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

NCT ID: NCT05158686

Last Updated: 2022-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-12-01

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.

Detailed Description

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Conditions

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Chronic Total Occlusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Paclitaxel-coated Balloon dilation angioplasty

Intervention Type DEVICE

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

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

Non-coated Balloon dilation angioplasty

Intervention Type DEVICE

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

Interventions

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Paclitaxel-coated Balloon dilation angioplasty

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

Intervention Type DEVICE

Non-coated Balloon dilation angioplasty

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

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ignacio J. Amat Santos

OTHER

Sponsor Role lead

Responsible Party

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Ignacio J. Amat Santos

Coordinator of Interventional Cardiology Unit

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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ICICOR-IMPROVED-RECTO-2021

Identifier Type: -

Identifier Source: org_study_id

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