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

NCT05158686 | Completed

• 1 other identifier: ICICOR-IMPROVED-RECTO-2021
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Total Occlusion

Keywords

Repeated procedure, Angioplasty, Paclitaxel, drug-coated balloon

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (6)

• 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

Study Arms (2)

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

Device: Paclitaxel-coated Balloon dilation angioplasty

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

Device: Non-coated Balloon dilation angioplasty

Interventions

Paclitaxel-coated Balloon dilation angioplasty DEVICE

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

Paclitaxel-coated balloon angioplasty

Non-coated Balloon dilation angioplasty DEVICE

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

Non-coated balloon angioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• \- Unfeasible recanalization of the CTO according to the interventional cardiologists of the center.

Sponsors & Collaborators

• Ignacio J. Amat Santos: lead

Study Sites (1)

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinator of Interventional Cardiology Unit

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: October 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2021
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)