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DURABILITY+ : a Prospective, Multi-center, Controlled Study With the Everflex+ Stent in SFA Lesions

NCT01412463 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-10-01

No results posted yet for this study

Summary

The objective of this study is to evaluate the immediate and long-term (up to 12 months) safety and effectiveness of primary stenting with the Protégé Everflex+ stent system for the treatment of superficial femoral artery (SFA) lesions (without involvement of the popliteal artery) between 40 mm and 180 mm in length.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

stent placement

* pre-dilation of the study lesion is mandatory * stent placement with 1 Protégé Everflex+ stent * only 1 stent is allowed within the study protocol * post-dilation may be performed but is not mandatory

Sponsors & Collaborators

  • Medtronic Neurovascular Clinical Affairs

    collaborator INDUSTRY

  • Flanders Medical Research Program

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Belgium

Study Locations

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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 NCT01412463 on ClinicalTrials.gov