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

NCT ID: NCT00637741

Last Updated: 2010-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2010-11-30

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.

Conditions

Peripheral Vascular Disease; Intermittent Claudication; Critical Limb Ischemia

Keywords

Peripheral Vascular Disease; Intermittent claudication; Critical Limb Ischemia; TASC

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Everflex 200

study group treated with at least one 200 mm Everflex stent

Group Type: EXPERIMENTAL

Everflex 200

Intervention Type: DEVICE

Interventions

Everflex 200

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Flanders Medical Research Program

NETWORK

Sponsor Role: lead

Responsible Party

Flanders Medical Research Program (FMRP)

Principal Investigators

Marc Bosiers, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Blasius, Dendermonde, Belgium

Locations

Imelda Hospital

Bonheiden, , Belgium

AZ Sint-Blasius

Dendermonde, , Belgium

Countries

Belgium

References

Bosiers M, Deloose K, Callaert J, Moreels N, Keirse K, Verbist J, Peeters P. Results of the Protege EverFlex 200-mm-long nitinol stent (ev3) in TASC C and D femoropopliteal lesions. J Vasc Surg. 2011 Oct;54(4):1042-50. doi: 10.1016/j.jvs.2011.03.272. Epub 2011 Jun 2.

Reference Type: DERIVED

PMID: 21636239 (View on PubMed)

Other Identifiers

FMRP-004

Identifier Type: -

Identifier Source: org_study_id