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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Eurocor GmbH
Sponsor:
Information provided by (Responsible Party):
Eurocor GmbH
ClinicalTrials.gov Identifier:
NCT01960647
First received: September 30, 2013
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Peripheral Artery Disease
Device: Percutaneous transluminal angioplasty with uncoated balloon
Device: Percutaneous transluminal angioplasty with Paclitaxel balloon
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III FREERIDE STUDY Freeway Randomized Angioplasty Study

Resource links provided by NLM:


Further study details as provided by Eurocor GmbH:

Primary Outcome Measures:
  • Rate of clinically driven target lesion revascularization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Technical success [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
  • Clinical success [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
  • Procedural success [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
  • Ankle Brachial index improvement [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Change in Rutherford classification [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Walking improvement [ Time Frame: 6, 12 ,24 months ] [ Designated as safety issue: No ]
  • Rate of minor and major complications [ Time Frame: 6,12, 24 months ] [ Designated as safety issue: Yes ]
  • Rate of target lesion revascularization [ Time Frame: 12, 24 months ] [ Designated as safety issue: Yes ]
  • Late lumen loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patency rate [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: May 2011
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960647

Contacts
Contact: Rembert Pogge von Strandmann, PhD pogge@eurocor.de
Contact: Beatriz Fernandez, PhD fernandez@eurocor.de

Locations
Austria
Medical University Recruiting
Graz, Austria
Colombia
Angiografia De Occidente Recruiting
Cali, Colombia
Germany
Herzzentrum Bad Krozingen Recruiting
Bad Krozingen, Germany
Berlin-Gefäßzentrum Not yet recruiting
Berlin, Germany
Ev. Krankenhaus Königin Elisabeth Herzberge Recruiting
Berlin, Germany, 10365
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
Hungary
Semmelweis Universitíy Active, not recruiting
Budapest, Hungary
Italy
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 Bosco Hospital Recruiting
Torino, Italy
San Giovanni Battista "Molinette" Recruiting
Torino, Italy
Spain
Hospital Universitario de Donostia Recruiting
San Sebastian, Spain
Sponsors and Collaborators
Eurocor GmbH
Investigators
Principal Investigator: Karl-Ludwig Schulte, Prof. PhD Ev. Krankenhaus Königin Elisabeth Herzberge. Berlin
  More Information

No publications provided

Responsible Party: Eurocor GmbH
ClinicalTrials.gov Identifier: NCT01960647     History of Changes
Other Study ID Numbers: Eur-003
Study First Received: September 30, 2013
Last Updated: October 9, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014