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

• ClinicalTrials.gov Identifier: NCT01594684
• Recruitment Status: Unknown
• First Posted: May 9, 2012
• Last Update Posted: June 19, 2012
• Sponsor: Prof. Dr. med. Gunnar Tepe
• Collaborators: Zeller; Duda; Albrecht; Reimer; Brechtel; Diehm; Strausinsky; Jahnke; Huppert; Amendt
• Information provided by (Responsible Party): Prof. Dr. med. Gunnar Tepe, Klinikum Rosenheim

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Catherization	Device: balloon angiolplasty - drug coated balloon (Cotavance, Medrad Inc.); Device: drug coated balloon inflation (Cotavance, Medrad Inc.); Device: uncoated balloon (e.g. Admiral, Medtronic); Device: balloon inflation, drug coated balloon (Cotavance, Medrad Inc.)	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Cotavance™ Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Treatment of In-stent Restenosis in SFA and Popliteal Arteries COPA CABANA Study
• Study Start Date: January 2012
• Estimated Primary Completion Date: January 2014
• Estimated Study Completion Date: June 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: drug eluting balloon; treatment with drug eltuing balloon	Device: balloon angiolplasty - drug coated balloon (Cotavance, Medrad Inc.); balloon inflation; Device: drug coated balloon inflation (Cotavance, Medrad Inc.); Balloon inflation
Placebo Comparator: uncoated balloon; treatment with uncoated balloon	Device: uncoated balloon (e.g. Admiral, Medtronic); balloon inflation
Active Comparator: double drug eluting balloon; if treatment fails 30 days or later	Device: balloon inflation, drug coated balloon (Cotavance, Medrad Inc.); ballon inflation

Outcome Measures

Primary Outcome Measures :

1. Late Lumen Loss (LLL) [ Time Frame: 6 +/-2 months ]
   • 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

Secondary Outcome Measures :

1. • Procedural success [ Time Frame: after intervention ]
   • Procedural success defined as ≤ 30% residual stenosis following the procedure at the target lesion (after prolonged dilation and stenting, if necessary)
2. Target lesion revascularization (TLR) [ Time Frame: 6, 12 and 24 months ]
   • 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.
3. Target vessel revascularization (TVR) [ Time Frame: 6, 12 and 24 months ]
   • Target vessel revascularization (TVR) at 6, 12 and 24 months
4. Binary restenosis rate [ Time Frame: 6, 12 and 24 months ]

   • Binary restenosis rate at 6, 12 and 24 months.

   o 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

5. Rutherford category [ Time Frame: 6, 12 and 24 months ]
   Change of Rutherford category post index procedure and at 6, 12, and 24 months as compared to baseline
6. Ancle Brachial index (ABI) [ Time Frame: 6, 12 and 24 months ]
   • Change in ABI at 6, 12, and 24 months as compared to baseline
7. Late lumen loss (LLL) [ Time Frame: 24 months ]
   • LLL at 24 months
8. Minimum lumen diameter (MLD) [ Time Frame: 12 and 24 months ]
   • MLD at 12 and 24 months
9. Hospitalization [ Time Frame: 6, 12 and 24 months ]
   • 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
10. safety [ Time Frame: 30days ]
    • Evaluation of 30 days freedom from procedure related death, unplanned amputation, and TLR.
11. resteosis pattern [ Time Frame: 6 and 24 months ]
    • Characterization of restenosis patterns between the two therapies
12. Target lesion revascularization (TLR), clinical success and angiographic outcome (restenosis rate, late lumen loss) after second therapy [ Time Frame: after intervention, 6, 12 and 24 months ]
    clinical success, restensosis, TLR and LLL after second use of drug eluting balloons if initial therapy failed 30 days or later

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

Germany

Herzzentrum Bad Krozingen; Recruiting

Bad Krozingen, BW, Germany, 73000

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

Principal Investigator: Thomas Zeller, MD

Tepe; Recruiting

Rosenheim, BW, Germany, 83022

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

Principal Investigator: Gunnar Tepe, MD

Uniklinik Tübingen; Recruiting

Tuebingen, BW, Germany, 73022

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

Jüdisches Krankenhaus; Recruiting

Berlin, DE, Germany, 0001

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

Principal Investigator: Stefan Duda, MD

Klinikum Neukölln; Recruiting

Berlin, DE, Germany, 0001

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

Principal Investigator: Thomas Albrecht, MD

Klinikum Neumünster; Recruiting

Neumünster, SH, Germany, 24534

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

Principal Investigator: Thomas Jahnke, MD

Sponsors and Collaborators

Prof. Dr. med. Gunnar Tepe

Zeller

Duda

Albrecht

Reimer

Brechtel

Diehm

Strausinsky

Jahnke

Huppert

Amendt

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum in: J Endovasc Ther. 2020 Apr;27(2):350.

• Responsible Party: Prof. Dr. med. Gunnar Tepe, Head of the Deparment of Diagnostic and Interventional Radiology, Klinikum Rosenheim
• ClinicalTrials.gov Identifier: NCT01594684
• Other Study ID Numbers: EK 11108
• First Posted: May 9, 2012
• Last Update Posted: June 19, 2012
• Last Verified: June 2012

Keywords provided by Prof. Dr. med. Gunnar Tepe, Klinikum Rosenheim:

restenosis; stent; drug eltuing balloon; peripheral arterial disease