DURABILITY+ : a Prospective, Multi-center, Controlled Study With the Everflex+ Stent in SFA Lesions

NCT ID: NCT01412463

Last Updated: 2013-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-01-31

Brief Summary

The objective of this study is to evaluate the immediate and long-term (up to 12 months) safety and effectiveness of primary stenting with the Protégé Everflex+ stent system for the treatment of superficial femoral artery (SFA) lesions (without involvement of the popliteal artery) between 40 mm and 180 mm in length.

Conditions

Peripheral Arterial Disease

Study Design

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

Study Groups

Protégé EverFlex+

Stenting with Protégé EverFlex+

Group Type: EXPERIMENTAL

stent placement

Intervention Type: DEVICE

• pre-dilation of the study lesion is mandatory
• stent placement with 1 Protégé Everflex+ stent
• only 1 stent is allowed within the study protocol
• post-dilation may be performed but is not mandatory

Interventions

stent placement

• pre-dilation of the study lesion is mandatory
• stent placement with 1 Protégé Everflex+ stent
• only 1 stent is allowed within the study protocol
• post-dilation may be performed but is not mandatory

Intervention Type: DEVICE

Other Intervention Names

Protégé EverFlex+

Eligibility Criteria

Inclusion Criteria

• De novo, restenotic or reoccluded (from PTA or adjunct therapy, not including stents or stent grafts) lesion located in the superficial femoral artery (without popliteal involvement) with proximal point at least one centimeter below the origin of the profunda femoralis and suitable for stenting
• Patient presenting with a score from 2 to 4 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 enrollment in the study

• The length of the target lesion is minimally 40 mm and maximally 180 mm, to be covered with one stent
• The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation
• Target vessel diameter visually estimated is >3.5 mm and <7.5 mm
• Prior to enrollment, the guidewire has crossed target lesion
• There is angiographic evidence of at least one-vessel-runoff to the foot, irrespective of whether or not outflow was re-established by means of previous endovascular intervention
• Patient is eligible for treatment with the Protégé Everflex+ stent system

Exclusion Criteria

• Presence of another stent or stent graft in the target vessel that was placed during a previous procedure
• Previous by-pass surgery in the same limb requiring access to the target lesion
• Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated or no alternative is available
• Patients with known hypersensitivity to nickel-titanium
• Patients with uncorrected bleeding disorders
• Female patient with child bearing potential not using adequate contraceptives or currently breastfeeding
• Life expectancy of less than twelve months
• Use of thrombectomy, artherectomy, cryoplasty, cutting balloon, drug-eluting balloon, embolic protection 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.

• Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
• Patients who exhibit persistent acute intraluminal thrombus of the proposed target lesion site
• Perforation, dissection or other injury of the access site or target vessel requiring additional stenting or surgical intervention prior to start of the index procedure
• Perforation at the angioplasty site evidenced by extravasation of contrast medium
• Aneurysm located at the level of the SFA and/or proximal popliteal

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

Sponsors

Medtronic Neurovascular Clinical Affairs

INDUSTRY

Sponsor Role: collaborator

Flanders Medical Research Program

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Imelda Hospital

Bonheiden, Antwerp, Belgium

University Hospital Antwerp

Edegem, Antwerp, Belgium

A.Z. Sint-Blasius

Dendermonde, East-Flanders, Belgium

Countries

Belgium

Other Identifiers

FMRP-101208

Identifier Type: -

Identifier Source: org_study_id