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Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK) vessels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard PTA | Active Comparator | conventional balloon angioplasty |
|
| Drug-eluting balloon angioplasty | Experimental | paclitaxel-eluting balloon angioplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEB | Device | paclitaxel-eluting balloon angioplasty |
| |
| Measure | Description | Time Frame |
|---|---|---|
| angiographic binary restenosis | incidence of binary restenosis | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| major amputation | incidence of major amputation | 24 motnhs |
| target lesion revascularization | incidence of target lesion revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Department, Ospedale S.Donato | Arezzo | AR | 52100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23797811 | Derived | Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013 Aug 6;128(6):615-21. doi: 10.1161/CIRCULATIONAHA.113.001811. |
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| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| POBA |
| Device |
conventional balloon angioplasty |
|
| 24 months |
| vessel reocclusion | incidence of vessel reocclusion | 24 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |