FREERIDE STUDY, Freeway Paclitaxel Coated Balloon Catheter to Treat Peripheral Artery Disease
NCT ID: NCT01960647
Last Updated: 2013-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
280 participants
INTERVENTIONAL
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Uncoated PTA balloon catheter
Dilatation with uncoated PTA balloon catheter
Percutaneous transluminal angioplasty with uncoated balloon
Freeway Paclitaxel balloon catheter
Dilatation with Freeway Paclitaxel (3 µg/mm2) coated balloon catheter
Percutaneous transluminal angioplasty with Paclitaxel balloon
Interventions
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Percutaneous transluminal angioplasty with uncoated balloon
Percutaneous transluminal angioplasty with Paclitaxel balloon
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Eurocor GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Karl-Ludwig Schulte, Prof. PhD
Role: PRINCIPAL_INVESTIGATOR
Ev. Krankenhaus Königin Elisabeth Herzberge. Berlin
Locations
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Medical University
Graz, , Austria
Angiografia De Occidente
Cali, , Colombia
Ev. Krankenhaus Königin Elisabeth Herzberge
Berlin, State of Berlin, Germany
Herzzentrum Bad Krozingen
Bad Krozingen, , Germany
Berlin-Gefäßzentrum
Berlin, , Germany
Klinikum Links der Weser
Bremen, , Germany
Krankenhaus Dresden-Friedrichstadt
Dresden, , Germany
Medical University
Leipzig, , Germany
Universitätsklinikum Münster
Münster, , Germany
Universitätsklinikum Tuebingen
Tübingen, , Germany
Semmelweis Universitíy
Budapest, , Hungary
Policlinico Abano Terme
Abano Terme, , Italy
Maria Cecilia Hospital
Cotignola, , Italy
Casa di Cura Privata Montevergine S.p.a.
Mercogliano, , Italy
San Giovanni Battista "Molinette"
Torino, , Italy
San Giovanni Bosco Hospital
Torino, , Italy
Hospital Universitario de Donostia
Donostia / San Sebastian, , Spain
Countries
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Central Contacts
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Other Identifiers
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Eur-003
Identifier Type: -
Identifier Source: org_study_id