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DURABILITY-200: EverFlex 200mm Long Nitinol Stents in TASC C&D Femoropopliteal Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00637741
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : December 1, 2010
Information provided by:
Flanders Medical Research Program

Brief Summary:
The objective of this clinical investigation is to evaluate the long-term (up to 12 months) outcome of the 200 mm long self-expanding nitinol EverFlex (ev3) stent in long femoropopliteal lesions (TASC C & D) Is is the first time that the use of 200 mm long stents will be evaluated in these lesions. It is expected that the outcome of the treatment with this type of long stents will be better as the treatment of identical lesions lengths with multiple shorter stents.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Intermittent Claudication Critical Limb Ischemia Device: Everflex 200 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physician Initiated Trial Investigating the Efficacy of the Implant of EverFlex 200mm Long Nitinol Stents in TASC C&D Femoropopliteal Lesions
Study Start Date : March 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Menthol

Arm Intervention/treatment
Experimental: Everflex 200
study group treated with at least one 200 mm Everflex stent
Device: Everflex 200

Primary Outcome Measures :
  1. Primary patency defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without TLR [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: procedure ]
  2. Primary patency defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without TLR [ Time Frame: 6 months ]
  3. Clinical success at follow-up defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure [ Time Frame: 6 & 12 months ]
  4. Stent fracture rate determined on x-ray (Mild - single strut fracture; Moderate - fracture of more than one strut but without complete separation; Severe - complete separation) [ Time Frame: 12 months ]
  5. Serious adverse events [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:


  • De novo, restenotic or reoccluded lesion located in the femoropopliteal arteries suitable for stenting
  • 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


  • The target lesion is located within the native femoropopliteal artery until maximally 3 cm proximally of the knee joint.
  • 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 minimal length of 15 cm and can be categorized as either a type C or D lesions according the TASC II guidelines
  • Target vessel diameter visually estimated is >4mm and <6.5 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
  • 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 planned surgical intervention/procedure within 30 days of the study 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00637741

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Imelda Hospital
Bonheiden, Belgium, 2820
AZ Sint-Blasius
Dendermonde, Belgium, 9200
Sponsors and Collaborators
Flanders Medical Research Program
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Principal Investigator: Marc Bosiers, MD AZ Sint-Blasius, Dendermonde, Belgium

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Flanders Medical Research Program (FMRP) Identifier: NCT00637741     History of Changes
Other Study ID Numbers: FMRP-004
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: December 1, 2010
Last Verified: November 2010
Keywords provided by Flanders Medical Research Program:
Peripheral Vascular Disease
Intermittent claudication
Critical Limb Ischemia
Additional relevant MeSH terms:
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Vascular Diseases
Intermittent Claudication
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases
Signs and Symptoms
Dermatologic Agents