GORE VIABAHN® Versus Plain Old Balloon Angioplasty (POBA) for Superficial Femoral Artery (SFA) In-Stent Restenosis

NCT01108861 | Completed Phase 4

• 1 other identifier: FMRP-100107
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 6

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.

Conditions

Peripheral Vascular Disease

Keywords

Peripheral Vascular Disease; In-stent restenosis; Endoprosthesis; Plain old balloon angioplasty

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• Proportion of subjects who experience serious device-related adverse events within 30 days post-procedure

  30 days

Secondary Outcomes (9)

• Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.

  during procedure

• Hemodynamic primary patency rate at 1, 6, 12, 24-month follow-up.

  1, 6, 12, 24-month follow-up

• Angiographic primary patency at 12 months

  1 year

• Primary assisted patency rate at 1, 6, 12, 24-month follow-up.

  1, 6, 12, 24-month follow-up

• Secondary patency rate at 1, 6, 12, 24-month follow-up

  1, 6, 12, 24-month follow-up

Study Arms (2)

Endoprosthesis

EXPERIMENTAL

GORE VIABAHN® Endoprosthesis

Device: GORE VIABAHN® Endoprosthesis

Plain old balloon angioplasty

ACTIVE COMPARATOR

Plain old balloon angioplasty

Device: Plain old balloon angioplasty

Interventions

GORE VIABAHN® Endoprosthesis DEVICE

GORE VIABAHN® Endoprosthesis

Endoprosthesis

Plain old balloon angioplasty DEVICE

Plain old balloon angioplasty

Plain old balloon angioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (6)

Imelda Hospital

Bonheiden, 2820, Belgium

Location

AZ Sint-Blasius

Dendermonde, 9200, Belgium

Location

Universitair ziekenhuis antwerpen

Edegem, 2650, Belgium

Location

Zuid Oost Limburg

Genk, 3600, Belgium

Location

Herz-zentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Herzzentrum

Leipzig, 04289, Germany

Location

Related Publications (1)

• 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.

  PMID: 25775672 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marc Bosiers, MD

  AZ Sint Blasius

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 22, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2014
• Last Updated: September 3, 2014

Record last verified: 2014-09

Locations

BE (4); DE (2)