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

N/ACompletedNCT02066740

Medtronic Endovascular34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Diseases

Interventions

EverFlex™ stent with Entrust™ delivery systemDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Klinikum Weiden

Weiden, Germany

Outcomes

Primary Outcomes

Absence of Stent Elongation

Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length

Time frame: Intra operative

Successful Stent Deployment

Successful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment.

Time frame: Procedure

Data from ClinicalTrials.gov

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