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Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion

N

Nanjing Medical University

Status

Enrolling

Conditions

Coronary Atheroscleroses

Treatments

Drug: OMT
Procedure: PCI

Study type

Observational

Funder types

Other

Identifiers

NCT06542653
CTO-PCI

Details and patient eligibility

About

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.

Full 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.

Enrollment

258 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

258 participants in 2 patient groups

CTO-PCI group
Description:
successful percutaneous coronary intervention (PCI)
Treatment:
Procedure: PCI
Drug: OMT
CTO-OMT group
Description:
optimal medical therapy (OMT)
Treatment:
Drug: OMT

Trial contacts and locations

1

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Central trial contact

Mei Wang; Lei Jiang

Data sourced from clinicaltrials.gov

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