- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07373678
CABG Versus PCI in Patients With Isolated LAD Chronic Total Occlusion (RITUAL)
Coronary Artery Bypass Surgery Versus Percutaneous Coronary Intervention in Patients With Isolated Chronic Total Occlusion of the Left Anterior Descending Artery: The RITUAL Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic total occlusion (CTO) represents one of the most challenging subgroups of coronary artery disease and is closely associated with adverse cardiovascular outcomes. Previous studies have demonstrated that patients with CTO experience a higher incidence of major adverse cardiovascular events compared with patients without CTO but with significant coronary artery disease (CAD), even after adjustment for demographic characteristics, clinical parameters, and disease severity. Among these patients, those with unrevascularized CTO constitute the highest-risk group, whereas successful revascularization has been shown to reduce the risk to a level comparable to that of patients without CTO but with significant CAD.
Among CTOs, isolated total occlusion of the left anterior descending (LAD) artery has particular clinical importance due to its critical role in myocardial perfusion. Two main revascularization strategies are currently used in the treatment of isolated LAD CTO: percutaneous coronary intervention (PCI) and single-vessel coronary artery bypass grafting (CABG). In surgical revascularization, the left internal mammary artery (LIMA) is most commonly used, although saphenous vein grafts may be preferred in selected cases.
However, direct comparative data between these two treatment strategies in this specific patient population remain extremely limited. In particular, differences between CTO-PCI and single-vessel CABG with respect to revascularization success, in-hospital events, and early post-discharge outcomes have not been systematically evaluated. In the present study, within the framework of the RITUAL study, the outcomes of CTO-PCI and CABG surgery were compared in patients with isolated LAD CTO.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Mersin, Turkey (Türkiye), 33010
- Sefa SURAL
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years or older at the time of the index procedure.
- Diagnosis of isolated chronic total occlusion (CTO) of the left anterior descending (LAD) coronary artery.
- Isolated LAD CTO defined as a de novo or in-stent total occlusion confined to the LAD artery, without significant coronary artery disease (defined as ≥50% stenosis) in other major epicardial coronary arteries, including the left circumflex (LCx), right coronary artery (RCA), or major side branches.
- No prior percutaneous coronary intervention (PCI) performed in non-LAD coronary arteries.
- Patients who underwent coronary revascularization with either coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) for isolated LAD CTO.
Exclusion Criteria:
- History of malignancy or active malignant disease at the time of the index procedure.
- Prior coronary artery bypass grafting (CABG) or prior percutaneous coronary intervention (PCI) performed in non-LAD coronary arteries.
- Presentation with ST-segment elevation myocardial infarction (STEMI).
- Discontinuation of prescribed medical therapy by patient preference within one year after the index procedure.
- Presence of multiple chronic total occlusions (CTOs) involving more than one coronary artery.
- Significant side branch disease of the LAD requiring two bypass grafts.
- Performance of crossover stenting from the LAD into the left main coronary artery during LAD CTO-PCI.
- Treatment of LAD CTO with drug-eluting balloon (DEB) angioplasty without stent implantation.
- Left ventricular ejection fraction (LVEF) less than 30%.
- Presence of severe valvular heart disease (e.g., severe aortic or mitral stenosis or regurgitation).
- Incomplete angiographic or clinical follow-up data.
- Use of mechanical circulatory support devices due to advanced heart failure, including intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), or left ventricular assist device (LVAD).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Coronary Artery Bypass Grafting (CABG)
Patients with isolated chronic total occlusion of the left anterior descending artery who underwent coronary artery bypass graft surgery.
|
Coronary artery bypass graft surgery performed as part of routine clinical care prior to study inclusion.
|
|
Percutaneous Coronary Intervention (PCI)
Patients with isolated chronic total occlusion of the left anterior descending artery who underwent percutaneous coronary intervention.
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Percutaneous coronary intervention performed as part of routine clinical care prior to study inclusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedural success
Time Frame: perioperatively / periprocedurally
|
Successful completion of coronary revascularization of the left anterior descending artery without in-hospital major adverse cardiac events.
|
perioperatively / periprocedurally
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Major adverse cardiac events (MACCE) at 3 years
Time Frame: 3 years
|
Composite endpoint including all-cause mortality, non-fatal myocardial infarction, cerebrovascular events, and target vessel revascularization within 3 years after the index procedure.
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sefa SURAL, MD, Toros University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Surgical Procedures, Operative
- Endovascular Procedures
- Vascular Surgical Procedures
- Cardiovascular Surgical Procedures
- Minimally Invasive Surgical Procedures
- Vascular Grafting
- Myocardial Revascularization
- Cardiac Surgical Procedures
- Thoracic Surgical Procedures
- Percutaneous Coronary Intervention
- Coronary Artery Bypass
Other Study ID Numbers
- MLP-SSURAL-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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