Clinical trial NCT01412463: DURABILITY+ : a Prospective, Multi-center, Controlled Study With the Everflex+ Stent in SFA Lesions
Official title: DURABILITY+ : a Prospective, Multi-center, Controlled Study Measuring the Durability in Lesions of the Superficial Femoral Artery of the Protégé Everflex+ Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
Collaborators: name: Medtronic Neurovascular Clinical Affairs
First posted: 2011-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Major Adverse Event rate
timeFrame: 30 days post-procedure
measure: Primary stent patency
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Technical success
timeFrame: 1 day post-procedure
measure: Primary stent patency at 1 and 6 months
timeFrame: 1 and 6 months post-procedure
measure: Primary assisted patency
timeFrame: 1, 6 and 12 months post-procedure
measure: Secondary patency
timeFrame: 1, 6 and 12 months post-procedure
measure: Target lesion revascularization
timeFrame: 12 months post-procedure
measure: limb-salvage
timeFrame: 12-months post-procedure
measure: Clinical success
timeFrame: 1, 6 and 12 months post-procedure
measure: Serious adverse events
timeFrame: 12-months post-procedure
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
state: Antwerp
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
city: Dendermonde
country: Belgium
facility: A.Z. Sint-Blasius
state: East-Flanders
Study officials:
References: