Coronary Artery DiseaseNCT05923489
Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients
A study testing Routine Angiography Follow-up and Routine Clinical Follow-up in people with Coronary Artery Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention in high-risk patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Routine Angiography Follow-up and Routine Clinical Follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,618 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2023to 15 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Successful PCI with at least two of the following high-risk factors:
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jun Jiang
About this study
Official title: Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients (The REVISE Trial)
Comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention in high-risk patients.
- Conditions
- Coronary Artery Disease
- Being tested
- Routine Angiography Follow-up, Routine Clinical Follow-up
- Keywords
- percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Angiography Follow-upDiagnostic test
Patients in the RAF group will have routine angiography follow-up at 12±3 months after revascularization.
Routine Clinical Follow-upDiagnostic test
Patients in the RCF group will have routine clinical follow-up at 12±3 months after revascularization, and the further interventions can be performed at the discretion of the physician according to the current standard.
| Study group | Role | What they receive |
|---|---|---|
| Routine Angiography Follow-up (RAF) group | Experimental | Patients in the RAF group will have routine angiography follow-up at 12±3 months after revascularization. Receives: 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±3 months after revascularization, and the further interventions can be performed at the discretion of the physician according to the current standard. Receives: Diagnostic Test: Routine Clinical Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (9)
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
Measured: 60 months
All-cause death
The rate of all-cause death
Measured: 24 and 60 months
Myocardial infarction
The rate of myocardial infarction
Measured: 24 and 60 months
Hospitalization for unstable angina
The rate of hospitalization for unstable angina
Measured: 24 and 60 months
Cardiac death
The rate of hospitalization for cardiac death
Measured: 24 and 60 months
Invasive angiography during follow-up
The rate of invasive angiography during follow-up
Measured: 24 and 60 months
Any revascularization
The rate of any revascularization during follow-up (ischemia-driven vs. all-cause)
Measured: 24 and 60 months
Revascularization of any target vessel/lesion
The rate of revascularization of any target vessel/lesion
Measured: 24 and 60 months
Revascularization of any non-target vessel/lesion
The rate of revascularization of any non-target vessel/lesion
Measured: 24 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start26 Oct 2023
- Primary completion30 Dec 2028 (estimated)
- Study completion15 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,618 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jinhua Central Hospital, Changxing People's Hospital, The Affiliated Hospital of Hangzhou Normal University, Second Affiliated Hospital of Shantou University Medical College, Dongyang People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Huzhou Central Hospital, First Affiliated Hospital of Ningbo University, The First People's Hospital of Linping District, The Sixth People's Hospital of Xinjiang Uygur Autonomous Region, Ningbo Medical Center Lihuili Hospital, The Eighth People's Hospital of JiNan, The First Affiliated Hospital of Nanchang University, Ruian People's Hospital of Zhejiang Province, Shaoxing Central Hospital, The Second People's Hospital of Quzhou
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923489
- Sponsor's protocol ID
- 2023-0332
- Status last verified
- Aug 2026
- First submitted
- 20 Jun 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients (The REVISE Trial)
- ClinicalTrials.gov ID
- NCT05923489
- Acronym / sponsor ID
- 2023-0332
- Conditions
- Coronary Artery Disease
- Keywords
- percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,618 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Jinhua Central Hospital, Changxing People's Hospital, The Affiliated Hospital of Hangzhou Normal University, Second Affiliated Hospital of Shantou University Medical College, Dongyang People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Huzhou Central Hospital, First Affiliated Hospital of Ningbo University, The First People's Hospital of Linping District, The Sixth People's Hospital of Xinjiang Uygur Autonomous Region, Ningbo Medical Center Lihuili Hospital, The Eighth People's Hospital of JiNan, The First Affiliated Hospital of Nanchang University, Ruian People's Hospital of Zhejiang Province, Shaoxing Central Hospital, The Second People's Hospital of Quzhou
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 15 Oct 2029 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention in high-risk patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Angiography Follow-up (RAF) group | Experimental | Diagnostic Test: Routine Angiography Follow-upPatients in the RAF group will have routine angiography follow-up at 12±3 months after revascularization. |
| Routine Clinical Follow-up (RCF) group | Active comparator | Diagnostic Test: Routine Clinical Follow-upPatients in the RCF group will have routine clinical follow-up at 12±3 months after revascularization, and the further interventions can be performed at the discretion of the physician according to the current standard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Successful PCI with at least two of the following high-risk factors:
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Angiography Follow-upPatients in the RAF group will have routine angiography follow-up at 12±3 months after revascularization. | Diagnostic test | Routine Angiography Follow-up (RAF) group |
| Routine Clinical Follow-upPatients in the RCF group will have routine clinical follow-up at 12±3 months after revascularization, and the further interventions can be performed at the discretion of the physician according to the current standard. | Diagnostic test | Routine Clinical Follow-up (RCF) group |
Primary outcome
Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina
Time frame: 24 months
The rate of a composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina
9 secondary outcomes
Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina
Time frame: 60 months
All-cause death
Time frame: 24 and 60 months
Myocardial infarction
Time frame: 24 and 60 months
Hospitalization for unstable angina
Time frame: 24 and 60 months
Cardiac death
Time frame: 24 and 60 months
Invasive angiography during follow-up
Time frame: 24 and 60 months
Any revascularization
Time frame: 24 and 60 months
Revascularization of any target vessel/lesion
Time frame: 24 and 60 months
Revascularization of any non-target vessel/lesion
Time frame: 24 and 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Angiography Follow-up and Routine Clinical Follow-up in people with Coronary Artery Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Jiang, MD, PhD (+86 0571 87784808, jiang-jun@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.