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

This study has been completed.
Sponsor:
Information provided by:
Flanders Medical Research Program
ClinicalTrials.gov Identifier:
NCT00637741
First received: March 12, 2008
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Peripheral Vascular Disease
Intermittent Claudication
Critical Limb Ischemia
Device: Everflex 200
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Flanders Medical Research Program:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Serious adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: March 2008
Study Completion Date: November 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everflex 200
study group treated with at least one 200 mm Everflex stent
Device: Everflex 200
-

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

GENERAL

  • 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

ANGIOGRAPHIC

  • 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.
  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: NCT00637741

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

Additional Information:
No publications provided by Flanders Medical Research Program

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Flanders Medical Research Program (FMRP)
ClinicalTrials.gov Identifier: NCT00637741     History of Changes
Other Study ID Numbers: FMRP-004
Study First Received: March 12, 2008
Last Updated: November 30, 2010
Health Authority: Belgium: Institutional Review Board

Keywords provided by Flanders Medical Research Program:
Peripheral Vascular Disease
Intermittent claudication
Critical Limb Ischemia
TASC

Additional relevant MeSH terms:
Intermittent Claudication
Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Pathologic Processes
Signs and Symptoms
Menthol
Antipruritics
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014