Efficacity Study With the Protégé EverFlex Stent in Popliteal Lesions

NCT ID: NCT01412450

Last Updated: 2013-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-08-31

Brief Summary

This study will assess the results up to 12 months with the Protégé EverFlex stent (ev3) in patients presenting with a narrowing or blocking at the level of the knee artery, which leads to a limited walking distance, rest pain or non-healing ulcers.

Conditions

Peripheral Arterial Disease

Keywords

symptomatic popliteal artery stenosis or occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nitinol stent

Protégé EverFlex stent

Group Type: EXPERIMENTAL

nitinol stent

Intervention Type: DEVICE

implantation of one Protégé EverFlex stent

Interventions

nitinol stent

implantation of one Protégé EverFlex stent

Intervention Type: DEVICE

Other Intervention Names

Protégé EverFlex stent

Eligibility Criteria

Inclusion Criteria

• De novo, restenotic or reoccluded lesion located in the popliteal artery, with or without superficial femoral artery involvement
• 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

• The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation
• The target lesion, visually estimated, has a maximal length of 14 cm and can be categorized as either a type A or B lesions according the TASC II guidelines
• Target vessel diameter visually estimated is >3.5mm and <7.5 mm
• There is angiographic evidence of at least one-vessel-runoff to the foot

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 and/or popliteal artery
• Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
• Life expectancy of less than twelve months
• Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis > 30% or ipsilateral iliac treatment conducted after the target lesion procedure
• Use of thrombectomy, artherectomy or laser devices during procedure
• Any patient considered to be hemodynamically unstable at onset of procedure
• Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Flanders Medical Research Program

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Bosiers, MD

Role: PRINCIPAL_INVESTIGATOR

A.Z. Sint-Blasius

Locations

Imeldaziekenhuis

Bonheiden, Antwerp, Belgium

University Hospital Antwerp

Edegem, Antwerp, Belgium

A.Z. Sint-Blasius

Dendermonde, East-Flanders, Belgium

Heilig-Hart Ziekenhuis

Tienen, Flemish Brabant, Belgium

Countries

Belgium

Other Identifiers

FMRP-100702

Identifier Type: -

Identifier Source: org_study_id