Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

(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.

Trial population

Patients were referred for PCI based on CTO-related symptoms or evidence of viability, or corresponding ischemia in the area of the CTO artery. The enrolled patients were divided into 2 groups, i.e., CTO-PCI group (n=187) and CTO-OMT group (n=46). The strategy to perform PCI on CTO patients was dependent on some factors, including co-morbidity, technical challenges, operators' preference

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • PCI

    Procedure/Surgery

    successful percutaneous coronary intervention (PCI) in Coronary chronic total occlusions (CTOs) patients

  • OMT

    Drug

    optimal medical therapy (OMT) in CTO patients, such as aspirin 1td, ACEI/ARB 1td, β blocker 1td, statin 1td.

Treatment groups

258 Participants
are divided into 2 treatment groups
Group A: CTO-PCI group2 interventions
Group B: CTO-OMT group1 intervention

Trial outcomes

Primary outcomes

1

major adverse cardiac cerebrovascular events (MACCE)

including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke.

Time frame
January 2011 to December 2023

Secondary outcomes

1

all-cause death

all-cause death

Time frame
January 2011 to December 2023

Other outcomes

Sponsors and contacts

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