Non ST Segment Elevation Acute Coronary SyndromeNCT05202041
Non-IRA Functional Evaluation With AccuFFRangio in NSTE-ACS
A study testing AccuFFRangio-guided strategy and Angiography-guided strategy in people with Non ST Segment Elevation Acute Coronary Syndrome and Coronary Artery Disease, run by Wuhan Asia Heart Hospital.
Trial summary
This is a prospective, single-center clinical trial. AccuFFRangio (ArteryFlow Technology Co., Ltd., Hangzhou, China) is a novel method for evaluating the functional significance of coronary stenosis by computing the pressure in the vessel based on angiographic images. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non ST Segment Elevation Acute Coronary Syndrome, Coronary Artery Disease, Percutaneous Coronary Intervention
- What is being tested?
- AccuFFRangio-guided strategy and Angiography-guided strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2022to 30 Mar 2023
- 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
- 18 Years and older
- Non-ST-segment elevation acute coronary syndrome patients with at least 1 non-IRA
- Diameter stenosis of 50%-90% by visual estimate
- Reference vessel size > 2 mm in stenotic segment by visual estimate
Who cannot join
- LVEF ≤ 40%
- eGFR < 60 mL/min
- Allergy to contrast media, adenosine
- Prior CABG
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic Performance and Prognostic Ability of AccuFFRangio for Non-IRA in NSTE-ACS Patients
This is a prospective, single-center clinical trial. AccuFFRangio (ArteryFlow Technology Co., Ltd., Hangzhou, China) is a novel method for evaluating the functional significance of coronary stenosis by computing the pressure in the vessel based on angiographic images. The purpose of this study is to investigate the diagnostic performance and prognostic ability of AccuFFRangio for non-IRA in NSTE-ACS patients.
- Conditions
- Non ST Segment Elevation Acute Coronary Syndrome, Coronary Artery Disease, Percutaneous Coronary Intervention
- Being tested
- AccuFFRangio-guided strategy, Angiography-guided strategy
- 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.
AccuFFRangio-guided strategyOther
In this study, the AccuFFRangio-guided strategy will be applied to in the AccuFFRangio group in which calculation of the AccuFFRangio values of all target coronary arteries with lesions with diameter stenosis of ≥ 50% (visual estimation) and with suitability to PCI revascularization will be carried out. If AccuFFRangio ≤ 0.80, then simultaneous PCI revascularization of target blood vessels will be carried out. If AccuFFRangio > 0.80, then no PCI revascularization of target blood vessels will be carried out.
Angiography-guided strategyOther
In this study, CAG-guided strategy will be used for the control group, i.e., in accordance with current guideline recommendations, all target coronary arteries with lesions with diameter stenosis of ≥ 70% (visual estimation) and suited for PCI revascularization will undergo PCI revascularization.
| Study group | Role | What they receive |
|---|---|---|
| AccuFFRangio Group | Experimental | NSTE-ACS patients with multiple lesions who met the requirements of the study were enrolled and received coronary angiography. First, the revascularization of the criminal vessel (PCI) was completed. The patients were randomly grouped and divided into AccuFFRangio Group and Angiography Group if the treatment results were good. The AccuFFRangio Group was defined as non-IRA of these patients who were treated with PCI after angio-FFR measurement with FFR≤0.8. Receives: Other: AccuFFRangio-guided strategy |
| Angiography Group | Active comparator | The Angiography Group was defined as PCI treatment for non-IRA when diameter stenosis > 70% based on angiographic results. Receives: Other: Angiography-guided strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vessel-oriented composite endpoints (VOCEs)
Composite of vessel-related cardiovascular death, vessel-related myocardial infarction, and ischemia-driven target vessel revascularization.
Measured: 1 year
Post-PCI AccuFFRangio
AccuFFRangio limits to yield no VOCEs.
Measured: 1 year
Secondary outcomes (1)
Cost analysis
Cost savings of AccuFFRangio-guided strategy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start15 Feb 2022 (estimated)
- Primary completion14 Feb 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non ST Segment Elevation Acute Coronary SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Asia Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Song, MD, Study chair, Wuhan Aisa Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202041
- Sponsor's protocol ID
- AFCA20211130
- Status last verified
- Jan 2022
- First submitted
- 7 Jan 2022
- Last updated
- 9 Feb 2022
- Results posted
- 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 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance and Prognostic Ability of AccuFFRangio for Non-IRA in NSTE-ACS Patients
- ClinicalTrials.gov ID
- NCT05202041
- Acronym / sponsor ID
- AFCA20211130
- Conditions
- Non ST Segment Elevation Acute Coronary Syndrome, Coronary Artery Disease, Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wuhan Asia Heart HospitalUniversity, hospital or other
- Study start
- 15 Feb 2022 (estimated)
- Primary completion
- 14 Feb 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 21 Jan 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 is a prospective, single-center clinical trial. AccuFFRangio (ArteryFlow Technology Co., Ltd., Hangzhou, China) is a novel method for evaluating the functional significance of coronary stenosis by computing the pressure in the vessel based on angiographic images. The purpose of this study is to investigate the diagnostic performance and prognostic ability of AccuFFRangio for non-IRA in NSTE-ACS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AccuFFRangio Group | Experimental | Other: AccuFFRangio-guided strategyNSTE-ACS patients with multiple lesions who met the requirements of the study were enrolled and received coronary angiography. First, the revascularization of the criminal vessel (PCI) was completed. The patients were randomly grouped and divided into AccuFFRangio Group and Angiography Group if the treatment results were good. The AccuFFRangio Group was defined as non-IRA of these patients who were treated with PCI after angio-FFR measurement with FFR≤0.8. |
| Angiography Group | Active comparator | Other: Angiography-guided strategyThe Angiography Group was defined as PCI treatment for non-IRA when diameter stenosis > 70% based on angiographic results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 Years and older
- Non-ST-segment elevation acute coronary syndrome patients with at least 1 non-IRA
- Diameter stenosis of 50%-90% by visual estimate
- Reference vessel size > 2 mm in stenotic segment by visual estimate
Key exclusion criteria (4 listed)
- LVEF ≤ 40%
- eGFR < 60 mL/min
- Allergy to contrast media, adenosine
- Prior CABG
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 |
|---|---|---|
| AccuFFRangio-guided strategyIn this study, the AccuFFRangio-guided strategy will be applied to in the AccuFFRangio group in which calculation of the AccuFFRangio values of all target coronary arteries with lesions with diameter stenosis of ≥ 50% (visual estimation) and with suitability to PCI revascularization will be carried out. If AccuFFRangio ≤ 0.80, then simultaneous PCI revascularization of target blood vessels will be carried out. If AccuFFRangio > 0.80, then no PCI revascularization of target blood vessels will be carried out. | Other | AccuFFRangio Group |
| Angiography-guided strategyIn this study, CAG-guided strategy will be used for the control group, i.e., in accordance with current guideline recommendations, all target coronary arteries with lesions with diameter stenosis of ≥ 70% (visual estimation) and suited for PCI revascularization will undergo PCI revascularization. | Other | Angiography Group |
Primary outcome
Vessel-oriented composite endpoints (VOCEs)
Time frame: 1 year
Composite of vessel-related cardiovascular death, vessel-related myocardial infarction, and ischemia-driven target vessel revascularization.
Post-PCI AccuFFRangio
Time frame: 1 year
AccuFFRangio limits to yield no VOCEs.
1 secondary outcome
Cost analysis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 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.
Dan Song, MD study chair
Wuhan Aisa Heart Hospital
Questions about this trial
What is this clinical trial studying?
A study testing AccuFFRangio-guided strategy and Angiography-guided strategy in people with Non ST Segment Elevation Acute Coronary Syndrome and Coronary Artery Disease, run by Wuhan Asia Heart Hospital.
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 4 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 Feb 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 Dan Song, MD (+86-027-65796888, songdan8300@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vessel-oriented composite endpoints (VOCEs) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 Feb 2022.