FREERIDE STUDY, Freeway Paclitaxel Coated Balloon Catheter to Treat Peripheral Artery Disease

Phase 3

Interventions: Device: Percutaneous transluminal angioplasty with uncoated balloon
Device: Percutaneous transluminal angioplasty with Paclitaxel balloon

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Uncoated PTA balloon catheter	Percutaneous transluminal angioplasty with uncoated balloon	Dilatation with uncoated PTA balloon catheter
Freeway Paclitaxel balloon catheter	Percutaneous transluminal angioplasty with Paclitaxel balloon	Dilatation with Freeway Paclitaxel (3 µg/mm2) coated balloon catheter

Primary Outcome Measures

Name	Time	Method
Rate of clinically driven target lesion revascularization	6 months

Secondary Outcome Measures

Name	Time	Method
Technical success	Baseline
Clinical success	Baseline
Procedural success	Baseline
Ankle Brachial index improvement	6, 12, 24 months
Change in Rutherford classification	6, 12, 24 months
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

Locations (16): Angiografia De Occidente
🇨🇴
Cali, Colombia
Ev. Krankenhaus Königin Elisabeth Herzberge
🇩🇪
Berlin, Germany
Policlinico Abano Terme
🇮🇹
Abano Terme, Italy
Maria Cecilia Hospital
🇮🇹
Cotignola, Italy
Herzzentrum Bad Krozingen
🇩🇪
Bad Krozingen, Germany
Universitätsklinikum Tuebingen
🇩🇪
Tuebingen, Germany
Klinikum Links der Weser
🇩🇪
Bremen, Germany
Universitätsklinikum Münster
🇩🇪
Münster, Germany
San Giovanni Bosco Hospital
🇮🇹
Torino, Italy
Berlin-Gefäßzentrum
🇩🇪
Berlin, Germany
Medical University
🇩🇪
Leipzig, Germany
Semmelweis Universitíy
🇭🇺
Budapest, Hungary
Casa di Cura Privata Montevergine S.p.a.
🇮🇹
Mercogliano, Italy
Hospital Universitario de Donostia
🇪🇸
San Sebastian, Spain
Krankenhaus Dresden-Friedrichstadt
🇩🇪
Dresden, Germany
San Giovanni Battista "Molinette"
🇮🇹
Torino, Italy