NCT02066740

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 16, 2015

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

February 16, 2014

Results QC Date

August 7, 2015

Last Update Submit

February 14, 2019

Conditions

Peripheral Arterial Diseases

Keywords

Superficial Femoral ArteryProximal Popliteal ArteryEverflexEntruststent

Outcome Measures

Primary Outcomes (2)

  • Absence of Stent Elongation

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

    Intra operative

  • Successful Stent Deployment

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

    Procedure

Study Arms (1)

EverFlex™ stent with Entrust™ delivery system

EXPERIMENTAL
Device: EverFlex™ stent with Entrust™ delivery system

Interventions

EverFlex™ stent with Entrust™ delivery systemDEVICE
EverFlex™ stent with Entrust™ delivery system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Weiden

Weiden, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Results Point of Contact

Title
Stephanie Cihlar
Organization
Medtronic
stephanie.a.cihlar@medtronic.com
763-398-7932

Study Officials

  • Carl M Wahlgren, MD/PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2014

First Posted

February 19, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 1, 2019

Results First Posted

September 16, 2015

Record last verified: 2019-02

Locations

DE(1)