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

NCT01594684 | Unknown Phase 2

• 1 other identifier: EK 11108
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Catherization

Keywords

restenosis; stent; drug eltuing balloon; peripheral arterial disease

Outcome Measures

Primary Outcomes (1)

• Late Lumen Loss (LLL)

  • 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

  6 +/-2 months

Secondary Outcomes (12)

• • Procedural success

  after intervention

• Target lesion revascularization (TLR)

  6, 12 and 24 months

• Target vessel revascularization (TVR)

  6, 12 and 24 months

• Binary restenosis rate

  6, 12 and 24 months

• Rutherford category

  6, 12 and 24 months

Study Arms (3)

drug eluting balloon

ACTIVE COMPARATOR

treatment with drug eltuing balloon

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

uncoated balloon

PLACEBO COMPARATOR

treatment with uncoated balloon

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

double drug eluting balloon

ACTIVE COMPARATOR

if treatment fails 30 days or later

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

Interventions

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

balloon inflation

drug eluting balloon

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

Balloon inflation

drug eluting balloon

uncoated balloon (e.g. Admiral, Medtronic) DEVICE

balloon inflation

uncoated balloon

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

ballon inflation

double drug eluting balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In-stent restenosis or re-occlusion at the target lesion due to an interventional treatment \> 3 months prior to enrollment.
• Has evidence of ≥ 70% stenosis or occlusion in the SFA and/or popliteal confirmed by angiography that is 3-27 cm long.
• Reference vessel diameter of 3 to 7 mm (reference vessel diameter = normal vessel diameter 1 cm proximal of the index lesion)
• Patients (men and women) with PAD disease category 2 to 5 according to Rutherford classification.
• Patient is eligible for an operative vascular intervention in case of complications during the procedure.
• Female patients of child bearing potential must have a negative pregnancy test 7 days at theprior to the time of intervention.
• Fully informed and signed consent must be obtained from each patient.
• 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.
• 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.
• 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)

You may not qualify if:

• 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)
• Guidewire cannot cross lesion and/or an intentional subintimal approach in the stented lesion is required.
• Patients with stent fractures grade 2-4.
• Inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to treatment of the study lesion.
• Acute thrombosis of the study lesion requiring lysis or thrombectomy prior to the treatment of the study lesion.
• Acutely occurring symptoms with a lyses or an operation as a therapeutic option within the last 6 weeks within the study limb.
• Potential loss of leg due to critical or acute ischemia.
• No patent distal run-off vessel.
• Aneurysm in the blood vessel intended for intervention in this study.
• Blood platelet count \< 100.000/mm3 or \>700.000/mm3, leukocyte count \< 3.000/mm3.
• Contra-indication to anticoagulation, or any anti-platelet agent (e.g. aspirin, heparin, clopidogrel, ticlopidine, abciximab), or paclitaxel.
• 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.
• 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.
• Manifest hyperthyreosis.
• Latent hyperthyreosis without adequate therapy, e.g., previous blocking with Natriumperchlorat (Irenat®).

Sponsors & Collaborators

• Prof. Dr. med. Gunnar Tepe: lead
• Zeller: collaborator
• Duda: collaborator
• Albrecht: collaborator
• Reimer: collaborator
• Brechtel: collaborator
• Diehm: collaborator
• Strausinsky: collaborator
• Jahnke: collaborator
• Huppert: collaborator
• Amendt: collaborator

Study Sites (6)

Herzzentrum Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, 73000, Germany

RECRUITING

Tepe

Rosenheim, Baden-Wurttemberg, 83022, Germany

RECRUITING

Uniklinik Tübingen

Tübingen, Baden-Wurttemberg, 73022, Germany

RECRUITING

Jüdisches Krankenhaus

Berlin, DE, 0001, Germany

RECRUITING

Klinikum Neukölln

Berlin, DE, 0001, Germany

RECRUITING

Klinikum Neumünster

Neumünster, Schleswig-Holstein, 24534, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 32096451 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Deparment of Diagnostic and Interventional Radiology

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 9, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2016
• Last Updated: June 19, 2012

Record last verified: 2012-06

Locations

DE (6)