Status:
COMPLETED
Efficacity Study With the Protégé EverFlex Stent in Popliteal Lesions
Lead Sponsor:
Flanders Medical Research Program
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 w...
Eligibility Criteria
Inclusion
- General 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
- Angiographic Inclusion Criteria
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01412450
Start Date
July 1 2010
End Date
August 1 2012
Last Update
October 1 2013
Active Locations (4)
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1
Imeldaziekenhuis
Bonheiden, Antwerp, Belgium, 2820
2
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
3
A.Z. Sint-Blasius
Dendermonde, East-Flanders, Belgium, 9200
4
Heilig-Hart Ziekenhuis
Tienen, Flemish Brabant, Belgium, 3300