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Status unknownNCT01960647Updated Oct 10, 2013

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

A Phase 3 interventional study of Percutaneous transluminal angioplasty with uncoated balloon and Percutaneous transluminal angioplasty with Paclitaxel balloon in Peripheral Artery Disease, sponsored by Eurocor GmbH. Status unknown at 17 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-10.

Sponsored by Eurocor GmbH · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Peripheral Artery Disease
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In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's planned enrollment of 280 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Eurocor GmbH is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
280 participants (estimated)

Study arms

  • Other
    Uncoated PTA balloon catheter

    Dilatation with uncoated PTA balloon catheter

    Device: Percutaneous transluminal angioplasty with uncoated balloon

  • Active comparator
    Freeway Paclitaxel balloon catheter

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

    Device: Percutaneous transluminal angioplasty with Paclitaxel balloon

Interventions

  • DevicePercutaneous transluminal angioplasty with uncoated balloon
  • DevicePercutaneous transluminal angioplasty with Paclitaxel balloon
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What researchers measure

Primary outcomes

  1. Rate of clinically driven target lesion revascularization

    Time frame: 6 months

Secondary outcomes

  1. Technical success

    Time frame: Baseline

  2. Clinical success

    Time frame: Baseline

  3. Procedural success

    Time frame: Baseline

  4. Ankle Brachial index improvement

    Time frame: 6, 12, 24 months

  5. Change in Rutherford classification

    Time frame: 6, 12, 24 months

  6. Walking improvement

    Time frame: 6, 12 ,24 months

  7. Rate of minor and major complications

    Time frame: 6,12, 24 months

  8. Rate of target lesion revascularization

    Time frame: 12, 24 months

  9. Late lumen loss

    Time frame: 6 months

  10. Patency rate

    Time frame: 6, 12, 24 months

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Study locations

14 of 17 sites recruiting
  • Medical University
    Graz, Austria
    Recruiting
  • Angiografia De Occidente
    Cali, Colombia
    Recruiting
  • Herzzentrum Bad Krozingen
    Bad Krozingen, Germany
    Recruiting
  • Ev. Krankenhaus Königin Elisabeth Herzberge
    Berlin, 10365, 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
    Tuebingen, 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
    San Sebastian, Spain
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01960647
Lead sponsor
Eurocor GmbH
Responsible party
Sponsor
First posted
Oct 10, 2013
Start date
May 2011
Primary completion
Sep 2014 (estimated)
Last update
Oct 10, 2013

Study contacts

Rembert Pogge von Strandmann, PhD
Contact
pogge@eurocor.de
Beatriz Fernandez, PhD
Contact
fernandez@eurocor.de
Karl-Ludwig Schulte, Prof. PhD
principal investigator · Ev. Krankenhaus Königin Elisabeth Herzberge. Berlin

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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