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

Phase III FREERIDE STUDY Freeway Randomized Angioplasty Study

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: Percutaneous transluminal angioplasty with uncoated balloon; Device: Percutaneous transluminal angioplasty with Paclitaxel balloon

• Study Type: Interventional
• Enrollment (Anticipated): 280
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Recruiting
    • Medical University
• Colombia
  • Cali, Colombia
    • Recruiting
    • Angiografia de Occidente
• Germany
  • Bad Krozingen, Germany
    • Recruiting
    • Herzzentrum Bad Krozingen
  • Berlin, Germany, 10365
    • Recruiting
    • Ev. Krankenhaus Königin Elisabeth Herzberge
  • Berlin, Germany
    • Not yet recruiting
    • Berlin-Gefäßzentrum
  • Bremen, Germany
    • Recruiting
    • Klinikum Links der Weser
  • Dresden, Germany
    • Recruiting
    • Krankenhaus Dresden-Friedrichstadt
  • Leipzig, Germany
    • Recruiting
    • Medical University
  • Münster, Germany
    • Recruiting
    • Universitatsklinikum Munster
  • Tuebingen, Germany
    • Recruiting
    • Universitätsklinikum Tuebingen
• Hungary
  • Budapest, Hungary
    • Active, not recruiting
    • Semmelweis Universitíy
• Italy
  • Abano Terme, Italy
    • Recruiting
    • Policlinico Abano Terme
  • Cotignola, Italy
    • Recruiting
    • Maria Cecilia Hospital
  • Mercogliano, Italy
    • Not yet recruiting
    • Casa di Cura Privata Montevergine S.p.A.
  • Torino, Italy
    • Recruiting
    • San Giovanni Battista "Molinette"
  • Torino, Italy
    • Recruiting
    • San Giovanni Bosco Hospital
• Spain
  • San Sebastian, Spain
    • Recruiting
    • Hospital Universitario DE Donostia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of clinically driven target lesion revascularization	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Late lumen loss	6 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
Walking improvement	6, 12 ,24 months
Rate of minor and major complications	6,12, 24 months
Rate of target lesion revascularization	12, 24 months
Patency rate	6, 12, 24 months

Collaborators and Investigators

• Sponsor: Eurocor GmbH
• Investigators: Principal Investigator: Karl-Ludwig Schulte, Prof. PhD, Ev. Krankenhaus Königin Elisabeth Herzberge. Berlin

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ANTICIPATED): September 1, 2014

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (ESTIMATE): October 10, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 10, 2013
• Last Update Submitted That Met QC Criteria: October 9, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: Eur-003