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Effects of Different Revascularization StrateGies in Complex Coronary Artery DiseasE (EDGE)

Effects of Different Revascularization Strategies on Cardiovascular Outcomes in Patients With Complex Coronary Artery Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05121610
Enrollment
2864
Registered
2021-11-16
Start date
2021-12-01
Completion date
2023-09-01
Last updated
2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

PCI, CABG, HCR, Complex coronary artery disease

Brief summary

Coronary heart disease is one of the most serious diseases that endanger people's health. Complex coronary artery disease is critical and has high mortality. Therefore, it is urgent to explore the best treatment method for complex coronary artery disease. Some previous studies have shown that patients with left main coronary artery disease with a SYNTAX score\> 32 points, and diabetic/non-diabetic three-vessel disease patients with coronary heart disease with a SYNTAX score \> 22 points, CABG is recommended for revascularization. However, with the continuous innovation of surgical technology and the rapid development of surgical instruments, the treatment of patients with complex coronary artery disease is increasing. Therefore, it is necessary to investigate the effects of different revascularization strategies on long-term prognosis in patients with complex coronary artery disease (SYNTAX score \> 22 points).

Interventions

PROCEDUREThe procedures include PCI, CABG and HCR

The procedures include PCI, CABG and HCR

Sponsors

Beijing Anzhen Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Male/female aged 18-80 years; 2. Having complex coronary artery disease (SYNTAX score \> 22 points) undergoing myocardial revascularization

Exclusion criteria

1. Cardiogenic shock or hemodynamic instability; 2. Undergoing other heart surgery at the same time; 3. Previous coronary artery bypass surgery; 4. History of cerebral hemorrhage; 5. Ischemic stroke in the past six months; 6. History of cancer; 7. Life expectancy no more than 12 months

Design outcomes

Primary

MeasureTime frameDescription
MACCE1 yearMajor adverse cardiovascular and cerebrovascular events (MACCE) at 1 year, including all-cause death, non-fatal myocardial infarction, ischemia-driven revascularization, and non-fatal stroke

Secondary

MeasureTime frameDescription
Cardiovascular death1 yearCardiovascular death
Non-fatal myocardial infarction1 yearNon-fatal myocardial infarction
Ischemia-driven revascularization1 yearIschemia-driven revascularization
Non-fatal stroke1 yearStroke is defined as a neurological deficit with symptoms or signs that last at least 24 hours and imaging studies (CT or MRI) confirm the presence of cerebral infarction or cerebral hemorrhage.
All cause death1 yearAll-cause death is defined as death from cardiovascular causes, death from non-cardiovascular causes, and death from unknown causes.
The composite endpoints including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke1 yearThe composite endpoints including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke
The composite endpoints including cardiovascular death or nonfatal myocardial infarction1 yearThe composite endpoints including cardiovascular death or nonfatal myocardial infarction
All bleeding events defined by the BARC bleeding criteria1 yearAll bleeding events defined by the BARC bleeding criteria
Type 2, 3 and 5 bleeding events defined by the BARC bleeding criteria1 yearType 2, 3 and 5 bleeding events defined by the BARC bleeding criteria
The composite endpoints including all-cause death, non-fatal myocardial infarction, and ischemia-driven revascularization1 yearThe composite endpoints including all-cause death, non-fatal myocardial infarction, and ischemia-driven revascularization

Contacts

Primary ContactMiao Yu, Doctor
evelynym@hotmail.com13811879285

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026