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

NCT ID: NCT05923489

Last Updated: 2023-12-07

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2618 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-26

Study Completion Date

2029-10-15

Brief Summary

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

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

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.

Group Type EXPERIMENTAL

Routine Angiography Follow-up

Intervention Type DIAGNOSTIC_TEST

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.

Group Type ACTIVE_COMPARATOR

Routine Clinical Follow-up

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinhua Central Hospital

OTHER

Sponsor Role collaborator

Changxing People's Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Hangzhou Normal University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Shantou University Medical College

OTHER

Sponsor Role collaborator

Dongyang People's Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Huizhou Municipal Central Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Ningbo University

NETWORK

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Jiang, MD, PhD

Role: CONTACT

Phone: +86 0571 87784808

Email: [email protected]

Jinlong Zhang, MD, PhD

Role: CONTACT

Phone: +86 15757197513

Email: [email protected]

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