Coronary VesselsFLASHNCT05388357
AI Quantitative Coronary Angiography Versus Optical Coherent Tomography Guidance for Coronary Stent Implantation
A study testing Intervention Procedure: PCI in people with Coronary Vessels and Procedure PCI, run by Asan Medical Center at 13 sites in South Korea.
Trial summary
This study is to establish the primary hypothesis thatAI -QCA guided PCI is non-inferior to Optical coherence tomography-guided Percutaneous coronary intervention regarding minimal Stent area by Final OCT and Procedural MACE Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Vessels, Procedure PCI
- What is being tested?
- Intervention Procedure: PCI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 13 sitesSouth Korea
- Study dates
- 4 Oct 2022to 2 Oct 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women at least 19 years of age
- Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty.
- Subject with severe coronary artery disease undergoing PCI
- Written informed consent
Who cannot join
- Angiographic exclusion criteria 1) Left main lesion 2) Chronic total occlusion 3)Graft vascular lesion 4) Requiring two-stent techniques for coronary bifurcation lesions 5)Any lesion characteristics resulting in the expected inability to deliver OCT catheter to the lesion ( eg,tortuosity, moderate or severe vessel calcification)
- Acute or chronic renal dysfunction (Plasma creatinine 2.0mg/dL or more) except patients undergoing dialysis
- Primary coronary angioplasty in ST-elevation myocardial infarction(within 12-24 hours of symptom onset)
- Previous PCI with BVS
- LV dysfunction (LVEF) < 30%
- Hypersensitivity to DES and its components or there is a reason for prohibition (everolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers)
Show all 10Show fewer
- Patients who require surgery requiring discontinuation of antiplatelet drugs within 1 year of the procedure
- Life expectancy < 1 year for any disease
- Pregnancy or breast-feeding
- Patients unsuitable for enrollment judged by the Investigator
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
South Korea13 sites
Sejong General Hospital
Bucheon-si
Keimyung University Dongsan Medical Center
Daegu
Kyungpook National University Hospital
Daegu
GangNeung Asan Hospital
Gangneung
Seoul National University Bundang hospital
Gyeonggi-do
Soon Chun Hyang University Hospital Bucheon
Gyeonggi-do
Yougin Severance Hospital
Gyeonggi-do
Chungbuk National University Hospital
Jungbuk
Pusan National University Hospital
Pusan
Asan Medical Center
Seoul
Hanyang University Medical Center
Seoul
Korea University Anam Hospital
Seoul
Ulsan University Hospital
Ulsan
About this study
Official title: Fully Automated Quantitative Coronary Angiography Versus Optical Coherent Tomography Guidance for Coronary Stent Implantation (FLASH): Multicenter, Randomized Controlled Non-Interiority Trial
This study is to establish the primary hypothesis thatAI -QCA guided PCI is non-inferior to Optical coherence tomography-guided Percutaneous coronary intervention regarding minimal Stent area by Final OCT and Procedural MACE
Read the detailed description
- AI-QCA-assisted DES implantation After coronary angiography, AI-QCA software will be used to determine the lesion length and the reference vessel diameter in real time to determine the appropriate stent size for implantation. The procedure is performed as follows:
- Select the optimal projection angle providing the best view of the lesion.
- Provide sufficient nitroglycerin for vasodilation. If the lesion is severely stenotic, perform balloon angioplasty, followed by nitroglycerin supply.
- Perform AI-QCA to measure the length of the lesion and the inside diameter of the proximal and distal reference vessels.
- Determine the stent length and size according to the AI-QCA measurements. Select a stent that is 20% larger than the distal reference vessel diameter and that can provide coverage for both the proximal and distal reference vessels.
- Perform high-pressure balloon dilation after stent implantation, with the final balloon size being 20% larger than the distal and proximal reference vessel diameters.
- Perform a final coronary angiogram if no procedural complications are observed on the angiogram and stent expansion is confirmed.
- Perform a final OCT to measure the stent area (mm2), the primary efficacy endpoint.
- If significant suboptimal stent results, such as severe underexpansion, extensive strut malapposition, or major stent edge dissection, occur, additional procedures to correct them are permitted to ensure patient safety, although they are generally discouraged. (The primary endpoint will be assessed by OCT run before such correction.)
- OCT guided DES implantation
After coronary angiography, OCT is performed to determine the appropriate stent size for implantation. After the stent procedure, OCT is performed again to check for an area that is smaller than the area of distal reference vessel and for sufficient dilatation. If necessary, high-pressure balloon dilation is performed to minimize residual stenosis. The procedure is performed as follows:
- Select the optimal projection angle providing the best view of the lesion.
- Provide sufficient nitroglycerin for vasodilation. If the lesion is severely stenotic, perform balloon angioplasty, followed by nitroglycerin supply.
- Perform OCT to obtain pre-procedural images of the vessel. If there is a stenosis and OCT images cannot be obtained, perform OCT after adequate balloon angioplasty.
- Determine the length and size of the stent to be implanted according to the OCT images. Select the stent size in consideration of the mean lumen diameter and mean external elastic lamina (EEL) diameter of the distal reference vessel. If the EEL is not observed, use a stent that is 0.25 mm larger than the mean lumen diameter. Select the length by measuring the length of the proximal and distal reference vessel segments on the OCT.
- Perform high-pressure balloon dilation after stent implantation. Select the final balloon size by considering the inside diameters of the distal and proximal reference vessels and EEL diameter.
- Perform OCT. If no procedure-related complications are observed and there is no underexpansion or malapposition of the stent, perform a final coronary angiogram. If procedure-related complications or underexpansion or malapposition of the stent is observed, correct it, and then perform a final OCT to measure the stent area (mm2), the primary efficacy endpoint.
- Conditions
- Coronary Vessels, Procedure PCI
- Being tested
- Intervention Procedure: PCI
- Keywords
- OCT, AI ,PCI
- Medical subject headings
- Ornithine Carbamoyltransferase Deficiency Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Procedure: PCIOther
Percutaneous Coronary Intervention
| Study group | Role | What they receive |
|---|---|---|
| AI -guided PCI | Experimental | based on AI-QCA measurement, a drug eluting stent of an appropriate size is inserted and then high-pressure balloon dilatation is additionally actively performed in all patients. Receives: Other: Intervention Procedure: PCI |
| OCT-guided PCI | Active comparator | In the OCT group, the size of the stent is determined using intravascular optical coherence tomography, and balloon dilatation is additionally performed if necessary. Receives: Other: Intervention Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal Stent Area evaluated by OCT
Minimal Stent Area evaluated by OCT after stenting of the target lesion
Measured: 1hour
Procedural complications
Procedural complications including angiographic dissection, perforation, or acute closure requiring active intervention after stent implantation
Measured: 24hours
Secondary outcomes (11)
Procedural success
Stent expansion (≥ 90%) in final OCT assessment and successful stent delivery without target-lesion failure in 24 hours
Measured: 24hours
OCT endpoint
Stent expansion, stent malapposition, intra-stent tissue (plaque or thrombus) protrusion, untreated reference segment disease
Measured: 24hours
Angiographic endpoint
Minimal lumen diameter at the stented segment, diameter stenosis at the stented segment, acute gain at the stented segment
Measured: 24hours
Death
All-cause death , Cardiac and non-Cardiac death
Measured: 6month
MI
Any MI( periprocedural/spontaneous MI), Target vessel-MI and non-target vessel-MI
Measured: 6month
Stent thrombosis
definite/probable
Measured: 6month
Revascularization
Any revascularization,Target vessel and target lesion revascularization
Measured: 6month
Composite of event
Composite of all-cause death, myocardial infarction, stent thrombosis, or revascularization
Measured: 6month
Quality of life score assessed by the EQ-5D
The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
EQ-5D: the minimum and maximum values are 5 and 25 respectively. EQ VAS: the minimum and maximum values are 0 and 100 respectively.
Measured: 6month
Quality of life score assessed by Health-related Quality of Life Instrument with 8 Items (HINT-8)
HINT-8 was developed based on 4 health dimensions: physical, mental, social, and positive health dimensions. It consists of climbing stairs, endurance to pain, vitality, working, depression, memory, sleep, and happiness.
Measured: 6month
Cost-effective analysis
Cost-effective analysis based on average treatment costs for two treatment
Measured: 6month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start4 Oct 2022
- Primary completion30 Jun 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary VesselsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Medical Device Development Fund, Medipixel,Inc
- Responsible party
- Principal investigator, Jung-min Ahn, Asan Medical Center
- Investigators
- Jung- min Ahn, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388357
- Sponsor's protocol ID
- AMCCV2022-02
- Acronym
- FLASH
- Status last verified
- Oct 2024
- First submitted
- 10 May 2022
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim Y, Yoon HJ, Suh J, Kang SH, Lim YH, Jang DH, Park JH, Shin ES, Bae JW, Lee JH, Oh JH, Kang DY, Kweon J, Jo MW, Yun SC, Park DW, Kim YH, Park SJ, Park H, Ahn JM; FLASH Trial Investigators. Artificial Intelligence-Based Fully Automated Quantitative Coronary Angiography vs Optical Coherence Tomography-Guided PCI: The FLASH Trial. JACC Cardiovasc Interv. 2025 Jan 27;18(2):187-197. doi: 10.1016/j.jcin.2024.10.025. Epub 2024 Oct 30.
PubMed 39614852Kim Y, Park H, Yoon HJ, Suh J, Kang SH, Lim YH, Jang DH, Park JH, Shin ES, Bae JW, Lee JH, Oh JH, Kang DY, Kweon J, Jo MW, Park DW, Kim YH, Ahn JM; FLASH Trial Investigators. Fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation (FLASH): Study protocol for a randomized controlled noninferiority trial. Am Heart J. 2024 Sep;275:86-95. doi: 10.1016/j.ahj.2024.05.004. Epub 2024 May 7.
PubMed 38723880
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fully Automated Quantitative Coronary Angiography Versus Optical Coherent Tomography Guidance for Coronary Stent Implantation (FLASH): Multicenter, Randomized Controlled Non-Interiority Trial
- ClinicalTrials.gov ID
- NCT05388357
- Acronym / sponsor ID
- FLASH / AMCCV2022-02
- Conditions
- Coronary Vessels, Procedure PCI
- Keywords
- OCT, AI ,PCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Korea Medical Device Development Fund, Medipixel,Inc
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 24 May 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 is to establish the primary hypothesis thatAI -QCA guided PCI is non-inferior to Optical coherence tomography-guided Percutaneous coronary intervention regarding minimal Stent area by Final OCT and Procedural MACE
Detailed description
- AI-QCA-assisted DES implantation After coronary angiography, AI-QCA software will be used to determine the lesion length and the reference vessel diameter in real time to determine the appropriate stent size for implantation. The procedure is performed as follows:
- Select the optimal projection angle providing the best view of the lesion.
- Provide sufficient nitroglycerin for vasodilation. If the lesion is severely stenotic, perform balloon angioplasty, followed by nitroglycerin supply.
- Perform AI-QCA to measure the length of the lesion and the inside diameter of the proximal and distal reference vessels.
- Determine the stent length and size according to the AI-QCA measurements. Select a stent that is 20% larger than the distal reference vessel diameter and that can provide coverage for both the proximal and distal reference vessels.
- Perform high-pressure balloon dilation after stent implantation, with the final balloon size being 20% larger than the distal and proximal reference vessel diameters.
- Perform a final coronary angiogram if no procedural complications are observed on the angiogram and stent expansion is confirmed.
- Perform a final OCT to measure the stent area (mm2), the primary efficacy endpoint.
- If significant suboptimal stent results, such as severe underexpansion, extensive strut malapposition, or major stent edge dissection, occur, additional procedures to correct them are permitted to ensure patient safety, although they are generally discouraged. (The primary endpoint will be assessed by OCT run before such correction.)
- OCT guided DES implantation
After coronary angiography, OCT is performed to determine the appropriate stent size for implantation. After the stent procedure, OCT is performed again to check for an area that is smaller than the area of distal reference vessel and for sufficient dilatation. If necessary, high-pressure balloon dilation is performed to minimize residual stenosis. The procedure is performed as follows:
- Select the optimal projection angle providing the best view of the lesion.
- Provide sufficient nitroglycerin for vasodilation. If the lesion is severely stenotic, perform balloon angioplasty, followed by nitroglycerin supply.
- Perform OCT to obtain pre-procedural images of the vessel. If there is a stenosis and OCT images cannot be obtained, perform OCT after adequate balloon angioplasty.
- Determine the length and size of the stent to be implanted according to the OCT images. Select the stent size in consideration of the mean lumen diameter and mean external elastic lamina (EEL) diameter of the distal reference vessel. If the EEL is not observed, use a stent that is 0.25 mm larger than the mean lumen diameter. Select the length by measuring the length of the proximal and distal reference vessel segments on the OCT.
- Perform high-pressure balloon dilation after stent implantation. Select the final balloon size by considering the inside diameters of the distal and proximal reference vessels and EEL diameter.
- Perform OCT. If no procedure-related complications are observed and there is no underexpansion or malapposition of the stent, perform a final coronary angiogram. If procedure-related complications or underexpansion or malapposition of the stent is observed, correct it, and then perform a final OCT to measure the stent area (mm2), the primary efficacy endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI -guided PCI | Experimental | Other: Intervention Procedure: PCIbased on AI-QCA measurement, a drug eluting stent of an appropriate size is inserted and then high-pressure balloon dilatation is additionally actively performed in all patients. |
| OCT-guided PCI | Active comparator | Other: Intervention Procedure: PCIIn the OCT group, the size of the stent is determined using intravascular optical coherence tomography, and balloon dilatation is additionally performed if necessary. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women at least 19 years of age
- Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty.
- Subject with severe coronary artery disease undergoing PCI
- Written informed consent
Key exclusion criteria (10 listed)
- Angiographic exclusion criteria 1) Left main lesion 2) Chronic total occlusion 3)Graft vascular lesion 4) Requiring two-stent techniques for coronary bifurcation lesions 5)Any lesion characteristics resulting in the expected inability to deliver OCT catheter to the lesion ( eg,tortuosity, moderate or severe vessel calcification)
- Acute or chronic renal dysfunction (Plasma creatinine 2.0mg/dL or more) except patients undergoing dialysis
- Primary coronary angioplasty in ST-elevation myocardial infarction(within 12-24 hours of symptom onset)
- Previous PCI with BVS
- LV dysfunction (LVEF) < 30%
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 |
|---|---|---|
| Intervention Procedure: PCIPercutaneous Coronary Intervention | Other | AI -guided PCI, OCT-guided PCI |
Primary outcome
Minimal Stent Area evaluated by OCT
Time frame: 1hour
Minimal Stent Area evaluated by OCT after stenting of the target lesion
Procedural complications
Time frame: 24hours
Procedural complications including angiographic dissection, perforation, or acute closure requiring active intervention after stent implantation
11 secondary outcomes
Procedural success
Time frame: 24hours
OCT endpoint
Time frame: 24hours
Angiographic endpoint
Time frame: 24hours
Death
Time frame: 6month
MI
Time frame: 6month
Stent thrombosis
Time frame: 6month
Revascularization
Time frame: 6month
Composite of event
Time frame: 6month
Quality of life score assessed by the EQ-5D
Time frame: 6month
Quality of life score assessed by Health-related Quality of Life Instrument with 8 Items (HINT-8)
Time frame: 6month
Cost-effective analysis
Time frame: 6month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Derived from this study: PubMed 39614852Kim Y, Yoon HJ, Suh J, Kang SH, Lim YH, Jang DH, Park JH, Shin ES, Bae JW, Lee JH, Oh JH, Kang DY, Kweon J, Jo MW, Yun SC, Park DW, Kim YH, Park SJ, Park H, Ahn JM; FLASH Trial Investigators. Artificial Intelligence-Based Fully Automated Quantitative Coronary Angiography vs Optical Coherence Tomography-Guided PCI: The FLASH Trial. JACC Cardiovasc Interv. 2025 Jan 27;18(2):187-197. doi: 10.1016/j.jcin.2024.10.025. Epub 2024 Oct 30.
- Derived from this study: PubMed 38723880Kim Y, Park H, Yoon HJ, Suh J, Kang SH, Lim YH, Jang DH, Park JH, Shin ES, Bae JW, Lee JH, Oh JH, Kang DY, Kweon J, Jo MW, Park DW, Kim YH, Ahn JM; FLASH Trial Investigators. Fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation (FLASH): Study protocol for a randomized controlled noninferiority trial. Am Heart J. 2024 Sep;275:86-95. doi: 10.1016/j.ahj.2024.05.004. Epub 2024 May 7.
- 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.
Jung- min Ahn principal investigator
Asan Medical Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Procedure: PCI in people with Coronary Vessels and Procedure PCI, run by Asan Medical Center at 13 sites in South Korea.
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: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal Stent Area evaluated by OCT (time frame: 1hour). 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?
On the ClinicalTrials.gov record for NCT05388357, which also lists 2 linked publications.
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 24 Oct 2024.