Physician Initiated Trial Investigating the Efficacy of the Implant of EverFlex 200mm Long Nitinol Stents in TASC C&D Femoropopliteal Lesions

Flanders Medical Research Program2 sites in 1 country100 target enrollmentMarch 2008

ConditionsPeripheral Vascular Disease Intermittent Claudication Critical Limb Ischemia

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Peripheral Vascular Disease
Sponsor: Flanders Medical Research Program
Enrollment: 100
Locations: 2
Primary Endpoint: Primary patency defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without TLR
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this clinical investigation is to evaluate the long-term (up to 12 months) outcome of the 200 mm long self-expanding nitinol EverFlex (ev3) stent in long femoropopliteal lesions (TASC C & D) Is is the first time that the use of 200 mm long stents will be evaluated in these lesions. It is expected that the outcome of the treatment with this type of long stents will be better as the treatment of identical lesions lengths with multiple shorter stents.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

November 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Flanders Medical Research Program

Eligibility Criteria

Inclusion Criteria

•De novo, restenotic or reoccluded lesion located in the femoropopliteal arteries suitable for stenting
•Patient presenting a score from 2 to 5 following Rutherford classification
•Patient is willing to comply with specified follow-up evaluations at the specified times
•Patient is \>18 years old
•Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
•Prior to enrollment, the guidewire has crossed target lesion
•Patient is eligible for treatment with the self-expanding nitinol EverFlex (ev3) stent
•ANGIOGRAPHIC
•The target lesion is located within the native femoropopliteal artery until maximally 3 cm proximally of the knee joint.
•The target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion which can be passed with standard guidewire manipulation

Exclusion Criteria

•Presence of another stent in the target vessel that was placed during a previous procedure
•Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
•Previous by-pass surgery in the same limb
•Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
•Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
•Perforation at the angioplasty site evidenced by extravasation of contrast medium
•Patients with known hypersensitivity to nickel-titanium
•Patients with uncorrected bleeding disorders
•Aneurysm located at the level of the SFA
•Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding

Outcomes

Primary Outcomes

Primary patency defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without TLR

Time Frame: 12 months

Secondary Outcomes

Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging.(procedure)
Primary patency defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without TLR(6 months)
Clinical success at follow-up defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure(6 & 12 months)
Stent fracture rate determined on x-ray (Mild - single strut fracture; Moderate - fracture of more than one strut but without complete separation; Severe - complete separation)(12 months)
Serious adverse events(12 months)