Peripheral Artery DiseasePhase 3NCT01960647
FREERIDE STUDY, Freeway Paclitaxel Coated Balloon Catheter to Treat Peripheral Artery Disease
A Phase 3 study testing Percutaneous transluminal angioplasty with uncoated balloon and Percutaneous transluminal angioplasty with Paclitaxel balloon in people with Peripheral Artery Disease, run by Eurocor GmbH at 17 sites in 6 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Percutaneous transluminal angioplasty with uncoated balloon and Percutaneous transluminal angioplasty with Paclitaxel balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 17 sitesin 6 countries
- Study dates
- May 2011to Sep 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
17 sites in 6 countries.
Rembert Pogge von Strandmann, PhD contact
Beatriz Fernandez, PhD contact
17 sites in 6 countries
Germany8 sites, 8 recruiting
- Recruiting
Herzzentrum Bad Krozingen
Bad Krozingen
- Recruiting
Ev. Krankenhaus Königin Elisabeth Herzberge
Berlin, State of Berlin, 10365
- Not yet recruiting
Berlin-Gefäßzentrum
Berlin
- Recruiting
Klinikum Links der Weser
Bremen
- Recruiting
Krankenhaus Dresden-Friedrichstadt
Dresden
- Recruiting
Medical University
Leipzig
- Recruiting
Universitätsklinikum Münster
Münster
- Recruiting
Universitätsklinikum Tuebingen
Tübingen
Italy5 sites, 5 recruiting
- Recruiting
Policlinico Abano Terme
Abano Terme
- Recruiting
Maria Cecilia Hospital
Cotignola
- Not yet recruiting
Casa di Cura Privata Montevergine S.p.a.
Mercogliano
- Recruiting
San Giovanni Battista "Molinette"
Torino
- Recruiting
San Giovanni Bosco Hospital
Torino
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Donostia
Donostia / San Sebastian
About this study
Official title: Phase III FREERIDE STUDY Freeway Randomized Angioplasty Study
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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Percutaneous transluminal angioplasty with uncoated balloon, Percutaneous transluminal angioplasty with Paclitaxel balloon
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous transluminal angioplasty with uncoated balloonDevice
Percutaneous transluminal angioplasty with Paclitaxel balloonDevice
| Study group | Role | What they receive |
|---|---|---|
| Uncoated PTA balloon catheter | Other | Dilatation with uncoated PTA balloon catheter Receives: Device: Percutaneous transluminal angioplasty with uncoated balloon |
| Freeway Paclitaxel balloon catheter | Active comparator | Dilatation with Freeway Paclitaxel (3 µg/mm2) coated balloon catheter Receives: Device: Percutaneous transluminal angioplasty with Paclitaxel balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinically driven target lesion revascularization
Measured: 6 months
Secondary outcomes (10)
Technical success
Measured: Baseline
Clinical success
Measured: Baseline
Procedural success
Measured: Baseline
Ankle Brachial index improvement
Measured: 6, 12, 24 months
Change in Rutherford classification
Measured: 6, 12, 24 months
Walking improvement
Measured: 6, 12 ,24 months
Rate of minor and major complications
Measured: 6,12, 24 months
Rate of target lesion revascularization
Measured: 12, 24 months
Late lumen loss
Measured: 6 months
Patency rate
Measured: 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startMay 2011
- Primary completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eurocor GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl-Ludwig Schulte, Prof. PhD, Principal investigator, Ev. Krankenhaus Königin Elisabeth Herzberge. Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960647
- Sponsor's protocol ID
- Eur-003
- Status last verified
- Oct 2013
- First submitted
- 30 Sep 2013
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
PubMed 42573020
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III FREERIDE STUDY Freeway Randomized Angioplasty Study
- ClinicalTrials.gov ID
- NCT01960647
- Acronym / sponsor ID
- Eur-003
- Conditions
- Peripheral Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Eurocor GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Sep 2014 (estimated)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uncoated PTA balloon catheter | Other | Device: Percutaneous transluminal angioplasty with uncoated balloonDilatation with uncoated PTA balloon catheter |
| Freeway Paclitaxel balloon catheter | Active comparator | Device: Percutaneous transluminal angioplasty with Paclitaxel balloonDilatation with Freeway Paclitaxel (3 µg/mm2) coated balloon catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous transluminal angioplasty with uncoated balloon | Device | Uncoated PTA balloon catheter |
| Percutaneous transluminal angioplasty with Paclitaxel balloon | Device | Freeway Paclitaxel balloon catheter |
Primary outcome
Rate of clinically driven target lesion revascularization
Time frame: 6 months
10 secondary outcomes
Technical success
Time frame: Baseline
Clinical success
Time frame: Baseline
Procedural success
Time frame: Baseline
Ankle Brachial index improvement
Time frame: 6, 12, 24 months
Change in Rutherford classification
Time frame: 6, 12, 24 months
Walking improvement
Time frame: 6, 12 ,24 months
Rate of minor and major complications
Time frame: 6,12, 24 months
Rate of target lesion revascularization
Time frame: 12, 24 months
Late lumen loss
Time frame: 6 months
Patency rate
Time frame: 6, 12, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2013.
- Derived from this study: PubMed 42573020Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rembert Pogge von Strandmann, PhD contact
Beatriz Fernandez, PhD contact
Karl-Ludwig Schulte, Prof. PhD principal investigator
Ev. Krankenhaus Königin Elisabeth Herzberge. Berlin
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Percutaneous transluminal angioplasty with uncoated balloon and Percutaneous transluminal angioplasty with Paclitaxel balloon in people with Peripheral Artery Disease, run by Eurocor GmbH at 17 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Italy, Austria, Colombia, Hungary and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rembert Pogge von Strandmann, PhD (pogge@eurocor.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinically driven target lesion revascularization (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01960647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2013.