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

NCT ID: NCT02066740

Last Updated: 2019-03-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-07-31

Brief Summary

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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

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Conditions

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Peripheral Arterial Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EverFlex™ stent with Entrust™ delivery system

Group Type EXPERIMENTAL

EverFlex™ stent with Entrust™ delivery system

Intervention Type DEVICE

Interventions

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EverFlex™ stent with Entrust™ delivery system

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Endovascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl M Wahlgren, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Klinikum Weiden

Weiden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CP1007

Identifier Type: -

Identifier Source: org_study_id

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