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The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard PTA | Active Comparator | nitinol stent implantation |
|
| DEB | Experimental | paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation | Device | paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| angiographic binary restenosis | incidence of binary restenosis | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| major amputation | incidence of major amputation | 24 months |
| target lesion revascularization | incidence of target lesion revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Liistro, MD | Cardiovascular Department, San Donato Hospital, Arezzo, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Department, Ospedale S.Donato | Arezzo | AR | 52100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24239203 | Derived | Liistro F, Grotti S, Porto I, Angioli P, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery). JACC Cardiovasc Interv. 2013 Dec;6(12):1295-302. doi: 10.1016/j.jcin.2013.07.010. Epub 2013 Nov 13. |
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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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| nitinol stent implantation | Device | nitinol stent implantation |
|
| 24 months |
| vessel reocclusion | incidence of vessel reocclusion | 24 months |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |