EVOLUTION STUDY, a Physician-inititated Trial Investigating the Efficacy of the Self-Expanding iVolution Nitinol Stent for Treatment of Femoropopliteal Lesions

Flanders Medical Research Program4 sites in 1 country120 target enrollmentApril 2015

ConditionsPeripheral Arterial Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: Flanders Medical Research Program
Enrollment: 120
Locations: 4
Primary Endpoint: Primary Patency at 12 months
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this clinical investigation is to evaluate the short-term (up to 12 months) outcome of treatment by means of the self-expanding iVolution nitinol stent in symptomatic (Rutherford 2-4) femoropopliteal arterial stenotic or occlusive lesions.

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

December 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Flanders Medical Research Program

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•De novo lesion located in the femoropopliteal arteries suitable for endovascular treatment
•Patient presenting with a score from 2 to 4 according to the Rutherford classification
•Patient is willing and able to comply with specified follow-up evaluations at the predefined time intervals
•Patient is \>18 years old
•Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
•Prior to enrollment, the target lesion was crossed with standard guidewire manipulation One target lesion is located within the native SFA: distal point 3 cm above knee joint
•The target lesion has angiographic evidence of stenosis or occlusion
•Length of the target lesion is ≤ 15 cm by visual estimation
•Target vessel diameter visually estimated is ≥4 mm and ≤7 mm
•There is angiographic evidence of at least one vessel-runoff to the foot

Exclusion Criteria

•Presence of a stent in the target vessel that was placed during a previous procedure
•Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
•Previous bypass surgery in the same limb
•Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
•Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
•Perforation at the angioplasty site evidenced by extravasation of contrast medium
•Patients with known hypersensitivity to nickel-titanium or other study device components
•Patients with uncorrected bleeding disorders
•Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
•Life expectancy of less than 12 months

Outcomes

Primary Outcomes

Primary Patency at 12 months

Time Frame: 12 months

freedom from \>50% restenosis at 12 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) \<2.5 in the target vessel with no reintervention

Secondary Outcomes

Primary Patency at 1 & 6 months(1 & 6 months)
Technical Success(Procedure)
Freedom from Target Lesion Revascularization (TLR) at 1, 6 and 12 months(at all follow-up visits)
Serious adverse events until follow-up completions(1,6,12 months and interem visits)
Clinical Success at 1, 6 and 12 months(at all follow-up visits)