Use of Drug-Coated Balloon to Improve Recanalization of a Coronary Chronic Total Occlusion After Failed Angioplasty

Study Overview
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Brief Summary
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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.

Official Title
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Use of Drug-Coated Balloon to Improve Recanalization of a Coronary Chronic Total Occlusion After Failed Angioplasty: The IMPROVED-RECTO Trial.

Conditions
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Chronic Total Occlusion

Intervention / Treatment
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* Device: Paclitaxel-coated Balloon dilation angioplasty
* Device: Non-coated Balloon dilation angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Failed recanalization of a CTO in patients with clinical indication for the percutaneous procedure. Patient willing to participate in the study providing signed informed consent. J-CTO Score ≥2. Exclusion Criteria: - Unfeasible recanalization of the CTO according to the interventional cardiologists of the center.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paclitaxel-coated balloon angioplasty<br>Patients with previous failed recanalization of a CTO treated with paclitaxel coated balloon immediately proximal to the CTO during the index procedure | Device: Paclitaxel-coated Balloon dilation angioplasty<br>* Paclitaxel-coated ballon dilation angioplasty proximal to CTO lesion after failed percutaneous recanalization<br>|
| Non-coated balloon angioplasty<br>Patients with previous failed recanalization of a CTO treated with non-coated balloon immediately proximal to the CTO during the index procedure | Device: Non-coated Balloon dilation angioplasty<br>* Non-coated ballon dilation angioplasty proximal to CTO lesion after failed percutaneous recanalization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Repeated procedure, Angioplasty, Paclitaxel, drug-coated balloon