NCT05923489

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,618

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
42mo left

Started Oct 2023

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Oct 2023Oct 2029

First Submitted

Initial submission to the registry

June 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 26, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2029

Last Updated

December 7, 2023

Status Verified

October 1, 2023

Enrollment Period

3 years

First QC Date

June 20, 2023

Last Update Submit

November 30, 2023

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina

    The rate of a composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina

    24 months

Secondary Outcomes (10)

  • Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina

    60 months

  • All-cause death

    24 and 60 months

  • Myocardial infarction

    24 and 60 months

  • Hospitalization for unstable angina

    24 and 60 months

  • Cardiac death

    24 and 60 months

  • +5 more secondary outcomes

Study Arms (2)

Routine Angiography Follow-up (RAF) group

EXPERIMENTAL

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

Diagnostic Test: Routine Angiography Follow-up

Routine Clinical Follow-up (RCF) group

ACTIVE COMPARATOR

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.

Diagnostic Test: Routine Clinical Follow-up

Interventions

Routine Angiography Follow-upDIAGNOSTIC_TEST

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

Routine Angiography Follow-up (RAF) group
Routine Clinical Follow-upDIAGNOSTIC_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.

Routine Clinical Follow-up (RCF) group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Jun Jiang, MD, PhD

CONTACT

+86 0571 87784808jiang-jun@zju.edu.cn

Jinlong Zhang, MD, PhD

CONTACT

+86 15757197513jinlong1102@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2023

First Posted

June 28, 2023

Study Start

October 26, 2023

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 15, 2029

Last Updated

December 7, 2023

Record last verified: 2023-10

Locations

CN(1)