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

Medtronic

Status: Completed

Conditions: Peripheral Arterial Diseases

Treatments: Device: EverFlex™ stent with Entrust™ delivery system

Study type: Interventional

Funder types: Industry

Identifiers

NCT02066740

CP1007

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

EverFlex™ stent with Entrust™ delivery system

Experimental group

Treatment:

Device: EverFlex™ stent with Entrust™ delivery system