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

Peripheral Artery Disease Clinical Trial

Official title:

Phase III FREERIDE STUDY Freeway Randomized Angioplasty Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01960647
• Other study ID #: Eur-003
• Status: Recruiting
• Phase: Phase 3
• First received: September 30, 2013
• Last updated: October 9, 2013
• Start date: May 2011

Study information

• Verified date: October 2013
• Source: Eurocor GmbH
• Contact: Rembert Pogge von Strandmann, PhD
• Email: pogge[@]eurocor.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Percutaneous transluminal angioplasty with uncoated balloon

• Percutaneous transluminal angioplasty with Paclitaxel balloon

Locations

Country	Name	City	State
Austria	Medical University	Graz
Colombia	Angiografia De Occidente	Cali
Germany	Herzzentrum Bad Krozingen	Bad Krozingen
Germany	Berlin-Gefäßzentrum	Berlin
Germany	Ev. Krankenhaus Königin Elisabeth Herzberge	Berlin
Germany	Klinikum Links der Weser	Bremen
Germany	Krankenhaus Dresden-Friedrichstadt	Dresden
Germany	Medical University	Leipzig
Germany	Universitätsklinikum Münster	Münster
Germany	Universitätsklinikum Tuebingen	Tuebingen
Hungary	Semmelweis Universitíy	Budapest
Italy	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
Spain	Hospital Universitario de Donostia	San Sebastian

Sponsors (1)

Lead Sponsor	Collaborator
Eurocor GmbH

Countries where clinical trial is conducted

Austria,  Colombia,  Germany,  Hungary,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinically driven target lesion revascularization		6 months	Yes
Secondary	Technical success		Baseline	Yes
Secondary	Clinical success		Baseline	Yes
Secondary	Procedural success		Baseline	Yes
Secondary	Ankle Brachial index improvement		6, 12, 24 months	No
Secondary	Change in Rutherford classification		6, 12, 24 months	No
Secondary	Walking improvement		6, 12 ,24 months	No
Secondary	Rate of minor and major complications		6,12, 24 months	Yes
Secondary	Rate of target lesion revascularization		12, 24 months	Yes
Secondary	Late lumen loss		6 months	No
Secondary	Patency rate		6, 12, 24 months	No