Peripheral Vascular Disease
Conditions
Keywords
Standard balloon angioplasty, POBA, Angioplasty with paclitaxel-eluting balloon, Superficial femoral artery
Brief summary
Comparison of recurrent-restenosis rates 6 months after angioplasty of in-stent restenoses or in-stent reocclusions in the superficial femoral artery (SFA) using either a standard balloon (Admiral Xtreme, Invatec) or a paclitaxel-eluting balloon (In.Pact™ Admiral, Invatec).
Interventions
DEVICEAdmiral Xtreme
For balloon angioplasty of in-stent restenosis in the superficial femoral artery
DEVICEIn.Pact Admiral
For balloon angioplasty of in-stent restenosis in the superficial femoral artery
Sponsors
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 21 years old. 2. Patient must sign informed consent form. 3. Patient must agree to participate in the study and comply with follow-up requirements. 4. Clinically, all patients must be in Rutherford category 2 to 4. Angiographic Inclusion Criteria: 5. Planned angioplasty of in-stent restenoses (degree of stenosis 70-100%) within the SFA. The target lesion must not extend beyond the stent margins. In cases of two or more stenotic regions within the stented segment, these are considered separate lesions if there is a nonstenotic or only mildly stenotic (\< 30%) segment of at least 2 cm in length between them. Otherwise, they are considered a single lesion. In case of separate lesions, only the proximal lesion will be taken as the target lesion! 6. The length of the in-stent lesion should be at least 1 cm and maximally 20 cm (measurement by radiopaque ruler). 7. The degree of target lesion stenosis must be determined by pre-interventional duplex ultrasound. 8. The target lesion region starts at the origin of the SFA and ends distally at the femoropopliteal crossover (crossing by SFA of medial rim of femur in the PA projection). 9. Patency (\< 50% stenosis) of popliteal artery and at least 1 infragenicular artery.
Exclusion criteria
General: 1. Patient is currently participating in another clinical trial. 2. Pregnancy or pregnancy planned during study duration. 3. Life expectancy less than 1 year. 4. Co-morbidities preventing study participation. 5. Severe coagulation disorders. 6. Current treatment with anticoagulants other than aspirin, ticlopidine, clopidogrel or prasugrel. 7. Active gastric ulcer or gastrointestinal bleeding. 8. Thrombotic occlusion of the target vessel within previous 4 weeks. 9. Treatment of target lesion with laser or atherectomy devices. 10. Dialysis dependency. 11. Manifest hyperthyreosis. 12. Known allergy against contrast agent that cannot be adequately controlled by usual premedication. 13. Known heparin intolerance. 14. Known paclitaxel intolerance. Angiographic: 15. Target lesion extends into the popliteal artery. 16. Symptomatic untreated inflow lesion \> 50% in ipsilateral iliac arteries. Pretreatment of iliac stenoses is possible. 17. SFA lesions \> 50% stenosis proximal and/or distal to the target lesion that require treatment. 18. Target lesion extends beyond the stent margins.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duplex-ultrasound determined recurrent restenosis in the superficial femoral artery (SFA) | 6 month | Binary restenosis rate by Duplex-ultrasound \>= 50% measured as proximal peak velocity ratio PVR\[prox\] \>= 2.4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically driven target lesion revascularization (TLR) at 6 and 12 month | 6 and 12 month | — |
| Recurrent stenosis >= 70% within the stent at 6 and 12 month | 6 and 12 month | Recurrent restenosis \>= 70% measured as proximal peak velocity ratio PVR\[prox\] \>= 3.4 |
| Clinical and hemodynamic parameters | at 1, 6 and 12 month | Walking distance, ABI, Rutherford category |
| Recurrent restenosis within the stent at 12 month | 12 month | Recurrent restenosis \>= 50% measured as proximal peak velocity ratio PVR\[prox\] \>= 2.4 |
| Major adverse vascular events (MAVE) | 12 month | — |
| Death | 12 month | — |
| Impact of bail-out stent-in-stent placement on 6-and 12-month end points | 6 and 12 month | — |
| Primary angiographic success rate | 12 month | Angiographic sucess: \<50% residual stenosis |
Countries
Germany
Outcome results
None listed