DURABILITY-200: EverFlex 200mm Long Nitinol Stents in TASC C&D Femoropopliteal Lesions
This study has been completed.
Sponsor:
Flanders Medical Research Program
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
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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
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 Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Arteriosclerosis Arterial Occlusive Diseases Cardiovascular Diseases |
Signs and Symptoms Pathologic Processes Atherosclerosis Menthol Antipruritics Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013