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Recruiting NCT06542653

Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion

Observational Coronary Atheroscleroses

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PCI, OMT.
Who it may be relevant to
Registry conditions: Coronary Atheroscleroses. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure PCI
    successful percutaneous coronary intervention (PCI) in Coronary chronic total occlusions (CTOs) patients
  • Drug OMT
    optimal medical therapy (OMT) in CTO patients, such as aspirin 1td, ACEI/ARB 1td, β blocker 1td, statin 1td.

Primary outcome measures

  • major adverse cardiac cerebrovascular events (MACCE) [Time frame: January 2011 to December 2023]
Secondary outcome measures (1)
  • all-cause death [Time frame: January 2011 to December 2023]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 1 center
  • The First Affiliated Hospital with Nanjing Medical University — Nanjing

Identifiers

NCT: NCT06542653 · CTO-PCI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗