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

NCT ID: NCT01594684

Last Updated: 2012-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-06-30

Brief Summary

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

Conditions

Catherization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

drug eluting balloon

treatment with drug eltuing balloon

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

balloon inflation

drug coated balloon inflation (Cotavance, Medrad Inc.)

Intervention Type: DEVICE

Balloon inflation

uncoated balloon

treatment with uncoated balloon

Group Type: PLACEBO_COMPARATOR

uncoated balloon (e.g. Admiral, Medtronic)

Intervention Type: DEVICE

balloon inflation

double drug eluting balloon

if treatment fails 30 days or later

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

ballon inflation

Interventions

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

balloon inflation

Intervention Type: DEVICE

drug coated balloon inflation (Cotavance, Medrad Inc.)

Balloon inflation

Intervention Type: DEVICE

uncoated balloon (e.g. Admiral, Medtronic)

balloon inflation

Intervention Type: DEVICE

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

ballon inflation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. In-stent restenosis or re-occlusion at the target lesion due to an interventional treatment > 3 months prior to enrollment.

2. Has evidence of ≥ 70% stenosis or occlusion in the SFA and/or popliteal confirmed by angiography that is 3-27 cm long.

3. Reference vessel diameter of 3 to 7 mm (reference vessel diameter = normal vessel diameter 1 cm proximal of the index lesion)

4. Patients (men and women) with PAD disease category 2 to 5 according to Rutherford classification.

5. Patient is eligible for an operative vascular intervention in case of complications during the procedure.

6. Female patients of child bearing potential must have a negative pregnancy test 7 days at theprior to the time of intervention.

7. Fully informed and signed consent must be obtained from each patient.

8. 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.

9. 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.

10. 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)

Exclusion Criteria

1. 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)

2. Guidewire cannot cross lesion and/or an intentional subintimal approach in the stented lesion is required.

3. Patients with stent fractures grade 2-4.

4. Inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to treatment of the study lesion.

5. Acute thrombosis of the study lesion requiring lysis or thrombectomy prior to the treatment of the study lesion.

6. Acutely occurring symptoms with a lyses or an operation as a therapeutic option within the last 6 weeks within the study limb.

7. Potential loss of leg due to critical or acute ischemia.

8. No patent distal run-off vessel.

9. Aneurysm in the blood vessel intended for intervention in this study.

10. Blood platelet count < 100.000/mm3 or >700.000/mm3, leukocyte count < 3.000/mm3.

11. Contra-indication to anticoagulation, or any anti-platelet agent (e.g. aspirin, heparin, clopidogrel, ticlopidine, abciximab), or paclitaxel.

12. 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.

13. 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.

14. Manifest hyperthyreosis.

15. Latent hyperthyreosis without adequate therapy, e.g., previous blocking with Natriumperchlorat (Irenat®).

16. Significant gastrointestinal hemorrhage within the previous 6 months prior to study participation.

17. History of hemorrhagic diathesis or coagulopathy or rejection of blood transfusions.

18. Medical reason against double anti-platelet therapy in anti-coagulated patient, e.g., receiving coumadine.

19. 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.

20. Female patient who is pregnant or lactating.

21. Patient under 18 years of age.

22. Participation in another clinical study up to 30 days prior to study entry.

23. Previous participation in the same trialstudy (only one leg can be treated within the study).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zeller

UNKNOWN

Sponsor Role: collaborator

Duda

UNKNOWN

Sponsor Role: collaborator

Albrecht

UNKNOWN

Sponsor Role: collaborator

Reimer

UNKNOWN

Sponsor Role: collaborator

Brechtel

UNKNOWN

Sponsor Role: collaborator

Diehm

UNKNOWN

Sponsor Role: collaborator

Strausinsky

UNKNOWN

Sponsor Role: collaborator

Jahnke

UNKNOWN

Sponsor Role: collaborator

Huppert

UNKNOWN

Sponsor Role: collaborator

Amendt

UNKNOWN

Sponsor Role: collaborator

Prof. Dr. med. Gunnar Tepe

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Gunnar Tepe

Head of the Deparment of Diagnostic and Interventional Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Herzzentrum Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Tepe

Rosenheim, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Uniklinik Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Jüdisches Krankenhaus

Berlin, DE, Germany

Site Status: RECRUITING

Klinikum Neukölln

Berlin, DE, Germany

Site Status: RECRUITING

Klinikum Neumünster

Neumünster, Schleswig-Holstein, Germany

Site Status: RECRUITING

Countries

Germany

Facility Contacts

Thomas Zeller, MD

Role: primary

thomas.zeller@herzzentrum.de

076334022431

Gunnar Tepe, MD

Role: primary

gunnar.tepe@ro-med.de

80313653551

Klaus Brechtel, MD

Role: primary

klaus.brechtel@uni-tuebingen.de

070712983371

Stefan Duda, MD

Role: primary

stefan.duda@t-online.de

Thomas Albrecht, MD

Role: primary

thomas.albrecht@t-online.de

030-2983366

Thomas Jahnke, MD

Role: primary

thomas.jahnke@fek.de

04321 405-4910

References

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.

Reference Type: DERIVED

PMID: 32096451 (View on PubMed)

Other Identifiers

EK 11108

Identifier Type: -

Identifier Source: org_study_id