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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Flanders Medical Research Program
ClinicalTrials.gov Identifier:
NCT01412450
First received: July 2, 2010
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412450

Locations
Belgium
Imeldaziekenhuis
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
Investigators
Principal Investigator: Marc Bosiers, MD A.Z. Sint-Blasius
  More Information

No publications provided

Responsible Party: Flanders Medical Research Program
ClinicalTrials.gov Identifier: NCT01412450     History of Changes
Other Study ID Numbers: FMRP-100702
Study First Received: July 2, 2010
Last Updated: September 30, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases
Menthol
Antipruritics
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014