Suspended
Cotavance™ Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Treatment of In-stent Restenosis in SFA and Popliteal Arteries COPA CABANA Study
What is being tested
balloon angiolplasty - drug coated balloon (Cotavance, Medrad Inc.)
+ drug coated balloon inflation (Cotavance, Medrad Inc.)
+ uncoated balloon (e.g. Admiral, Medtronic)
Device
Who is being recruted
Arterial Occlusive Diseases+4
+ Arteriosclerosis
+ Cardiovascular Diseases
Over 18 Years
+33 Eligibility Criteria
How is the trial designed
Prevention Study
Placebo-ControlledPhase 2 & 3
Interventional
Study Start: January 2012
Summary
Principal SponsorProf. Dr. med. Gunnar Tepe
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2012
Actual date on which the first participant was enrolled.In stent restenosis in peripheral artery disease (superficial and popliteal artery) either treated with uncoated or paclitaxel coated balloons.
Official TitleCotavance™ Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Treatment of In-stent Restenosis in SFA and Popliteal Arteries COPA CABANA Study
Principal SponsorProf. Dr. med. Gunnar Tepe
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
112 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesVascular DiseasesPeripheral Vascular DiseasesAtherosclerosisPeripheral Arterial Disease
Criteria
10 inclusion criteria required to participate
In-stent restenosis or re-occlusion at the target lesion due to an interventional treatment > 3 months prior to enrollment.
Has evidence of ≥ 70% stenosis or occlusion in the SFA and/or popliteal confirmed by angiography that is 3-27 cm long.
Reference vessel diameter of 3 to 7 mm (reference vessel diameter = normal vessel diameter 1 cm proximal of the index lesion)
Patients (men and women) with PAD disease category 2 to 5 according to Rutherford classification.
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23 exclusion criteria prevent from participating
Patients with more than two lesions in the target vessel requiring treatment (if the distance between two lesions is less than 2 cm, the lesions should be counted as one lesion). The second lesion should also be treated with either coated or uncoated balloons (according to the randomization)
Guidewire cannot cross lesion and/or an intentional subintimal approach in the stented lesion is required.
Patients with stent fractures grade 2-4.
Inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to treatment of the study lesion.
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
Active Comparatortreatment with drug eltuing balloon
Group II
Placebotreatment with uncoated balloon
Group III
Active Comparatorif treatment fails 30 days or later
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 6 locations
Recruiting
Recruiting
Tepe
Rosenheim, GermanyRecruiting
Uniklinik Tübingen
Tübingen, GermanyRecruiting
Jüdisches Krankenhaus
Berlin, GermanySuspended6 Study Centers