Peripheral Artery Disease
Conditions
Brief summary
The primary objective of this prospective, Randomized, Controlled, Multicentre, Open Study is to investigate the inhibition of restenosis by the Paclitaxel-eluting Percutaneous transluminal angioplasty (PTA) balloon Freeway versus PTA alone in the treatment of de-novo occluded, stenotic or reoccluded, restenotic superficial femoral (SFA) or popliteal arteries.
Interventions
DEVICEPercutaneous transluminal angioplasty with uncoated balloon
DEVICEPercutaneous transluminal angioplasty with Paclitaxel balloon
Sponsors
Eurocor GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant female (\> 18 years of age) with symptomatic ischemia, requiring treatment of SFA or PI segment ( 2-5 of Rutherford classification) * Single and/or multiple de novo occluded, stenotic or reoccluded, restenotic lesion(s) of \> 70% , ≤ 15 cm in total length and vessel diameter ≥ 4mm and ≤ 7mm (by visual estimation). * Patient provides a signed informed consent and complies with the follow up visits * Successful wire crossing of lesion * At least one patent (less than 50% stenosis) tibioperoneal run-off vessel
Exclusion criteria
* Gastrointestinal bleeding or coagulopathy contraindicating use of anti-platelet therapy * Known intolerance contraindications to study medications and contrast agents, non-controllable with medication. * Patient actively participating in another device or drug study * History of hemorrhagic stroke within 3 months * Previous or planned surgical or intervention procedure within 30 days of index procedure * Significant untreated inflow disease or no normal arterial segment proximal of lesion in which duplex ultrasound velocity ratios can be measured * Acute or sub-acute thrombus in target vessel * Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon) * Patients with in-stent restenosis or prior surgery of the target lesion * Patients with abdominal aortic, iliaca or popliteal aneurysm (AAA) with ≥ 4cm diameter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of clinically driven target lesion revascularization | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Clinical success | Baseline |
| Procedural success | Baseline |
| Ankle Brachial index improvement | 6, 12, 24 months |
| Change in Rutherford classification | 6, 12, 24 months |
| Technical success | Baseline |
| Rate of minor and major complications | 6,12, 24 months |
| Rate of target lesion revascularization | 12, 24 months |
| Late lumen loss | 6 months |
| Patency rate | 6, 12, 24 months |
| Walking improvement | 6, 12 ,24 months |
Countries
Austria, Colombia, Germany, Hungary, Italy, Spain
Contacts
Primary ContactRembert Pogge von Strandmann, PhD
Backup ContactBeatriz Fernandez, PhD
Outcome results
None listed