Long-term Clinical Follow up After PCI for CTO (LT-CTO)

August 5, 2024 updated by: University Hospital, Montpellier
The research aimed to evaluate the impact of a successful Percutaneous coronary intervention of chronic total occlusions (CTO-PCI) on long-term MACE (Major Cardiovascular Events), symptoms, survival, Left Ventricular Ejection Fraction (LVEF) and myocardial ischemia up-to-8-years follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With this observational and prospective study, this research aimed to evaluate the impact of a successful CTO-PCI on long-term MACE (Major Cardiovascular Events), symptoms, survival, LVEF and myocardial ischemia up-to-8-years follow-up.

Study Type

Observational

Enrollment (Actual)

463

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

  • France
    • Herault
      • Montpellier, Herault, France, 34090
        • CHU Montpellier

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who underwent an attempt of percutaneous recanalization of a CTO at Montpellier University Hospital between January 2015 and December 2022. All patients had symptoms (angina or dyspnea) and/or reversible myocardial ischemia in the territory of the occluded artery and myocardial viability

Description

Inclusion Criteria:

  • 18 years or older
  • who underwent at least one CTO procedure between 2025 and 2022 in Montpellier University Hospital
  • symptomatic of reversible myocardial ischemia
  • proof of myocardial viability

Exclusion Criteria:

  • refusal of the patient to participate to the study

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
PCI-CTO
All patients who underwent an attempt of percutaneous recanalization of a CTO.
Other: Percutaneous Coronary Intervention of CTO
CTO-PCI is a procedure of interventional cardiology attempting revascularisation of the CTO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major cardiovascular events (MACE)
Time Frame: Up to 8 years
Incidence of composite of cardiac death, non-fatal myocardial infarction and new target vessel revascularization
Up to 8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non combined MACE components
Time Frame: Up to 8 years
Incidence of Cardiac death, non-fatal myocardial infarction and new target vessel revascularization
Up to 8 years
In-hospital events
Time Frame: Up to one week
Incidence of Procedural complications including death, periprocedural MI, coronary perforation, pericardial tamponade requiring drainage, local vascular complications, major bleeding, contrast induced nephropathy, stroke
Up to one week
Restenosis
Time Frame: Up to 8 years
Incidence of Restenosis Defined as a greater than 50% diameter stenosis at follow-up angiogram of the first dilated total occlusion. Reocclusion was defined as recurrent total occlusion of the first dilated total occlusion.
Up to 8 years
Ischemic burden
Time Frame: Up to 8 years
Comparison between pre and post-CTO ischemic tests
Up to 8 years
Stent thrombosis
Time Frame: Within 30 days after the procedure
Incidence of stent thrombosis defined as any myocardial infarction with angiographic confirmation of in-stent thrombus or unexplained death
Within 30 days after the procedure
LVEF
Time Frame: Up to 8 years
Percentage of Increase or decrease in LVEF after the CTO procedure compared with baseline LVEF
Up to 8 years

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

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)

November 1, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-01-008 ARNOLD

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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