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slow enrollment
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The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed versus conventional balloon angioplasty in superficial femoral artery and popliteal artery re-stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEB | paclitaxel-eluting balloon angioplasty |
| |
| conventional PTA | historical conventional balloon angioplasty control group (patients referred to our institution between 2008 and 2009) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEB | Device | paclitaxel-eluting balloon angioplasty |
| |
| POBA |
| Measure | Description | Time Frame |
|---|---|---|
| angiographic binary re-restenosis | incidence of angiographic binary re-restenosis | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| major amputation | incidence of major amputation | 24 months |
| stent thrombosis | incidence of stent thrombosis | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients referring to our institution for peripheral artery disease
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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 |
|---|---|---|---|
| 26511896 | Derived | Grotti S, Liistro F, Angioli P, Ducci K, Falsini G, Porto I, Ricci L, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel-Eluting Balloon vs Standard Angioplasty to Reduce Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: Three-Year Results of the DEBATE-ISR Study. J Endovasc Ther. 2016 Feb;23(1):52-7. doi: 10.1177/1526602815614555. Epub 2015 Oct 28. | |
| 24502477 |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Device |
conventional balloon angioplasty |
|
| target lesion revascularization | incidence of target lesion revascularization | 24 months |
| Derived |
| Liistro F, Angioli P, Porto I, Ricci L, Ducci K, Grotti S, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel-eluting balloon vs. standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: the DEBATE-ISR study. J Endovasc Ther. 2014 Feb;21(1):1-8. doi: 10.1583/13-4420R.1. |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |