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| Name | Class |
|---|---|
| Zeller | UNKNOWN |
| Duda | UNKNOWN |
| Albrecht | UNKNOWN |
| Reimer |
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In stent restenosis in peripheral artery disease (superficial and popliteal artery) either treated with uncoated or paclitaxel coated balloons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| drug eluting balloon | Active Comparator | treatment with drug eltuing balloon |
|
| uncoated balloon | Placebo Comparator | treatment with uncoated balloon |
|
| double drug eluting balloon | Active Comparator | if treatment fails 30 days or later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balloon angiolplasty - drug coated balloon (Cotavance, Medrad Inc.) | Device | balloon inflation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| • Procedural success | • 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herzzentrum Bad Krozingen | Recruiting | Bad Krozingen | Baden-Wurttemberg | 73000 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32096451 | Derived | 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. |
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| Brechtel | UNKNOWN |
| Diehm | UNKNOWN |
| Strausinsky | UNKNOWN |
| Jahnke | UNKNOWN |
| Huppert | UNKNOWN |
| Amendt | UNKNOWN |
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| drug coated balloon inflation (Cotavance, Medrad Inc.) | Device | Balloon inflation |
|
| uncoated balloon (e.g. Admiral, Medtronic) | Device | balloon inflation |
|
| balloon inflation, drug coated balloon (Cotavance, Medrad Inc.) | Device | ballon inflation |
|
• 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) | • Target vessel revascularization (TVR) at 6, 12 and 24 months | 6, 12 and 24 months |
| Binary restenosis rate | • 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 | 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) | • Change in ABI at 6, 12, and 24 months as compared to baseline | 6, 12 and 24 months |
| Late lumen loss (LLL) | • LLL at 24 months | 24 months |
| Minimum lumen diameter (MLD) | • MLD at 12 and 24 months | 12 and 24 months |
| Hospitalization | • 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 | • Evaluation of 30 days freedom from procedure related death, unplanned amputation, and TLR. | 30days |
| resteosis pattern | • 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 | 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 |
| Tepe | Recruiting | Rosenheim | Baden-Wurttemberg | 83022 | Germany |
|
| Uniklinik Tübingen | Recruiting | Tübingen | Baden-Wurttemberg | 73022 | Germany |
|
| Jüdisches Krankenhaus | Recruiting | Berlin | DE | 0001 | Germany |
|
| Klinikum Neukölln | Recruiting | Berlin | DE | 0001 | Germany |
|
| Klinikum Neumünster | Recruiting | Neumünster | Schleswig-Holstein | 24534 | Germany |
|
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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