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

NCT01960647 | Unknown Phase 3

• 1 other identifier: Eur-003
• Study Type: interventional
• Target: 280
• Locations: 6 countries
• Sites: 17

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.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• Rate of clinically driven target lesion revascularization

  6 months

Secondary Outcomes (10)

• 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

Study Arms (2)

Uncoated PTA balloon catheter

OTHER

Dilatation with uncoated PTA balloon catheter

Device: Percutaneous transluminal angioplasty with uncoated balloon

Freeway Paclitaxel balloon catheter

ACTIVE COMPARATOR

Dilatation with Freeway Paclitaxel (3 µg/mm2) coated balloon catheter

Device: Percutaneous transluminal angioplasty with Paclitaxel balloon

Interventions

Percutaneous transluminal angioplasty with uncoated balloon DEVICE

Uncoated PTA balloon catheter

Percutaneous transluminal angioplasty with Paclitaxel balloon DEVICE

Freeway Paclitaxel balloon catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eurocor GmbH: lead

Study Sites (17)

Medical University

Graz, Austria

RECRUITING

Angiografia De Occidente

Cali, Colombia

RECRUITING

Ev. Krankenhaus Königin Elisabeth Herzberge

Berlin, State of Berlin, 10365, Germany

RECRUITING

Herzzentrum Bad Krozingen

Bad Krozingen, Germany

RECRUITING

Berlin-Gefäßzentrum

Berlin, Germany

NOT YET RECRUITING

Klinikum Links der Weser

Bremen, Germany

RECRUITING

Krankenhaus Dresden-Friedrichstadt

Dresden, Germany

RECRUITING

Medical University

Leipzig, Germany

RECRUITING

Universitätsklinikum Münster

Münster, Germany

RECRUITING

Universitätsklinikum Tuebingen

Tübingen, Germany

RECRUITING

Semmelweis Universitíy

Budapest, Hungary

ACTIVE NOT RECRUITING

Policlinico Abano Terme

Abano Terme, Italy

RECRUITING

Maria Cecilia Hospital

Cotignola, Italy

RECRUITING

Casa di Cura Privata Montevergine S.p.a.

Mercogliano, Italy

NOT YET RECRUITING

San Giovanni Battista "Molinette"

Torino, Italy

RECRUITING

San Giovanni Bosco Hospital

Torino, Italy

RECRUITING

Hospital Universitario de Donostia

Donostia / San Sebastian, Spain

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Karl-Ludwig Schulte, Prof. PhD

  Ev. Krankenhaus Königin Elisabeth Herzberge. Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rembert Pogge von Strandmann, PhD

CONTACT

pogge@eurocor.de

Beatriz Fernandez, PhD

CONTACT

fernandez@eurocor.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 10, 2013
• Study Start: May 1, 2011
• Primary Completion: September 1, 2014
• Last Updated: October 10, 2013

Record last verified: 2013-10

Locations

ES (1); AU (1); HU (1); IT (5); DE (8); CO (1)