- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01594684
Cotavance™ Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Treatment of In-stent Restenosis in SFA and Popliteal Arteries
June 16, 2012 updated by: Prof. Dr. med. Gunnar Tepe
Cotavance™ Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Treatment of In-stent Restenosis in SFA and Popliteal Arteries COPA CABANA Study
In stent restenosis in peripheral artery disease (superficial and popliteal artery) either treated with uncoated or paclitaxel coated balloons.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
112
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
BW
-
Bad Krozingen, BW, Germany, 73000
- Recruiting
- Herzzentrum Bad Krozingen
-
Rosenheim, BW, Germany, 83022
- Recruiting
- Tepe
-
Tuebingen, BW, Germany, 73022
- Recruiting
- Uniklinik Tübingen
-
Contact:
- Klaus Brechtel, MD
- Phone Number: 070712983371
- Email: klaus.brechtel@uni-tuebingen.de
-
-
DE
-
Berlin, DE, Germany, 0001
- Recruiting
- Judisches Krankenhaus
-
Contact:
- Stefan Duda, MD
- Email: stefan.duda@t-online.de
-
Principal Investigator:
- Stefan Duda, MD
-
Berlin, DE, Germany, 0001
- Recruiting
- Klinikum Neukölln
-
Contact:
- Thomas Albrecht, MD
- Phone Number: 030-2983366
- Email: thomas.albrecht@t-online.de
-
Principal Investigator:
- Thomas Albrecht, MD
-
-
SH
-
Neumünster, SH, Germany, 24534
- Recruiting
- Klinikum Neumünster
-
Contact:
- Thomas Jahnke, MD
- Phone Number: 04321 405-4910
- Email: thomas.jahnke@fek.de
-
Principal Investigator:
- Thomas Jahnke, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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®).
- Significant gastrointestinal hemorrhage within the previous 6 months prior to study participation.
- History of hemorrhagic diathesis or coagulopathy or rejection of blood transfusions.
- Medical reason against double anti-platelet therapy in anti-coagulated patient, e.g., receiving coumadine.
- 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.
- Female patient who is pregnant or lactating.
- Patient under 18 years of age.
- Participation in another clinical study up to 30 days prior to study entry.
- Previous participation in the same trialstudy (only one leg can be treated within the study).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: drug eluting balloon
treatment with drug eltuing balloon
|
balloon inflation
Balloon inflation
|
Placebo Comparator: uncoated balloon
treatment with uncoated balloon
|
balloon inflation
|
Active Comparator: double drug eluting balloon
if treatment fails 30 days or later
|
ballon inflation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 +/-2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
• 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)
|
after intervention
|
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.
|
6, 12 and 24 months
|
Target vessel revascularization (TVR)
Time Frame: 6, 12 and 24 months
|
• Target vessel revascularization (TVR) at 6, 12 and 24 months
|
6, 12 and 24 months
|
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 |
6, 12 and 24 months
|
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, 12 and 24 months
|
Ancle Brachial index (ABI)
Time Frame: 6, 12 and 24 months
|
• Change in ABI at 6, 12, and 24 months as compared to baseline
|
6, 12 and 24 months
|
Late lumen loss (LLL)
Time Frame: 24 months
|
• LLL at 24 months
|
24 months
|
Minimum lumen diameter (MLD)
Time Frame: 12 and 24 months
|
• MLD at 12 and 24 months
|
12 and 24 months
|
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
|
6, 12 and 24 months
|
safety
Time Frame: 30days
|
• Evaluation of 30 days freedom from procedure related death, unplanned amputation, and TLR.
|
30days
|
resteosis pattern
Time Frame: 6 and 24 months
|
• Characterization of restenosis patterns between the two therapies
|
6 and 24 months
|
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
|
after intervention, 6, 12 and 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
January 1, 2014
Study Completion (Anticipated)
June 1, 2016
Study Registration Dates
First Submitted
May 3, 2012
First Submitted That Met QC Criteria
May 8, 2012
First Posted (Estimate)
May 9, 2012
Study Record Updates
Last Update Posted (Estimate)
June 19, 2012
Last Update Submitted That Met QC Criteria
June 16, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- EK 11108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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