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

Ignacio J. Amat Santos

Status: Completed

Conditions: Chronic Total Occlusion

Treatments: Device: Paclitaxel-coated Balloon dilation angioplasty; Device: Non-coated Balloon dilation angioplasty

Study type: Observational

Funder types: Other

Identifiers

NCT05158686

ICICOR-IMPROVED-RECTO-2021

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

44 participants in 2 patient groups

Paclitaxel-coated balloon angioplasty

Description:

Patients with previous failed recanalization of a CTO treated with paclitaxel coated balloon immediately proximal to the CTO during the index procedure

Treatment:

Device: Paclitaxel-coated Balloon dilation angioplasty

Non-coated balloon angioplasty

Description:

Patients with previous failed recanalization of a CTO treated with non-coated balloon immediately proximal to the CTO during the index procedure

Treatment:

Device: Non-coated Balloon dilation angioplasty