NCT01071460

Evaluation of Efficacy and Safety of the FlexStent Self-Expanding Stent System

The FlexStent-Registry, Evaluation of Efficacy and Safety of the FlexStent Femoropopliteal Self-Expanding Stent System

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Provascular GmbH · Academic / Other
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Purpose of this registry is to determine the efficacy and safety of the self-expanding, extra flexible FlexStent in patient with superficial femor/popliteal artery disease. The stent has been developed to cope with the extreme requirements of the femoral artery/knee artery and is approved for usage at humans (EC-certified). It is designed to treat narrows of the femoral- and knee artery. 100 patients at 5 German hospital shall be enrolled. After stent implantation follow-up visits at 6 and 12 month take place.

Detailed description

Peripheral arterial disease (PAD) represents a major challenge to physicians in treating the Superficial Femoral (SFA) and Popliteal arteries. These arteries represent a harsh environment for any endovascular device. This disease is characterized by long occlusions with relatively low flow and with the vessels exposed to enormous mechanical stress. During flexing of the knee, the SFA/Popliteal arteries can bend, rotate, elongate and compress dramatically. An ideal stent designed for use in the SFA/Popliteal arteries would offer great ranges of movement while adequately supporting the arteries. The FlexStent® stent provides a great range of motions for a highly flexible femoral artery while adequately supporting the vessel. The intended use for the FlexStent® stent is for the treatment of symptomatic femoropopliteal disease, primarily for atherosclerotic de novo native superficial femoral artery lesions. The intent of this clinical registry is to demonstrate the efficacy and safety of the FlexStent® stent in patients with superficial femoral/ popliteal artery disease. Hypothesis: the FlexStent® will be safe and efficacious in treating SFA/popliteal artery diseases. Primary object: evaluation of efficacy of the FlexStent® measured by the in-stent restenosis using DUS following treatment, 6 and 12 MFU visits.

Conditions

• Efficacy of the Study Device

Interventions

Type	Name	Description
DEVICE	FlexStent Femoropopliteal Self-Expanding Stent System	Peri-procedural management will be no different to routine SFA/Popliteal Artery intervention Standard medical therapy Procedural techniques will be identical to routine protocols for SFA/Popliteal Artery stenting. technique suggested: * Contralateral retrograde common femoral cross-over access or antegrade access * Target lower limb arteries fully imaged angiogram. with measurement of SFA/Popliteal Artery target lesion length and normal vessel diameter immediately above and below target lesion * Pre-stenting balloon dilatation of target lesion in all total occlusions and critical stenosis * Deployment of an appropriately sized FlexStent® to cover target lesion * Post-stent balloon dilate stent using a semi-compliant angioplasty balloon to enable accurate post-dilatation of stent to target diameter * Post stenting angiography assessing target lesion parameters, run-off vessel patency and complications

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-02-19
• Last updated: 2012-11-09

Locations

3 sites across 1 country: Germany