MedTrace Logo

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

NCT01071460 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-11-09

No results posted yet for this study

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.

Conditions

  • Efficacy of the Study Device

Interventions

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

Sponsors & Collaborators

  • Provascular GmbH

    lead OTHER

Principal Investigators

  • Dierk Scheinert, Professor · Park-Krankenhaus Leipzig

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01071460 on ClinicalTrials.gov