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

Flanders Medical Research Program

Status and phase

Completed

Phase 4

Conditions

Peripheral Arterial Disease

Treatments

Device: stent placement

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT01412463

FMRP-101208

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

General 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

Angiographic Inclusion Criteria

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

General 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.

Angiographic Exclusion Criteria

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