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

E

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)

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

Trial contacts and locations

17

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Central trial contact

Beatriz Fernandez, PhD; Rembert Pogge von Strandmann, PhD

Data sourced from clinicaltrials.gov

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