Coronary Artery DiseaseNCT05611190
CT-FFR-guided Strategy for In-stent Restenosis
A study testing CT-FFR in people with Coronary Artery Disease and In-stent Restenosis, run by Yan'an Affiliated Hospital of Kunming Medical University.
Trial summary
This study will be a prospective, randomized clinical trial to compare standard practice guided by usual care testing to CT-FFR-guided management in patients with in-stent restenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, In-stent Restenosis
- What is being tested?
- CT-FFR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- No sites listed yet
- Study dates
- 12 Dec 2022to 11 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- (1) >18 years old;
- (2) ability to provide informed consent;
- (3) previous PCI who underwent CCTA and have at least 1 lesion with a percent diameter in-stent stenosis between 30% and 90% in a coronary artery with a ≥2.25 mm reference vessel diameter by visual assessment;
- (4) accepted further clinically indicated coronary testing, coronary arteriography, or FFR, or IVUS, or PCI, etc.
Who cannot join
- (1) Prior coronary artery bypass surgery (CABG), heart valve surgery, cardiac pacemaker, or implanted cardiac defibrillator;
- (2) Target vascular stents were evaluated for implantation within one month;
- (3) unstable clinical conditions including acute chest pain, cardiogenic shock, congestive heart failure (NYHA grade III or IV), unstable blood pressure (systolic blood pressure < 90mmHg) or acute pulmonary edema;
- (4) Acute myocardial infarction occurred within 7 days before enrollment, and left ventricular ejection fraction ≤40%;
- (5) Other severe cases are not suitable for clinical trials including complex congenital heart disease, sick sinus syndrome, long QT syndrome, severe arrhythmia, tachycardia, severe asthma, severe or very severe chronic obstructive pulmonary disease (COPD) and severe chronic renal damage;
- (6) Contraindication to beta blockers, nitroglycerin, adenosine, or allergy to iodine contrast agents;
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- (7) Pregnancy or pregnancy status unknown;
- (8) Life expectancy <1 years;
- (9)Repeated enrollment;
- (10) Any other factors that other researchers consider not suitable for inclusion or completion of this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Coronary CT Angiography-Derived Fractional Flow Reserve-guided Optimize Treatment Strategy for In-stent Restenosis
This study will be a prospective, randomized clinical trial to compare standard practice guided by usual care testing to CT-FFR-guided management in patients with in-stent restenosis.
Read the detailed description
This trial will randomize 294 patients with in-stent restenosis to receive either CT-FFR or routine clinical assessment. In all subjects, the investigators will review all diagnostic test results and determine a treatment strategy. The primary end point will be 12-month Major Adverse Coronary Event (MACE) rates, defined as all cause death, non-fatal myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR). Secondary end points will include total medical costs, and quality of life (QOL), medical radiation exposure, etc. We will test noninferiority of current FFR-guided strategy compared with standard care strategy.
- Conditions
- Coronary Artery Disease, In-stent Restenosis
- Being tested
- CT-FFR, Usual Care
- Keywords
- Coronary CT Angiography-derived Fractional Flow Reserve, In-stent Restenosis, Major Adverse Coronary Events
- 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.
CT-FFRDiagnostic test
CT-FFR is a type of non-invasive procedure to provide a 3D model of coronary arteries as a way to evaluate the hemodynamic significance of coronary artery lesions. CT-FFR calculates FFR from subject-specific CCTA data using computational fluid dynamics technology. CT-FFR value ≤0.80 is considered hemodynamically significant.
Usual CareDiagnostic test
Participants randomized to usual care will be evaluated according to institutional standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Other | Participants randomized to usual care will be evaluated according to institutional standard practice. The investigators will review clinical data and results of the diagnostic tests to recommend a treatment strategy, according to the institution's standard practice. Receives: Diagnostic Test: Usual Care |
| CT-FFR | Experimental | Participants randomized to a CT-FFR strategy will be assigned to non-invasive CT-FFR evaluation. The investigators will review the results CT-FFR, and will recommend a further ICA test if CT-FFR≤0.8. The investigators will review the results of all available diagnostic tests, including CT-FFR and ICA, and will recommend a treatment strategy accordingly. Receives: Diagnostic Test: CT-FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month MACE
12-month Major Adverse Coronary Event (MACE) rates, defined as:
- All cause death
- Non-fatal myocardial infarction (MI)
- Ischemia-driven target vessel revascularization (TVR)
Measured: 12 months
Secondary outcomes (6)
MACE
MACE defined as:
- All cause death
- Non-fatal MI
- Clinical-driven TVR
Measured: 3-month, 6-month, 24-month, 36-month
Rates of Target lesion failure (TLF)
Composite of clinically driven TLR, MI or cardiac death related to the target vessel.
Measured: 3-month, 6-month, 24-month, 36-month
Total costs
Total costs will be calculated from the use of all cardiac-related invasive and non-invasive tests, revascularization procedures, hospital admissions and outpatient attendances due to a cardiovascular cause, and cardiac medications.
Measured: 6-month, 12-month
Quality of life (QOL) will be assessed using the EQ-5D-VAS questionnaire
Quality of life (QOL), will be assessed using the EQ-5D-VAS questionnaire
Measured: 6-month, 12-month
Seattle Angina Questionnaire
angina status, will be assessed using the Seattle Angina Questionnaire
Measured: 6-month, 12-month
Cumulative radiation exposure
Cumulative radiation exposure within 6-month and 12-month of study entry included all cardiovascular tests and invasive procedures, including CTA, myocardial perfusion imaging, and ICA.
Measured: 6-month, 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start12 Dec 2022 (estimated)
- Primary completion11 Dec 2024 (estimated)
- Study completion11 Dec 2025 (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.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan'an Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang Xue, Principal investigator, Yan'an Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611190
- Sponsor's protocol ID
- In-stent Restenosis
- Status last verified
- Nov 2022
- First submitted
- 3 Nov 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary CT Angiography-Derived Fractional Flow Reserve-guided Optimize Treatment Strategy for In-stent Restenosis
- ClinicalTrials.gov ID
- NCT05611190
- Acronym / sponsor ID
- In-stent Restenosis
- Conditions
- Coronary Artery Disease, In-stent Restenosis
- Keywords
- Coronary CT Angiography-derived Fractional Flow Reserve, In-stent Restenosis, Major Adverse Coronary Events
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Yan'an Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 12 Dec 2022 (estimated)
- Primary completion
- 11 Dec 2024 (estimated)
- Study completion
- 11 Dec 2025 (estimated)
- First posted
- 9 Nov 2022 (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.
This study will be a prospective, randomized clinical trial to compare standard practice guided by usual care testing to CT-FFR-guided management in patients with in-stent restenosis.
Detailed description
This trial will randomize 294 patients with in-stent restenosis to receive either CT-FFR or routine clinical assessment. In all subjects, the investigators will review all diagnostic test results and determine a treatment strategy. The primary end point will be 12-month Major Adverse Coronary Event (MACE) rates, defined as all cause death, non-fatal myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR). Secondary end points will include total medical costs, and quality of life (QOL), medical radiation exposure, etc. We will test noninferiority of current FFR-guided strategy compared with standard care strategy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Other | Diagnostic Test: Usual CareParticipants randomized to usual care will be evaluated according to institutional standard practice. The investigators will review clinical data and results of the diagnostic tests to recommend a treatment strategy, according to the institution's standard practice. |
| CT-FFR | Experimental | Diagnostic Test: CT-FFRParticipants randomized to a CT-FFR strategy will be assigned to non-invasive CT-FFR evaluation. The investigators will review the results CT-FFR, and will recommend a further ICA test if CT-FFR≤0.8. The investigators will review the results of all available diagnostic tests, including CT-FFR and ICA, and will recommend a treatment strategy accordingly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (1) >18 years old;
- (2) ability to provide informed consent;
- (3) previous PCI who underwent CCTA and have at least 1 lesion with a percent diameter in-stent stenosis between 30% and 90% in a coronary artery with a ≥2.25 mm reference vessel diameter by visual assessment;
- (4) accepted further clinically indicated coronary testing, coronary arteriography, or FFR, or IVUS, or PCI, etc.
Key exclusion criteria (10 listed)
- (1) Prior coronary artery bypass surgery (CABG), heart valve surgery, cardiac pacemaker, or implanted cardiac defibrillator;
- (2) Target vascular stents were evaluated for implantation within one month;
- (3) unstable clinical conditions including acute chest pain, cardiogenic shock, congestive heart failure (NYHA grade III or IV), unstable blood pressure (systolic blood pressure < 90mmHg) or acute pulmonary edema;
- (4) Acute myocardial infarction occurred within 7 days before enrollment, and left ventricular ejection fraction ≤40%;
- (5) Other severe cases are not suitable for clinical trials including complex congenital heart disease, sick sinus syndrome, long QT syndrome, severe arrhythmia, tachycardia, severe asthma, severe or very severe chronic obstructive pulmonary disease (COPD) and severe chronic renal damage;
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 |
|---|---|---|
| CT-FFRCT-FFR is a type of non-invasive procedure to provide a 3D model of coronary arteries as a way to evaluate the hemodynamic significance of coronary artery lesions. CT-FFR calculates FFR from subject-specific CCTA data using computational fluid dynamics technology. CT-FFR value ≤0.80 is considered hemodynamically significant. | Diagnostic test | CT-FFR |
| Usual CareParticipants randomized to usual care will be evaluated according to institutional standard practice. | Diagnostic test | Usual Care |
Primary outcome
12-month MACE
Time frame: 12 months
12-month Major Adverse Coronary Event (MACE) rates, defined as: 1. All cause death 2. Non-fatal myocardial infarction (MI) 3. Ischemia-driven target vessel revascularization (TVR)
6 secondary outcomes
MACE
Time frame: 3-month, 6-month, 24-month, 36-month
Rates of Target lesion failure (TLF)
Time frame: 3-month, 6-month, 24-month, 36-month
Total costs
Time frame: 6-month, 12-month
Quality of life (QOL) will be assessed using the EQ-5D-VAS questionnaire
Time frame: 6-month, 12-month
Seattle Angina Questionnaire
Time frame: 6-month, 12-month
Cumulative radiation exposure
Time frame: 6-month, 12-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Qiang Xue principal investigator
Yan'an Affiliated Hospital of Kunming Medical University
Questions about this trial
What is this clinical trial studying?
A study testing CT-FFR in people with Coronary Artery Disease and In-stent Restenosis, run by Yan'an Affiliated Hospital of Kunming Medical University.
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 10 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: status not confirmed, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiang Xue (13987199913, Xueqiang3513@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month MACE (time frame: 12 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 9 Nov 2022.