Clinical trial NCT01960647: FREERIDE STUDY, Freeway Paclitaxel Coated Balloon Catheter to Treat Peripheral Artery Disease
Official title: Phase III FREERIDE STUDY Freeway Randomized Angioplasty Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Peripheral Artery Disease
Lead sponsor: Eurocor GmbH
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Rate of clinically driven target lesion revascularization
timeFrame: 6 months
Secondary outcomes:
measure: Technical success
timeFrame: Baseline
measure: Clinical success
timeFrame: Baseline
measure: Procedural success
timeFrame: Baseline
measure: Ankle Brachial index improvement
timeFrame: 6, 12, 24 months
measure: Change in Rutherford classification
timeFrame: 6, 12, 24 months
measure: Walking improvement
timeFrame: 6, 12 ,24 months
measure: Rate of minor and major complications
timeFrame: 6,12, 24 months
measure: Rate of target lesion revascularization
timeFrame: 12, 24 months
measure: Late lumen loss
timeFrame: 6 months
measure: Patency rate
timeFrame: 6, 12, 24 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University
city: Cali
country: Colombia
facility: Angiografia De Occidente
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Berlin
country: Germany
facility: Ev. Krankenhaus Königin Elisabeth Herzberge
city: Berlin
country: Germany
facility: Berlin-Gefäßzentrum
city: Bremen
country: Germany
facility: Klinikum Links der Weser
city: Dresden
country: Germany
facility: Krankenhaus Dresden-Friedrichstadt
city: Leipzig
country: Germany
facility: Medical University
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Tuebingen
country: Germany
facility: Universitätsklinikum Tuebingen
city: Budapest
country: Hungary
facility: Semmelweis Universitíy
city: Abano Terme
country: Italy
facility: Policlinico Abano Terme
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
city: Mercogliano
country: Italy
facility: Casa di Cura Privata Montevergine S.p.a.
city: Torino
country: Italy
facility: San Giovanni Battista "Molinette"
city: Torino
country: Italy
facility: San Giovanni Bosco Hospital
city: San Sebastian
country: Spain
facility: Hospital Universitario de Donostia
Study officials:
affiliation: Ev. Krankenhaus Königin Elisabeth Herzberge. Berlin
name: Karl-Ludwig Schulte, Prof. PhD
role: PRINCIPAL_INVESTIGATOR
References: