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This is a multicentric randomized comparison between paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in patients with stable or unstable angina with the evaluation of restenosis by Quantitative Coronary Analysis.
The purpose of this study is to determine the late luminal loss by Quantitative Coronary Analysis at 6 month-follow up after paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in the treatment of in-stent restenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel-coated Balloon | Experimental | Paclitaxel-coated Balloon Angioplasty |
|
| Paclitaxel-eluting Stent | Active Comparator | Paclitaxel-eluting Stent Implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel-coated Balloon | Procedure | POBA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late Luminal Loss defined as the difference between the minimal luminal diameter after stenting and at follow-up by Quantitative Coronary Analysis | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Binary restenosis defined as >50% diameter stenosis by QCA | 6 months | |
| Major Adverse Cardiac Events | 6, 12 months | |
| Target Lesion Revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonardo Bolognese, MD | Cardiovascular Department - San Donato Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Donato Hospital | Arezzo | AR | 52100 | Italy |
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| Paclitaxel-eluting Stent | Device | Stenting |
|
|
| 6, 12 months |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000789 | Angina, Unstable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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