Arteriosclerosis, Atherosclerosis, Peripheral Artery Disease, Vascular Disease
Conditions
Keywords
Stenosis, Occlusions, SFA, PTA, POBA, DRB
Brief summary
A prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an uncoated balloon catheter in patients with stenosis and occlusion of the femoropopliteal arteries.
Interventions
DEVICEPasseo-18 Lux DRB
DEVICEStandard PTA (POBA)
Sponsors
Biotronik AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 50 years, 2. Informed consent signed by patient prior to randomization 3. Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the femoropopliteal arteries ≥ 30 mm and ≤ 200 mm long 4. Rutherford Class 2 - 5 in the target limb 5. Reference Vessel Diameter (RVD) 3 - 7 mm, based on visual estimation 6. Inflow free from flow-limiting lesion (\< 50% stenosis) confirmed by angiography. Patients with flow-limiting inflow lesions (\> 50% stenosis) can be included if lesion has been treated successfully before the index procedure 7. At least one non-occluded crural vessel (eg without significant stenosis) with angiographically documented run-off to the foot 8. Successful wire crossing of the lesion 9. Willingness to comply with all specified follow-up evaluations 10. Male or negative pregnancy test of women in childbearing age
Exclusion criteria
1. Co-morbid conditions limiting life expectancy ≤ 1 year 2. Patient currently participating in another clinical trial 3. Lesions which are untreatable with PTA or other interventional techniques 4. The target stenosis is located distal to a stenosis ≥ 50% that cannot be pre-treated because the drug coating could get lost during crossing the proximal lesion 5. Thrombus in the target vessel, documented by angiography 6. Target lesion is severely calcified, documented by angiography 7. Prior bypass surgery of target vessel 8. Previously implanted stent in the target lesion 9. Treatment of bifurcation required 10. Planned amputation of the target limb 11. Flow-limiting (\> 50% DS) Inflow lesion proximal to target lesion, left untreated 12. Failure to obtain \<30% residual stenosis in a pre-existing haemodynamically significant (\>50% DS) inflow lesion in the ipsilateral iliac or proximal SFA. (DEB or DES not allowed for the treatment of inflow lesion) 13. Additional hemodynamically relevant proximal and distal lesions with stenosis ≥ 50 %, except iliac arteries, are excluded. Iliac artery lesion treatments have to be successful with a residual stenosis ≤ 30 % 14. Haemorrhagic diathesis or another disorder such as gastrointestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anticoagulation therapy 15. Phenprocoumon intake 16. Impaired renal function (creatinine ≥ 2.0 - 2.5 mg/dl), according to investigator assessment 17. Known allergy to contrast media that cannot be adequately controlled with pre-medication 18. Allergy, intolerance or hypersensitivity to Paclitaxel structurally or related compounds and/or to the delivery matrix n-Butyryl tri-nhexyl citrate (BTHC)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the 6 months late lumen loss in the target lesion measured by quantitative vascular angiography (QVA). | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 6 months and 12 months change in Rutherford class | 6 and 12 months |
| Major Adverse Event rate at 6 and 12 months (procedure- or device-related death or amputation, target lesion thrombosis and clinically driven TLR) | 6 and 12 months |
| 6 months binary restenosis rate | 6 months |
| 6 months and 12 months TLR rate | 6 and 12 months |
| 6 months and 12 months change in mean ABI | 6 and 12 months |
Countries
Austria, Germany
Outcome results
None listed