NCT01412450CompletedPhase 4
DURABILITY-POP Study - Physician Initiated Trial Investigating the Efficacy of the Implant of Protégé EverFlex Nitinol Stents in Popliteal Lesions
Flanders Medical Research Program8 sites in 1 country60 target enrollmentStarted: July 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 60
- Locations
- 8
- Primary Endpoint
- primary patency
Study Overview
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 walking distance, rest pain or non-healing ulcers.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
primary patency
Time Frame: 12 months post-procedure
primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without TLR within 12 months
Secondary Outcomes
- Technical success(1 day post-procedure)
- Primary patency rate at 6-, 12-month follow-up.(6-, 12-month follow-up)
- Clinical success(6-, 12-month follow-up)
- tent fracture rate at 12-month follow-up(12-month follow-up)
- Serious adverse events(1 year)
Investigators
Study Sites (8)
Loading locations...
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