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

April 21, 2022 updated by: Ignacio J. Amat Santos

Use of Drug-Coated Balloon to Improve Recanalization of a Coronary Chronic Total Occlusion After Failed Angioplasty: The IMPROVED-RECTO Trial.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valladolid, Spain
        • Hospital Clínico Universitario de Valladolid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Device: Non-coated Balloon dilation angioplasty
Non-coated ballon dilation angioplasty proximal to CTO lesion after failed percutaneous recanalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ignacio J. Amat Santos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

December 2, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICICOR-IMPROVED-RECTO-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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