PADPhase 2NCT01260870
European Study of POBA Versus Cotavance(R) Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia (EURO CANAL)
A Phase 2 study testing Cotavance Paclitaxel Coated Balloon and Standard balloon angioplasty in people with PAD and Infrapopliteal Lesions, run by Bayer at 6 sites in 4 countries.
Trial summary
To evaluate the procedural safety and to identify and characterize therapeutic and functional endpoint assessments in subjects with documented critical limb ischemia who received treatment with the Cotavance Paclitaxel-Coated Balloon vs. those who received POBA only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PAD, Infrapopliteal Lesions
- What is being tested?
- Cotavance Paclitaxel Coated Balloon and Standard balloon angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 15 Aug 2011to 15 Jul 2013
- Phase
- Phase 2
- 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
- Subjects with CLI
Who cannot join
- Participation in another research trial
- Medical conditions the study doctor will assess
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
About this study
Official title: European Study of POBA Versus Cotavance Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia
To evaluate the procedural safety and to identify and characterize therapeutic and functional endpoint assessments in subjects with documented critical limb ischemia who received treatment with the Cotavance Paclitaxel-Coated Balloon vs. those who received POBA only.
- Conditions
- PAD, Infrapopliteal Lesions
- Being tested
- Cotavance Paclitaxel Coated Balloon, Standard balloon angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cotavance Paclitaxel Coated BalloonDevice
Also called DEB
Standard balloon angioplastyDevice
Also called POBA
| Study group | Role | What they receive |
|---|---|---|
| Cotavance | Experimental | Not described Receives: Device: Cotavance Paclitaxel Coated Balloon |
| Standard balloon angioplasty | Active comparator | POBA Receives: Device: Standard balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate procedural safety
Measured: 30 days
Secondary outcomes (1)
Identify and characterize therapeutic and functional endpoint assessments
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study start15 Aug 2011
- Primary completion15 Jul 2013
- Study completion15 Jul 2013
Why it stopped: Bayer terminated the program and sold the IP to Medronic
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 PADStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260870
- Sponsor's protocol ID
- EURO CANAL
- Status last verified
- Jan 2024
- First submitted
- 13 Dec 2010
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Study of POBA Versus Cotavance Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT01260870
- Acronym / sponsor ID
- EURO CANAL
- Conditions
- PAD, Infrapopliteal Lesions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Bayer terminated the program and sold the IP to Medronic
- Enrolment
- 44 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2011 (actual)
- Primary completion
- 15 Jul 2013 (actual)
- Study completion
- 15 Jul 2013 (actual)
- First posted
- 15 Dec 2010 (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.
To evaluate the procedural safety and to identify and characterize therapeutic and functional endpoint assessments in subjects with documented critical limb ischemia who received treatment with the Cotavance Paclitaxel-Coated Balloon vs. those who received POBA only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cotavance | Experimental | Device: Cotavance Paclitaxel Coated Balloon |
| Standard balloon angioplasty | Active comparator | Device: Standard balloon angioplastyPOBA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with CLI
Key exclusion criteria (2 listed)
- Participation in another research trial
- Medical conditions the study doctor will assess
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 |
|---|---|---|
| Cotavance Paclitaxel Coated BalloonAlso: DEB | Device | Cotavance |
| Standard balloon angioplastyAlso: POBA | Device | Standard balloon angioplasty |
Primary outcome
Evaluate procedural safety
Time frame: 30 days
1 secondary outcome
Identify and characterize therapeutic and functional endpoint assessments
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Bayer terminated the program and sold the IP to Medronic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- 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.
Bayer Study Director study director
Bayer
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cotavance Paclitaxel Coated Balloon and Standard balloon angioplasty in people with PAD and Infrapopliteal Lesions, run by Bayer at 6 sites in 4 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Switzerland, Austria, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Bayer terminated the program and sold the IP to Medronic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate procedural safety (time frame: 30 days). 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 NCT01260870, 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 30 Jan 2024.