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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02066740
Enrollment
34
Registered
2014-02-19
Start date
2014-02-28
Completion date
2014-07-31
Last updated
2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Diseases

Keywords

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

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.

Interventions

DEVICEEverFlex™ stent with Entrust™ delivery system

Sponsors

Medtronic Endovascular
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Absence of Stent ElongationIntra operativeAbsence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length
Successful Stent DeploymentProcedureSuccessful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment.

Countries

Germany

Participant flow

Participants by arm

ArmCount
EverFlex™ Stent With Entrust™ Delivery System
EverFlex™ stent with Entrust™ delivery system
34
Total34

Baseline characteristics

CharacteristicEverFlex™ Stent With Entrust™ Delivery System
Age, Continuous71.5 years
STANDARD_DEVIATION 9.4
Region of Enrollment
Germany
27 participants
Region of Enrollment
Sweden
7 participants
Sex: Female, Male
Female
17 Participants
Sex: Female, Male
Male
17 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 34
serious
Total, serious adverse events
4 / 34

Outcome results

Primary

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

ArmMeasureValue (NUMBER)
EverFlex™ Stent With Entrust™ Delivery SystemAbsence of Stent Elongation95.6 percentage absence of stent elongation
Primary

Successful Stent Deployment

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

Time frame: Procedure

ArmMeasureValue (NUMBER)
EverFlex™ Stent With Entrust™ Delivery SystemSuccessful Stent Deployment100.0 percentage - successful stent deployment

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026