EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study

Not Applicable

Completed

• Conditions: Peripheral Arterial Diseases
• Interventions: Device: EverFlex™ stent with Entrust™ delivery system

• Registration Number: NCT02066740
• Lead Sponsor: Medtronic Endovascular

Brief Summary

The purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-16
• Study First Submitted QC: 2014-02-18
• Study First Posted: 2014-02-19
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2015-08-07
• Results First Submitted QC: 2015-08-14
• Results First Posted: 2015-09-16
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts),
• or occluded lesion(s) located in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) suitable for primary stenting.

Exclusion Criteria

• Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EverFlex™ stent with Entrust™ delivery system	EverFlex™ stent with Entrust™ delivery system	-

Primary Outcome Measures

Name	Time	Method
Absence of Stent Elongation	Intra operative	Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length
Successful Stent Deployment	Procedure	Successful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment.

Trial Locations

Locations (1)

Klinikum Weiden; 🇩🇪 Weiden, Germany