Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients
NCT ID: NCT05923489
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2618 participants
INTERVENTIONAL
2023-10-26
2029-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Routine Angiography Follow-up (RAF) group
Patients in the RAF group will have routine angiography follow-up at 12 months after revascularization.
Routine Angiography Follow-up
Patients in the RAF group will have routine angiography follow-up at 12 months after revascularization.
Routine Clinical Follow-up (RCF) group
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.
Routine Clinical Follow-up
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.
Interventions
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Routine Angiography Follow-up
Patients in the RAF group will have routine angiography follow-up at 12 months after revascularization.
Routine Clinical Follow-up
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Jinhua Central Hospital
OTHER
Changxing People's Hospital
OTHER
The Affiliated Hospital of Hangzhou Normal University
OTHER
Second Affiliated Hospital of Shantou University Medical College
OTHER
Dongyang People's Hospital
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
Huizhou Municipal Central Hospital
OTHER
First Affiliated Hospital of Ningbo University
NETWORK
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Locations
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The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Jun Jiang
Role: primary
Other Identifiers
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2023-0332
Identifier Type: -
Identifier Source: org_study_id