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

Prof. Dr. med. Gunnar Tepe

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Catherization

Treatments: Device: balloon inflation, drug coated balloon (Cotavance, Medrad Inc.); Device: balloon angiolplasty - drug coated balloon (Cotavance, Medrad Inc.); Device: uncoated balloon (e.g. Admiral, Medtronic); Device: drug coated balloon inflation (Cotavance, Medrad Inc.)

Study type: Interventional

Funder types: Other

Identifiers

NCT01594684

EK 11108

Details and patient eligibility

About

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

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 3 patient groups, including a placebo group

drug eluting balloon

Active Comparator group

Description:

treatment with drug eltuing balloon

Treatment:

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

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

uncoated balloon

Placebo Comparator group

Description:

treatment with uncoated balloon

Treatment:

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

double drug eluting balloon

Active Comparator group

Description:

if treatment fails 30 days or later

Treatment:

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