stent (LifeStent, Bard Medical) using C-arm CT. A secondary goal is to correlate stent opening with stent patency as documented by Doppler ultrasound at one year post implantation.

Conditions

• Femoropopliteal Stenosis

Interventions

Type	Name	Description
DEVICE	Supera Stent	Angioplasty and stenting will performed according to the guidelines of the Society of Interventional Radiology and the instruction for use for each stent. Patients will be allocated to Supera stent versus LifeStent based on block randomization (block size 4 patients).
DEVICE	Life Stent	Angioplasty and stenting will performed according to the guidelines of the Society of Interventional Radiology and the instruction for use for each stent. Patients will be allocated to Supera stent versus LifeStent based on block randomization (block size 4 patients).

Timeline

• Start date: 2017-12-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2012-07-18
• Last updated: 2018-07-20

Locations

2 sites across 1 country: Canada

Regulatory

• FDA-regulated device study