AzTrials
AzTrials

CatherizationPhase 2/3NCT01594684

Cotavance™ Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Treatment of In-stent Restenosis in SFA and Popliteal Arteries

A Phase 2/3 study testing balloon angiolplasty - drug coated balloon (Cotavance, Medrad Inc.), drug coated balloon inflation (Cotavance, Medrad Inc.) and uncoated balloon (e.g. Admiral, Medtronic) in people with Catherization, run by Prof. Dr. med. Gunnar Tepe at 6 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

In stent restenosis in peripheral artery disease (superficial and popliteal artery) either treated with uncoated or paclitaxel coated balloons. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Catherization
What is being tested?
balloon angiolplasty - drug coated balloon (Cotavance, Medrad Inc.), drug coated balloon inflation (Cotavance, Medrad Inc.) and uncoated balloon (e.g. Admiral, Medtronic)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
6 sitesGermany
Study dates
Jan 2012to Jun 2016
Phase
Phase 2/3
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

  • 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.
  • Patient is eligible for an operative vascular intervention in case of complications during the procedure.
  • Female patients of child bearing potential must have a negative pregnancy test 7 days at theprior to the time of intervention.
Show all 10Show fewer
  • Fully informed and signed consent must be obtained from each patient.
  • Patients must be willing and able to continue study participation following study procedure in order to ensure completion of all procedures and observations required by protocol.
  • Patient has evidence of at least one run off vessel that does not also require treatment for significant (≥ 50% stenosis or occlusion) stenosis during the index procedure to the ankle/foot of the limb to be treated. Treatment of infrapopliteal lesions must be staged at least 30 days before or after the index procedure.
  • If restnosis occurs in both arms 30 days or later (re-re-sternosis)- treament with two drug eluting balloons at the same location (double dose)

Who cannot join

  • 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.
  • Acute thrombosis of the study lesion requiring lysis or thrombectomy prior to the treatment of the study lesion.
  • Acutely occurring symptoms with a lyses or an operation as a therapeutic option within the last 6 weeks within the study limb.
Show all 23Show fewer
  • Potential loss of leg due to critical or acute ischemia.
  • No patent distal run-off vessel.
  • Aneurysm in the blood vessel intended for intervention in this study.
  • Blood platelet count < 100.000/mm3 or >700.000/mm3, leukocyte count < 3.000/mm3.
  • Contra-indication to anticoagulation, or any anti-platelet agent (e.g. aspirin, heparin, clopidogrel, ticlopidine, abciximab), or paclitaxel.
  • Known intolerance or contra-indication (e.g. severe hepatic (with ALAT and/or ASAT > 3 times the normal reference range) or renal (creatinine > 1.1 mg/dl in women and >1.5 mg/dl in men) to contrast agents which cannot be adequately pre-treated, e.g. with adequate hydration.
  • Severe illnesses such as cancer, liver or renal diseases, myocardial insufficiency leading to protocol deviations and/or a reduced life expectancy of less than 2 years.
  • Manifest hyperthyreosis.
  • Latent hyperthyreosis without adequate therapy, e.g., previous blocking with Natriumperchlorat (Irenat®).
  • Significant gastrointestinal hemorrhage within the previous 6 months prior to study participation.
  • History of hemorrhagic diathesis or coagulopathy or rejection of blood transfusions.
  • Medical reason against double anti-platelet therapy in anti-coagulated patient, e.g., receiving coumadine.
  • Any severe medical condition that might interfere with the interpretation of the data or result in an unacceptable risk for the patient's participation in the study, according to the judgment of the clinical investigator.
  • Female patient who is pregnant or lactating.
  • Patient under 18 years of age.
  • Participation in another clinical study up to 30 days prior to study entry.
  • Previous participation in the same trialstudy (only one leg can be treated within the study).

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites, 6 recruiting

  • Herzzentrum Bad Krozingen

    Bad Krozingen, Baden-Wurttemberg, 73000

    Thomas Zeller, MD, 076334022431, thomas.zeller@herzzentrum.de

    Thomas Zeller, MD

    Recruiting

  • Jüdisches Krankenhaus

    Berlin, DE, 0001

    Stefan Duda, MD, stefan.duda@t-online.de

    Stefan Duda, MD

    Recruiting

  • Klinikum Neukölln

    Berlin, DE, 0001

    Thomas Albrecht, MD, 030-2983366, thomas.albrecht@t-online.de

    Thomas Albrecht, MD

    Recruiting

  • Klinikum Neumünster

    Neumünster, Schleswig-Holstein, 24534

    Thomas Jahnke, MD, 04321 405-4910, thomas.jahnke@fek.de

    Thomas Jahnke, MD

    Recruiting

  • Tepe

    Rosenheim, Baden-Wurttemberg, 83022

    Gunnar Tepe, MD, 80313653551, gunnar.tepe@ro-med.de

    Gunnar Tepe, MD

    Recruiting

  • Uniklinik Tübingen

    Tübingen, Baden-Wurttemberg, 73022

    Klaus Brechtel, MD, 070712983371, klaus.brechtel@uni-tuebingen.de

    Recruiting

Other trials in Germany

About this study

Official title: Cotavance™ Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Treatment of In-stent Restenosis in SFA and Popliteal Arteries COPA CABANA Study

In stent restenosis in peripheral artery disease (superficial and popliteal artery) either treated with uncoated or paclitaxel coated balloons.

Conditions
Catherization
Being tested
balloon angiolplasty - drug coated balloon (Cotavance, Medrad Inc.), drug coated balloon inflation (Cotavance, Medrad Inc.), uncoated balloon (e.g. Admiral, Medtronic), balloon inflation, drug coated balloon (Cotavance, Medrad Inc.)
Keywords
restenosis, stent, drug eltuing balloon, peripheral arterial disease
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.

  • balloon angiolplasty - drug coated balloon (Cotavance, Medrad Inc.)Device

    balloon inflation

  • drug coated balloon inflation (Cotavance, Medrad Inc.)Device

    Balloon inflation

  • uncoated balloon (e.g. Admiral, Medtronic)Device

    balloon inflation

  • balloon inflation, drug coated balloon (Cotavance, Medrad Inc.)Device

    ballon inflation

Study groups in NCT01594684
Study groupRoleWhat they receive
drug eluting balloonActive comparatortreatment with drug eltuing balloon
Receives: Device: balloon angiolplasty - drug coated balloon (Cotavance, Medrad Inc.); Device: drug coated balloon inflation (Cotavance, Medrad Inc.)
uncoated balloonPlacebo comparatortreatment with uncoated balloon
Receives: Device: uncoated balloon (e.g. Admiral, Medtronic)
double drug eluting balloonActive comparatorif treatment fails 30 days or later
Receives: Device: balloon inflation, drug coated balloon (Cotavance, Medrad Inc.)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Late Lumen Loss (LLL)

    • Late lumen loss (difference between the angiographic minimum lumen diameter (MLD) immediately and at 6 months post index procedure) evaluated by quantitative angiography. Analysis will be performed by an independent Angiographic Core Laboratory

    Measured: 6 +/-2 months

Secondary outcomes (12)

  1. • Procedural success

    • Procedural success defined as ≤ 30% residual stenosis following the procedure at the target lesion (after prolonged dilation and stenting, if necessary)

    Measured: after intervention

  2. Target lesion revascularization (TLR)

    • Clinically-driven target lesion revascularization (TLR) at 6, 12 and 24 months. Target lesion revascularization is defined as any reintervention or artery bypass graft surgery involving the target lesion.

    Measured: 6, 12 and 24 months

  3. Target vessel revascularization (TVR)

    • Target vessel revascularization (TVR) at 6, 12 and 24 months

    Measured: 6, 12 and 24 months

  4. Binary restenosis rate

    • Binary restenosis rate at 6, 12 and 24 months.
    • Binary restenosis defined as > 50% diameter stenosis via angiography or PVR ≥ 2.4 via duplex ultrasound. In cases where results are available for both angiography and duplex ultrasound, angiographic results (if conducted within follow-up window) will be used to determine binary restenosis

    Measured: 6, 12 and 24 months

  5. Rutherford category

    Change of Rutherford category post index procedure and at 6, 12, and 24 months as compared to baseline

    Measured: 6, 12 and 24 months

  6. Ancle Brachial index (ABI)

    • Change in ABI at 6, 12, and 24 months as compared to baseline

    Measured: 6, 12 and 24 months

  7. Late lumen loss (LLL)

    • LLL at 24 months

    Measured: 24 months

  8. Minimum lumen diameter (MLD)

    • MLD at 12 and 24 months

    Measured: 12 and 24 months

  9. Hospitalization

    • Hospitalization (extra days due to complications of the index procedure) and hospitalization between the follow-up visits due to the index lesion and index leg

    Measured: 6, 12 and 24 months

  10. safety

    • Evaluation of 30 days freedom from procedure related death, unplanned amputation, and TLR.

    Measured: 30days

  11. resteosis pattern

    • Characterization of restenosis patterns between the two therapies

    Measured: 6 and 24 months

  12. Target lesion revascularization (TLR), clinical success and angiographic outcome (restenosis rate, late lumen loss) after second therapy

    clinical success, restensosis, TLR and LLL after second use of drug eluting balloons if initial therapy failed 30 days or later

    Measured: after intervention, 6, 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJan 2014 (estimated)
  4. Study completionJun 2016 (estimated)

Resources

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01594684
Sponsor's protocol ID
EK 11108
Status last verified
Jun 2012
First submitted
3 May 2012
Last updated
19 Jun 2012
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

  • Tepe G, Schroeder H, Albrecht T, Reimer P, Diehm N, Baeriswyl JL, Brechtel K, Speck U, Zeller T. Paclitaxel-Coated Balloon vs Uncoated Balloon Angioplasty for Treatment of In-Stent Restenosis in the Superficial Femoral and Popliteal Arteries: The COPA CABANA Trial. J Endovasc Ther. 2020 Apr;27(2):276-286. doi: 10.1177/1526602820907917. Epub 2020 Feb 25.

    PubMed 32096451

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing balloon angiolplasty - drug coated balloon (Cotavance, Medrad Inc.), drug coated balloon inflation (Cotavance, Medrad Inc.) and uncoated balloon (e.g. Admiral, Medtronic) in people with Catherization, run by Prof. Dr. med. Gunnar Tepe at 6 sites in Germany.

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 10 inclusion and 23 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 19 Jun 2012. 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 Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Late Lumen Loss (LLL) (time frame: 6 +/-2 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 NCT01594684, which also lists 2 linked publications.

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 19 Jun 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in