Clinical trial NCT01108861: GORE VIABAHN® Versus Plain Old Balloon Angioplasty (POBA) for Superficial Femoral Artery (SFA) In-Stent Restenosis
Official title: The GORE VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Versus Plain Old Balloon Angioplasty (POBA) for the Treatment of Superficial Femoral Artery (SFA) In-Stent Restenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Vascular Disease
Keywords: Peripheral Vascular Disease
In-stent restenosis
Endoprosthesis
Plain old balloon angioplasty
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
First posted: 2010-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, multi-center study recruiting patients with an in-stent restenosis in the superficial femoral artery. The safety and efficacity of the Viabahn endoprosthesis (W.L. Gore \& Associates), a heparin-bonded endoprosthesis, is compared with plain old balloon angioplasty (POBA). In 4 Belgian and 2 German centers a total of 80 Patients will be recruited. Primary endpoint is primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (CFDU) measuring a peak systolic velocity ratio ≤2.5, and without target lesion revascularization (TLR) within 12 months.

In comparison to POBA, it is expected that the use of the Viabahn endoprosthesis (W.L. Gore \& Associates) will result in greater 12 month primary patency of treated superficial femoral artery in-stent restenotic lesions.


Eligibility criteria: General Inclusion Criteria:

* Patient presenting with lifestyle-limiting claudication, rest pain or minor tissue loss (Rutherford classification from 2 to 5)
* Patient is willing to comply with specified follow-up evaluations at the specified times
* Patient is \>18 years old
* Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
* Patient has a projected life-expectancy of at least 24 months
* Noninvasive lower extremity arterial studies (resting or exercise) demonstrate ankle-brachial index ≤0.8
* Patient is eligible for treatment with the Viabahn® Endoprosthesis (W.L. Gore)
* Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure

Angiographic Inclusion Criteria

* Restenotic or reoccluded lesion located in a stent which was previously implanted (\>30 days) in the superficial femoral artery, suitable for endovascular therapy
* Total target lesion length between 4 and 27 cm (comprising in-stent restenosis and adjacent stenotic disease)
* Minimum of 1.0cm of healthy vessel (non-stenotic) both proximal and distal to the treatment area
* Popliteal artery is patent at the intercondylar fossa of the femur to P3
* Target vessel diameter visually estimated to be \>4mm and \<7.6 mm at the proximal and distal treatment segments within the SFA
* Guidewire and delivery system successfully traversed lesion
* There is angiographic evidence of at least one-vessel-runoff to the foot, that does not require intervention (\<50% stenotic)

Exclusion criteria :

* Untreated flow-limiting aortoiliac stenotic disease
* Presence of a chronic total occlusion, i.e. a complete occlusion of the failed bare stent that cannot be re-opened with thrombolysis or does not allow easy passage of the guidewire by the physician
* Any previous surgery in the target vessel
* Severe ipsilateral common/deep femoral disease requiring surgical reintervention
* Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
* Femoral or popliteal aneurysm located at the target vessel
* Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
* No patent tibial arteries (\>50% stenosis)
* Prior ipsilateral femoral artery bypass
* Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 2-year life expectancy
* Serum creatinine \>2.5mg/dL within 45 days prior to study procedure unless the subject is currently on dialysis
* Major distal amputation (above the transmetatarsal) in the study or non-study limb
* Septicemia or bacteremia
* Any previously known coagulation disorder, including hypercoagulability
* Contraindication to anticoagulation or antiplatelet therapy
* Known allergies to stent or stent graft components (nickel-titanium or ePTFE)
* Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
* Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
* Currently participating in another clinical research trial, unless approved by W.L. Gore \& Associates in advance of study enrolment
* Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment
* Any planned surgical intervention/procedure within 30 days of the study procedure
* Target lesion access not performed by transfemoral approach.

Primary outcomes:
measure: Primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (CFDU) and without target lesion revascularization (TLR) within 12 months.
timeFrame: 1 year
measure: Proportion of subjects who experience serious device-related adverse events within 30 days post-procedure
timeFrame: 30 days
Secondary outcomes:
measure: Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.
timeFrame: during procedure
measure: Hemodynamic primary patency rate at 1, 6, 12, 24-month follow-up.
timeFrame: 1, 6, 12, 24-month follow-up
measure: Angiographic primary patency at 12 months
timeFrame: 1 year
measure: Primary assisted patency rate at 1, 6, 12, 24-month follow-up.
timeFrame: 1, 6, 12, 24-month follow-up
measure: Secondary patency rate at 1, 6, 12, 24-month follow-up
timeFrame: 1, 6, 12, 24-month follow-up
measure: Target lesion revascularization (TLR)
timeFrame: entire follow-up
measure: Clinical success at follow-up
timeFrame: at 1 day and 1, 6, 12, 24-month follow-up
measure: Serious adverse events
timeFrame: during entire follow-up
measure: Stent fracture rate at 12 months
timeFrame: 1 year
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Edegem
country: Belgium
facility: Universitair ziekenhuis antwerpen
city: Genk
country: Belgium
facility: Zuid Oost Limburg
city: Bad Krozingen
country: Germany
facility: Herz-zentrum Bad Krozingen
city: Leipzig
country: Germany
facility: Herzzentrum
Study officials:
affiliation: AZ Sint Blasius
name: Marc Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bosiers M, Deloose K, Callaert J, Verbist J, Hendriks J, Lauwers P, Schroe H, Lansink W, Scheinert D, Schmidt A, Zeller T, Beschorner U, Noory E, Torsello G, Austermann M, Peeters P. Superiority of stent-grafts for in-stent restenosis in the superficial femoral artery: twelve-month results from a multicenter randomized trial. J Endovasc Ther. 2015 Feb;22(1):1-10. doi: 10.1177/1526602814564385.