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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01960647
Recruitment Status : Unknown
Verified October 2013 by Eurocor GmbH.
Recruitment status was:  Recruiting
First Posted : October 10, 2013
Last Update Posted : October 10, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Device: Percutaneous transluminal angioplasty with uncoated balloon Device: Percutaneous transluminal angioplasty with Paclitaxel balloon Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III FREERIDE STUDY Freeway Randomized Angioplasty Study
Study Start Date : May 2011
Estimated Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Uncoated PTA balloon catheter
Dilatation with uncoated PTA balloon catheter
Device: Percutaneous transluminal angioplasty with uncoated balloon
Active Comparator: Freeway Paclitaxel balloon catheter
Dilatation with Freeway Paclitaxel (3 µg/mm2) coated balloon catheter
Device: Percutaneous transluminal angioplasty with Paclitaxel balloon

Primary Outcome Measures :
  1. Rate of clinically driven target lesion revascularization [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Technical success [ Time Frame: Baseline ]
  2. Clinical success [ Time Frame: Baseline ]
  3. Procedural success [ Time Frame: Baseline ]
  4. Ankle Brachial index improvement [ Time Frame: 6, 12, 24 months ]
  5. Change in Rutherford classification [ Time Frame: 6, 12, 24 months ]
  6. Walking improvement [ Time Frame: 6, 12 ,24 months ]
  7. Rate of minor and major complications [ Time Frame: 6,12, 24 months ]
  8. Rate of target lesion revascularization [ Time Frame: 12, 24 months ]
  9. Late lumen loss [ Time Frame: 6 months ]
  10. Patency rate [ Time Frame: 6, 12, 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01960647

Contact: Rembert Pogge von Strandmann, PhD
Contact: Beatriz Fernandez, PhD

Medical University Recruiting
Graz, Austria
Angiografia De Occidente Recruiting
Cali, Colombia
Herzzentrum Bad Krozingen Recruiting
Bad Krozingen, Germany
Ev. Krankenhaus Königin Elisabeth Herzberge Recruiting
Berlin, Germany, 10365
Berlin-Gefäßzentrum Not yet recruiting
Berlin, Germany
Klinikum Links der Weser Recruiting
Bremen, Germany
Krankenhaus Dresden-Friedrichstadt Recruiting
Dresden, Germany
Medical University Recruiting
Leipzig, Germany
Universitätsklinikum Münster Recruiting
Münster, Germany
Universitätsklinikum Tuebingen Recruiting
Tuebingen, Germany
Semmelweis Universitíy Active, not recruiting
Budapest, Hungary
Policlinico Abano Terme Recruiting
Abano Terme, Italy
Maria Cecilia Hospital Recruiting
Cotignola, Italy
Casa di Cura Privata Montevergine S.p.a. Not yet recruiting
Mercogliano, Italy
San Giovanni Battista "Molinette" Recruiting
Torino, Italy
San Giovanni Bosco Hospital Recruiting
Torino, Italy
Hospital Universitario de Donostia Recruiting
San Sebastian, Spain
Sponsors and Collaborators
Eurocor GmbH
Principal Investigator: Karl-Ludwig Schulte, Prof. PhD Ev. Krankenhaus Königin Elisabeth Herzberge. Berlin

Responsible Party: Eurocor GmbH Identifier: NCT01960647     History of Changes
Other Study ID Numbers: Eur-003
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: October 10, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action