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

Primary Purpose

Peripheral Arterial Diseases

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

EverFlex™ stent with Entrust™ delivery system

About this trial

This is an interventional treatment trial for Peripheral Arterial Diseases focused on measuring Superficial Femoral Artery, Proximal Popliteal Artery, Everflex, Entrust, stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Klinikum Weiden

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EverFlex™ stent with Entrust™ delivery system

Arm Description

Outcomes

Primary Outcome Measures

Absence of Stent Elongation

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

Successful Stent Deployment

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02066740

First Posted

February 16, 2014

Last Updated

February 14, 2019

Sponsor

Medtronic Endovascular

1. Study Identification

Unique Protocol Identification Number

NCT02066740

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Endovascular

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Diseases

Keywords

Superficial Femoral Artery, Proximal Popliteal Artery, Everflex, Entrust, stent

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EverFlex™ stent with Entrust™ delivery system

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

EverFlex™ stent with Entrust™ delivery system

Primary Outcome Measure Information:

Title

Absence of Stent Elongation

Description

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

Time Frame

Intra operative

Title

Successful Stent Deployment

Description

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

Time Frame

Procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carl M Wahlgren, MD/PhD

Organizational Affiliation

Karolinska University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinikum Weiden

City

Weiden

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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