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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
GORE VIABAHN® Endoprosthesis
Plain old balloon angioplasty
Imelda Hospital
Bonheiden, Belgium
AZ Sint-Blasius
Dendermonde, Belgium
Universitair ziekenhuis antwerpen
Edegem, Belgium
Zuid Oost Limburg
Genk, Belgium
Herz-zentrum Bad Krozingen
Bad Krozingen, Germany
Herzzentrum
Leipzig, Germany
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.
Time frame: 1 year
Proportion of subjects who experience serious device-related adverse events within 30 days post-procedure
Time frame: 30 days
Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.
Time frame: during procedure
Hemodynamic primary patency rate at 1, 6, 12, 24-month follow-up.
Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.5) and without prior TLR are defined as being primary patent at the given follow-up.
Time frame: 1, 6, 12, 24-month follow-up
Angiographic primary patency at 12 months
Angiographic primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on no Quantitative Angiographic evidence of stenosis \> 50%
Time frame: 1 year
Primary assisted patency rate at 1, 6, 12, 24-month follow-up.
Primary assisted patency rate at 1, 6, 12, 24-month follow-up. Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure.
Time frame: 1, 6, 12, 24-month follow-up
Secondary patency rate at 1, 6, 12, 24-month follow-up
Secondary patency rate at 1, 6, 12, 24-month follow-up. Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion.
Time frame: 1, 6, 12, 24-month follow-up
Target lesion revascularization (TLR)
Target lesion revascularization (TLR) is defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the device/PTA edge
Time frame: entire follow-up
Clinical success at follow-up
Clinical success at follow-up is defined as an improvement of Rutherford classification at 1 day and 1, 6, 12, 24-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
Time frame: at 1 day and 1, 6, 12, 24-month follow-up
Serious adverse events
Serious adverse events as defined as any clinical event that is fatal, life-threatening, results in persistent or significant disability/incapacity, requires in-patient hospitalization or unduly prolonged hospitalization, necessitates an intervention to prevent a permanent impairment of a body function or permanent damage to a body structure, is a congenital abnormality/birth defect, a fetal distress or fetal death, results in malignancy
Time frame: during entire follow-up
Stent fracture rate at 12 months
Stent fracture rate at 12 months, determined by using the following classifications on X-ray: 1. Class 0 : no strut factures 2. Class I : single tine fracture 3. Class II : multiple tine factures 4. Class III : Stent fracture(s) with preserved alignment of the components 5. Class IV : Stent fracture(s) with mal-alignment of the components 6. Class V : Stent fracture(s) in a trans-axial spiral configuration
Time frame: 1 year
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