Status:
COMPLETED
DURABILITY+ : a Prospective, Multi-center, Controlled Study With the Everflex+ Stent in SFA Lesions
Lead Sponsor:
Flanders Medical Research Program
Collaborating Sponsors:
Medtronic Neurovascular Clinical Affairs
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 super...
Eligibility Criteria
Inclusion
- General
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01412463
Start Date
May 1 2011
End Date
January 1 2013
Last Update
October 1 2013
Active Locations (3)
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1
Imelda Hospital
Bonheiden, Antwerp, Belgium, 2820
2
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
3
A.Z. Sint-Blasius
Dendermonde, East-Flanders, Belgium, 9200