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

Completed

• Conditions: Chronic Total Occlusion
• Interventions: Device: Paclitaxel-coated Balloon dilation angioplasty; Device: Non-coated Balloon dilation angioplasty

• Registration Number: NCT05158686
• Lead Sponsor: Ignacio J. Amat Santos

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2020-10-01
• Study Completion: 2021-12-01
• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Paclitaxel-coated balloon angioplasty	Paclitaxel-coated Balloon dilation 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	Non-coated Balloon dilation angioplasty	Patients with previous failed recanalization of a CTO treated with non-coated balloon immediately proximal to the CTO during the index procedure

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Quality of life assessed by EQ5D questionnaire	6 months
Mortality after second attempt of CTO recanalization	6 months
Radiation during second attempt	6 months
Contrast administration during second attempt	6 months
Events at 1-year follow-up	1 year	All events including: Death, stroke, myocardial infarction (MI), target lesion revascularization (TLR), and contrast-induced nephropathy (CIN)
Procedural duration during second attempt	6 months

Trial Locations

Locations (1)

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain