European Study of POBA Versus Cotavance(R) Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia (EURO CANAL)

European Study of POBA Versus Cotavance Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01260870

Enrollment

Registered

2010-12-15

Start date

2011-08-15

Completion date

2013-07-15

Last updated

2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infrapopliteal Lesions, PAD

Brief 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.

Interventions

DEVICECotavance Paclitaxel Coated Balloon

DEVICEStandard balloon angioplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

\- Subjects with CLI

Exclusion criteria

* Participation in another research trial * Medical conditions the study doctor will assess

Design outcomes

Primary

Measure	Time frame
Evaluate procedural safety	30 days

Secondary

Measure	Time frame
Identify and characterize therapeutic and functional endpoint assessments	5 years

Countries

Austria, Belgium, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026