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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Klinikum Rosenheim
Sponsor:
Collaborators:
Zeller
Duda
Albrecht
Reimer
Brechtel
Diehm
Strausinsky
Jahnke
Huppert
Amendt
Information provided by (Responsible Party):
Prof. Dr. med. Gunnar Tepe, Klinikum Rosenheim
ClinicalTrials.gov Identifier:
NCT01594684
First received: May 3, 2012
Last updated: June 16, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Klinikum Rosenheim:

Primary Outcome Measures:
  • Late Lumen Loss (LLL) [ Time Frame: 6 +/-2 months ] [ Designated as safety issue: Yes ]
    • 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:
  • • Procedural success [ Time Frame: after intervention ] [ Designated as safety issue: Yes ]
    • Procedural success defined as ≤ 30% residual stenosis following the procedure at the target lesion (after prolonged dilation and stenting, if necessary)

  • Target lesion revascularization (TLR) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
    • 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.

  • Target vessel revascularization (TVR) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
    • Target vessel revascularization (TVR) at 6, 12 and 24 months

  • Binary restenosis rate [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]

    • 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


  • Rutherford category [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
    Change of Rutherford category post index procedure and at 6, 12, and 24 months as compared to baseline

  • Ancle Brachial index (ABI) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
    • Change in ABI at 6, 12, and 24 months as compared to baseline

  • Late lumen loss (LLL) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    • LLL at 24 months

  • Minimum lumen diameter (MLD) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: Yes ]
    • MLD at 12 and 24 months

  • Hospitalization [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
    • 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

  • safety [ Time Frame: 30days ] [ Designated as safety issue: Yes ]
    • Evaluation of 30 days freedom from procedure related death, unplanned amputation, and TLR.

  • resteosis pattern [ Time Frame: 6 and 24 months ] [ Designated as safety issue: Yes ]
    • Characterization of restenosis patterns between the two therapies

  • 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 ] [ Designated as safety issue: Yes ]
    clinical success, restensosis, TLR and LLL after second use of drug eluting balloons if initial therapy failed 30 days or later


Estimated Enrollment: 112
Study Start Date: January 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594684

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

No publications provided

Responsible Party: Prof. Dr. med. Gunnar Tepe, Head of the Deparment of Diagnostic and Interventional Radiology, Klinikum Rosenheim
ClinicalTrials.gov Identifier: NCT01594684     History of Changes
Other Study ID Numbers: EK 11108
Study First Received: May 3, 2012
Last Updated: June 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Klinikum Rosenheim:
restenosis
stent
drug eltuing balloon
peripheral arterial disease

ClinicalTrials.gov processed this record on September 16, 2014