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Observational retrospective registry to compare effectiveness of paclitaxel-coated vs. non coated balloon angioplasty proximal to a Chronic Total Occlussion (CTO) after failed revascularization. Primary objective is to determine success rate after repeated percutaneous coronary intervention of a CTO 3 to 6 months after paclitaxel-coated balloon angioplasty proximal to the persistent lesion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel-coated balloon angioplasty | Patients with previous failed recanalization of a CTO treated with paclitaxel coated balloon immediately proximal to the CTO during the index procedure |
| |
| Non-coated balloon angioplasty | Patients with previous failed recanalization of a CTO treated with non-coated balloon immediately proximal to the CTO during the index procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel-coated Balloon dilation angioplasty | Device | Paclitaxel-coated ballon dilation angioplasty proximal to CTO lesion after failed percutaneous recanalization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success of repeated percutaneous coronary intervention of a CTO 3 to 6 months after balloon angioplasty proximal to the persistent lesion. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality after second attempt of CTO recanalization | 6 months | |
| Quality of life assessed by EQ5D questionnaire | 6 months | |
| Procedural duration during second attempt |
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Inclusion Criteria:
Exclusion Criteria:
- Unfeasible recanalization of the CTO according to the interventional cardiologists of the center.
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Patients with coronary angiography in which percutaneous coronary intervention results in failure during treatment of a CTO. Indication of the procedures will be clinically driven. Informed consent will be provided after the first failed attempt of CTO recanalization.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClĂnico Universitario de Valladolid | Valladolid | Spain |
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| Non-coated Balloon dilation angioplasty | Device | Non-coated ballon dilation angioplasty proximal to CTO lesion after failed percutaneous recanalization |
|
| 6 months |
| Radiation during second attempt | 6 months |
| Contrast administration during second attempt | 6 months |
| Events at 1-year follow-up | All events including: Death, stroke, myocardial infarction (MI), target lesion revascularization (TLR), and contrast-induced nephropathy (CIN) | 1 year |