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

Phase 3

• Conditions: Peripheral Artery Disease

• Registration Number: NCT01960647
• Lead Sponsor: Eurocor GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2013-09-30
• Status Verified: 2013-10
• Study First Submitted QC: 2013-10-09
• Last Update Submitted: 2013-10-09
• Study First Posted: 2013-10-10
• Last Update Posted: 2013-10-10
• Primary Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Walking improvement	6, 12 ,24 months
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

Trial Locations

Locations (16)

Medical University; 🇩🇪 Leipzig, Germany

Angiografia De Occidente; 🇨🇴 Cali, Colombia

Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Ev. Krankenhaus Königin Elisabeth Herzberge; 🇩🇪 Berlin, Germany

Berlin-Gefäßzentrum; 🇩🇪 Berlin, Germany

Klinikum Links der Weser; 🇩🇪 Bremen, Germany

Krankenhaus Dresden-Friedrichstadt; 🇩🇪 Dresden, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Germany

Universitätsklinikum Tuebingen; 🇩🇪 Tuebingen, Germany

Semmelweis Universitíy; 🇭🇺 Budapest, Hungary

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