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

Eurocor

Status and phase: Unknown; Phase 3

Conditions: Peripheral Artery Disease

Treatments: Device: Percutaneous transluminal angioplasty with uncoated balloon; Device: Percutaneous transluminal angioplasty with Paclitaxel balloon

Study type: Interventional

Funder types: Industry

Identifiers

NCT01960647

Eur-003

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

Uncoated PTA balloon catheter

Other group

Description:

Dilatation with uncoated PTA balloon catheter

Treatment:

Device: Percutaneous transluminal angioplasty with uncoated balloon

Freeway Paclitaxel balloon catheter

Active Comparator group

Description:

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

Treatment:

Device: Percutaneous transluminal angioplasty with Paclitaxel balloon