Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization (HCR registry)

December 22, 2023 updated by: Seung-Jung Park

Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization, a Non-randomized, Prospective, Open-label Registry in Real-world Practice

This study evaluated the effectiveness and safety of Hybrid Coronary Revascularization in real-world practice.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

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

Study Contact

Study Locations

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with hybrid coronary revascularization due to multivessel coronary artery disease(must include left anterior descending artery)

Description

Inclusion Criteria:

  • Age 20 and more
  • Hybrid coronary revascularization due to multivessel coronary artery disease(must include left anterior descending artery)
  • Written consent

Exclusion Criteria:

  • Previous CABG(coronary artery bypass graft)
  • Life expectancy ≤1 year

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
Multivessel coronary artery disease
must include left anterior descending artery
Procedure: Hybrid Coronary Revascularization
Hybrid coronary revascularization (HCR) combines minimally invasive surgical coronary artery bypass grafting of the left anterior descending artery with percutaneous coronary intervention (PCI) of non-left anterior descending vessels.
Other Names:
  • HCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
a composite event of death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke.
Time Frame: 5 years
Patients who have experienced any one of the following events are considered to have experienced the composite outcome: death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac death
Time Frame: 5 years
5 years
All death
Time Frame: 5 years
5 years
Myocardial infarction
Time Frame: 5 years
5 years
a composite event of all death or myocardial infarction
Time Frame: 5 years
5 years
a composite event of cardiac death or myocardial infarction
Time Frame: 5 years
5 years
TVR(Target Vessel Revascularization)
Time Frame: 5 years
5 years
TLR(Target Lesion Revascularization)
Time Frame: 5 years
5 years
Stent thrombosis
Time Frame: 5 years
by an Academic Research Consortium (ARC) category
5 years
Cerebrovascular event
Time Frame: 5 years
5 years
Procedural success
Time Frame: 5 days
Procedural success is defined as < 30% final stenosis and the absence of in-hospital event including death, Q-wave myocardial infarction or urgent repeat revascularization.
5 days

Collaborators and Investigators

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

Sponsor

Seung-Jung Park

Collaborators

CardioVascular Research Foundation, Korea

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)

April 5, 2019

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

December 21, 2018

First Submitted That Met QC Criteria

December 25, 2018

First Posted (Actual)

December 27, 2018

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV2018-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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