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Efficacity Study With the Protégé EverFlex Stent in Popliteal Lesions (DUR-POP)

This study has been completed.
Information provided by (Responsible Party):
Flanders Medical Research Program Identifier:
First received: July 2, 2010
Last updated: September 30, 2013
Last verified: September 2013
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.

Condition Intervention Phase
Peripheral Arterial Disease
Device: nitinol stent
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DURABILITY-POP Study - Physician Initiated Trial Investigating the Efficacy of the Implant of Protégé EverFlex Nitinol Stents in Popliteal Lesions

Resource links provided by NLM:

Further study details as provided by Flanders Medical Research Program:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Technical success [ Time Frame: 1 day post-procedure ]
    Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging

  • Primary patency rate at 6-, 12-month follow-up. [ Time Frame: 6-, 12-month follow-up ]
    Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent.

  • Clinical success [ Time Frame: 6-, 12-month follow-up ]
    Clinical success at follow-up is defined as an improvement of Rutherford classification at 6-, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.

  • tent fracture rate at 12-month follow-up [ Time Frame: 12-month follow-up ]
    Determined according the following classification on x-ray: Class 0 (no strut factures); Class I (single tine fracture); Class II (multiple tine factures); Class III (Stent fracture(s) with preserved alignment of the components); Class IV (Stent fracture(s) with mal-alignment of the components); Class V (Stent fracture(s) in a trans-axial spiral configuration)

  • Serious adverse events [ Time Frame: 1 year ]
    Defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.

Enrollment: 60
Study Start Date: July 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nitinol stent
Protégé EverFlex stent
Device: nitinol stent
implantation of one Protégé EverFlex stent
Other Name: Protégé EverFlex stent


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01412450

Bonheiden, Antwerp, Belgium, 2820
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
A.Z. Sint-Blasius
Dendermonde, East-Flanders, Belgium, 9200
Heilig-Hart Ziekenhuis
Tienen, Flemish Brabant, Belgium, 3300
Sponsors and Collaborators
Flanders Medical Research Program
Principal Investigator: Marc Bosiers, MD A.Z. Sint-Blasius
  More Information

Responsible Party: Flanders Medical Research Program Identifier: NCT01412450     History of Changes
Other Study ID Numbers: FMRP-100702
Study First Received: July 2, 2010
Last Updated: September 30, 2013

Keywords provided by Flanders Medical Research Program:
symptomatic popliteal artery stenosis or occlusion

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Dermatologic Agents processed this record on April 28, 2017