Clinical trial NCT01594684: Cotavance™ Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Treatment of In-stent Restenosis in SFA and Popliteal Arteries
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Catherization
Keywords: restenosis
stent
drug eltuing balloon
peripheral arterial disease
Lead sponsor: Klinikum Rosenheim
Sponsor class: OTHER
Collaborators: name: Zeller
name: Duda
name: Albrecht
name: Reimer
name: Brechtel
name: Diehm
name: Strausinsky
name: Jahnke
name: Huppert
name: Amendt
First posted: 2012-05-09
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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).

Primary outcomes:
measure: Late Lumen Loss (LLL)
timeFrame: 6 +/-2 months
Secondary outcomes:
measure: • Procedural success
timeFrame: after intervention
measure: Target lesion revascularization (TLR)
timeFrame: 6, 12 and 24 months
measure: Target vessel revascularization (TVR)
timeFrame: 6, 12 and 24 months
measure: Binary restenosis rate
timeFrame: 6, 12 and 24 months
measure: Rutherford category
timeFrame: 6, 12 and 24 months
measure: Ancle Brachial index (ABI)
timeFrame: 6, 12 and 24 months
measure: Late lumen loss (LLL)
timeFrame: 24 months
measure: Minimum lumen diameter (MLD)
timeFrame: 12 and 24 months
measure: Hospitalization
timeFrame: 6, 12 and 24 months
measure: safety
timeFrame: 30days
measure: resteosis pattern
timeFrame: 6 and 24 months
measure: Target lesion revascularization (TLR), clinical success and angiographic outcome (restenosis rate, late lumen loss) after second therapy
timeFrame: after intervention, 6, 12 and 24 months
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
state: BW
city: Rosenheim
country: Germany
facility: Tepe
state: BW
city: Tuebingen
country: Germany
facility: Uniklinik Tübingen
state: BW
city: Berlin
country: Germany
facility: Jüdisches Krankenhaus
state: DE
city: Berlin
country: Germany
facility: Klinikum Neukölln
state: DE
city: Neumünster
country: Germany
facility: Klinikum Neumünster
state: SH
Study officials:
References:
citation: 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.