Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion

Recruiting

• Conditions: Coronary Atheroscleroses
• Interventions: Procedure: PCI; Drug: OMT

• Registration Number: NCT06542653
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

Coronary chronic total occlusions (CTOs) are considered to increase the risk of adverse clinical outcomes. The purpose of this study was to evaluate whether long-term clinical outcomes could be improved by successful percutaneous coronary intervention (PCI) over optimal medical therapy (OMT) in CTO patients.

Detailed Description

patients with CTO lesions undergoing PCI at the First Affiliated Hospital of Nanjing Medical University from January 2011 to December 2017 were enrolled. After someone were excluded due to CABG surgery, patients who met the enrollment criteria were divided into successful CTO-PCI group and CTO-OMT group based on the treatment received. The study primary endpoint was major adverse cardiac cerebrovascular events (MACCE), including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke. The secondary endpoint was all-cause death.

Study Timeline

• Study Start: 2023-09-17
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-03
• Study First Posted: 2024-08-07
• Primary Completion: 2024-09-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Study Completion: 2025-09-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

• patients with at least one coronary CTO lesion at our hospital in between January 2011 and December 2017

Exclusion Criteria

• (1) patients with ST-segment elevation myocardial infarction (STEMI)
• (2)a history of coronary artery bypass grafting (CABG)
• (3) cardiogenic shock
• (4) malignant tumor. Patients were referred for PCI based on CTO-related symptoms or evidence of viability, or corresponding ischemia in the area of the CTO artery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CTO-PCI group	PCI	successful percutaneous coronary intervention (PCI)
CTO-PCI group	OMT	successful percutaneous coronary intervention (PCI)
CTO-OMT group	OMT	optimal medical therapy (OMT)

Primary Outcome Measures

Name	Time	Method
major adverse cardiac cerebrovascular events (MACCE)	January 2011 to December 2023	including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke.

Secondary Outcome Measures

Name	Time	Method
all-cause death	January 2011 to December 2023	all-cause death

Trial Locations

Locations (1)

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China