Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients

Zhejiang University

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Diagnostic Test: Routine Clinical Follow-up; Diagnostic Test: Routine Angiography Follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT05923489

2023-0332

Details and patient eligibility

About

Comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention in high-risk patients.

Enrollment: 2,618 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• Successful PCI with at least two of the following high-risk factors:

A. Left main lesion; B. Bifurcation lesion (true bifurcation); C. Ostial lesion of main vessels (left anterior descending, left circumflex artery, right coronary artery); D. Chronic total occlusion; E. Multivessel revascularization (≥ 2 vessels); F. In-stent restenosis; G. Diffuse long lesion (lesion length ≥ 30 mm or stent length ≥ 38 mm); H. Severe calcified lesion (Significant severe calcification on angiography); I. Bypass graft lesion; J. Diabetes mellitus; K. Chronic kidney disease (defined as an estimated glomerular filtration rate of <30 ml per minute per 1.73 m2 of body-surface area or the receipt of dialysis); L. Myocardial infarction;

• He/she or his/her legally authorized representative provides written informed

Exclusion criteria

• Revascularization with bare metal stents and/or balloon angioplasty with non-drug-coated balloons.
• Pregnant and/or lactating women.
• Life expectancy of less than 2 years.
• Repeat interventional therapy is planned.
• Subject was unable to provide written informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,618 participants in 2 patient groups

Routine Angiography Follow-up (RAF) group

Experimental group

Description:

Patients in the RAF group will have routine angiography follow-up at 12 months after revascularization.

Treatment:

Diagnostic Test: Routine Angiography Follow-up

Routine Clinical Follow-up (RCF) group

Active Comparator group

Description:

Patients in the RCF group will have routine clinical follow-up at 12 months after revascularization, and the physician will decide whether further invasive testing is needed.

Treatment:

Diagnostic Test: Routine Clinical Follow-up