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

Ignacio J. Amat Santos44 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Total Occlusion

Interventions

Paclitaxel-coated Balloon dilation angioplastyDEVICE

Paclitaxel-coated ballon dilation angioplasty proximal to CTO lesion after failed percutaneous recanalization

Non-coated Balloon dilation angioplastyDEVICE

Non-coated ballon dilation angioplasty proximal to CTO lesion after failed percutaneous recanalization

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Outcomes

Primary Outcomes

Success of repeated percutaneous coronary intervention of a CTO 3 to 6 months after balloon angioplasty proximal to the persistent lesion.

Time frame: 6 months

Secondary Outcomes

Mortality after second attempt of CTO recanalization

Time frame: 6 months

Quality of life assessed by EQ5D questionnaire

Time frame: 6 months

Procedural duration during second attempt

Time frame: 6 months

Radiation during second attempt

Time frame: 6 months

Contrast administration during second attempt

Time frame: 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)

Time frame: 1 year

Data from ClinicalTrials.gov

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