Coronary Artery DiseaseSCOPE-HRNCT07324720
Strategic Comparison Of Ischemia-based Versus Plaque Burden and vulnErability-based Revascularization in High-Risk Coronary Artery Disease Patients
A study testing Plaque burden and vulnerability-based revascularization and Ischemia-based revascularization in people with Coronary Artery Disease, run by Bon-Kwon Koo at 1 site in South Korea.
Trial summary
1. Study Purpose This study aims to compare clinical outcomes between two revascularization strategies in patients with high-risk coronary artery disease and 50-90% angiographic stenosis: a plaque burden and vulnerability-based revascularization strategy guided by intravascular imaging versus an ischemia-based… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Plaque burden and vulnerability-based revascularization and Ischemia-based revascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,944 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Apr 2026to 24 Sep 2033
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ① Patients aged 19 years or older
- ② Patients with moderate to severe coronary artery stenosis identified on coronary angiography:
- Diameter stenosis of 50%-90% by visual estimation B. De novo lesions (newly developed lesions) C. Reference vessel diameter ≥ 2.5 mm by visual estimation
- ③ Patients with either clinically high-risk features for recurrent ischemic events or complex high-risk lesions identified on angiography:
- Clinically high-risk features i. Medically treated diabetes mellitus ii. Chronic kidney disease (≥ Stage 3B, eGFR < 45 mL/min/1.73 m²) iii. Acute coronary syndrome (ACS) iv. Previous myocardial infarction (MI)
- Complex high-risk lesions i. True bifurcation lesions ii. Calcified lesions (moderate to severe calcification on angiography) iii. Diffuse long lesions (≥ 30 mm in length) iv. Multivessel disease v. Multiple lesions (≥ 3 lesions)
- ④ Patients who can verbally demonstrate an understanding of the risks, benefits, and alternative treatments of invasive physiologic or imaging assessment and PCI
- ⑤ Patients who agree to the study protocol and clinical follow-up plan, voluntarily decide to participate, and provide written informed consent to participate in this clinical trial
Who cannot join
- Hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, adenosine, or nicorandil
- Hemodynamic instability requiring mechanical circulatory support (ECMO or IABP)
- Moderate or severe stenosis of the left main coronary artery (diameter stenosis > 50%)
- History of coronary artery bypass grafting (CABG)
- Severe asthma or severe chronic obstructive pulmonary disease (COPD) ⑥ Active bleeding
- ⑦ Major gastrointestinal or genitourinary bleeding within the previous 3 months
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- ⑧ Bleeding diathesis or known coagulopathy, including a history of heparin-induced thrombocytopenia (HIT)
- ⑨ Life expectancy < 2 years due to non-cardiovascular comorbidities
- ⑩ Inability to provide signed informed consent
- ⑪ Any condition deemed by the investigator to make the patient unsuitable for this clinical trial or likely to increase study-related risks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Main Building, 03080
Doyeon Hwang, MD, 8220724345, cardiol.intv@gmail.com
About this study
- Study Purpose This study aims to compare clinical outcomes between two revascularization strategies in patients with high-risk coronary artery disease and 50-90% angiographic stenosis: a plaque burden and vulnerability-based revascularization strategy guided by intravascular imaging versus an ischemia-based revascularization strategy guided by physiologic assessment.
- Background Percutaneous coronary intervention (PCI), in conjunction with optimal medical therapy, is one of the main therapeutic strategies for improving outcomes in patients with CAD. To enhance the results of PCI, various diagnostic and adjunctive techniques have been developed-most notably, invasive physiologic assessment and intravascular imaging (IVI). Invasive physiologic indices such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are recognized as the most accurate methods to determine vessel-level myocardial ischemia, and current guidelines recommend PCI based on these physiological measurements. Recently, angiography-derived FFR has also been developed, allowing ischemia assessment without pressure wire measurement, and has been endorsed as a useful tool for guiding PCI decisions. Intravascular imaging, on the other hand, provides detailed anatomical insights into atherosclerotic plaque morphology and plays a critical role in achieving procedural optimization. Current guidelines recommend the use of IVI, particularly in the treatment of complex lesions. While most previous IVI studies have focused on procedural optimization, more recent investigations have begun to explore the use of IVI for PCI decision-making itself. Emerging data suggest that revascularization decisions based on quantitative and qualitative plaque assessment using IVI are non-inferior to those based on invasive physiologic testing. Moreover, IVI enables the identification of vulnerable plaques, and studies indicate that intervening on such lesions may improve outcomes. At present, a physiology-guided decision-making strategy combined with IVI-guided optimization is considered the best evidence-based approach according to guidelines. However, recent data showing the potential advantages of IVI-guided decision-making and IVI-guided optimization-particularly in high-risk, complex patients and in those with vulnerable plaque morphology-suggest that IVI-based strategies may offer greater clinical benefit in such populations. Despite this, a comprehensive strategy that integrates both quantitative (plaque burden) and qualitative (vulnerability) aspects of plaque evaluation via IVI has yet to be clearly established. Therefore, this study seeks to propose IVI-based quantitative and qualitative criteria for high-risk CAD patients and to compare outcomes between a plaque burden and vulnerability-based revascularization strategy and the conventional ischemia-based revascularization strategy. For all patients undergoing PCI, IVI-guided optimization will be performed to ensure the highest possible procedural quality in both groups.
- Study Procedures Patients undergoing coronary angiography for suspected or known CAD will be screened for eligibility. After providing a detailed explanation of the study, written informed consent will be obtained from those deemed appropriate for participation. Following coronary angiography, patients with significant coronary stenosis who meet all inclusion and no exclusion criteria will be enrolled in the study. Eligible participants will then be randomized in a 1:1 ratio to either the plaque burden and vulnerability-based revascularization group or the ischemia-based revascularization group. Stratified randomization will be performed according to participating center and presence or absence of acute coronary syndrome (ACS) to ensure balance between the groups.
- Conditions
- Coronary Artery Disease
- Being tested
- Plaque burden and vulnerability-based revascularization, Ischemia-based revascularization
- 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.
Plaque burden and vulnerability-based revascularizationProcedure or surgery
For target lesions located in vessels with a reference diameter ≥2.5 mm, quantitative and qualitative plaque assessment will be performed using intravascular imaging. The criteria for revascularization are as follows:
- When using IVUS: Revascularization will be considered for lesions with a minimum lumen area (MLA) < 4 mm² if any of the following findings are present:
- Plaque burden > 70%
- Plaque rupture ③ Thrombosis ④ Posterior attenuation without high-intensity echo reflectors (involving > 180° of the vessel circumference) ⑤ maxLCBI₄mm > 315 on near-infrared spectroscopy (NIRS)
- When using OCT:
Revascularization will be considered for lesions with a minimum lumen area (MLA) < 3.5 mm² if any of the following findings are present:
- Area stenosis ≥ 75%
- Plaque rupture
- Presence of a thin fibrous cap < 65 μm on plaque with lipid arc > 90° ④ Lipid arc > 180° ⑤ Macrophage infiltration
Ischemia-based revascularizationProcedure or surgery
For target lesions located in vessels with a reference diameter ≥2.5 mm, the presence or absence of myocardial ischemia will be evaluated using FFR, iFR, or angiography-derived FFR. The criteria for revascularization are as follows:
- Lesions with ≥50% diameter stenosis by visual estimation and FFR ≤ 0.80
- Lesions with ≥50% diameter stenosis by visual estimation and iFR ≤ 0.89
- Lesions with ≥50% diameter stenosis by visual estimation and angiography-derived FFR ≤ 0.80
| Study group | Role | What they receive |
|---|---|---|
| Plaque burden and vulnerability-based revascularization | Experimental | Percutaneous coronary intervention using drug-eluting stent(s) will be performed by IVUS or OCT-guided strategy. Receives: Procedure: Plaque burden and vulnerability-based revascularization |
| Ischemia-based revascularization | Active comparator | Percutaneous coronary intervention using drug-eluting stent(s) will be performed by FFR, iFR, or angiography-derived FFR-guided strategy. Receives: Procedure: Ischemia-based revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vessel failure
a composite of cardiovascular death, target vessel spontaneous myocardial infarction and ischemia-driven target vessel revascularization
Measured: 2 years after last patient enrollment
Secondary outcomes (14)
Patient-oriented composite outcome
a composite of all cause of death, any spontaneous myocardial infarction and any repeat revascularization
Measured: 2 years after last patient enrollment
Target lesion failure
a composite of cardiovascular death, target vessel spontaneous myocardial infarction and ischemia-driven target lesion revascularization
Measured: 2 years after last patient enrollment
All cause death
Measured: 2 years after last patient enrollment
Cardiovascular death
Measured: 2 years after last patient enrollment
Any spontaneous myocardial infarction
Measured: 2 years after last patient enrollment
Peri-procedural myocardial infarction
Measured: 3 days after procedure
Target vessel spontaneous myocardial infarction
Measured: 2 years after last patient enrollment
Definite or probable stent thrombosis
Measured: 2 years after last patient enrollment
Ischemic or hemorrhagic stroke
Measured: 2 years after last patient enrollment
Any revascularization
Measured: 2 years after last patient enrollment
Ischemia-driven target vessel revascularization
Measured: 2 years after last patient enrollment
Ischemia-driven target lesion revascularization
Measured: 2 years after last patient enrollment
Number of stents used per patient or lesion
Measured: After procedure
Bleeding Academic Research Consortium [BARC] type 2,3, or 5
Measured: 2 years after last patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start27 Apr 2026
- Primary completion24 Sep 2033 (estimated)
- Study completion24 Sep 2033 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,944 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bon-Kwon Koo
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul St. Mary's Hospital
- Responsible party
- Sponsor-investigator, Bon-Kwon Koo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324720
- Sponsor's protocol ID
- 2508-177-1673
- Acronym
- SCOPE-HR
- Status last verified
- Aug 2026
- First submitted
- 23 Dec 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic Comparison Of Ischemia-based Versus Plaque Burden and vulnErability-based Revascularization in High-Risk Coronary Artery Disease Patients
- ClinicalTrials.gov ID
- NCT07324720
- Acronym / sponsor ID
- SCOPE-HR / 2508-177-1673
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,944 participants (estimated)
- Lead sponsor
- Bon-Kwon KooUniversity, hospital or other
- Collaborators
- Seoul St. Mary's Hospital
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 24 Sep 2033 (estimated)
- Study completion
- 24 Sep 2033 (estimated)
- First posted
- 7 Jan 2026 (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.
- Study Purpose This study aims to compare clinical outcomes between two revascularization strategies in patients with high-risk coronary artery disease and 50-90% angiographic stenosis: a plaque burden and vulnerability-based revascularization strategy guided by intravascular imaging versus an ischemia-based revascularization strategy guided by physiologic assessment.
- Background Percutaneous coronary intervention (PCI), in conjunction with optimal medical therapy, is one of the main therapeutic strategies for improving outcomes in patients with CAD. To enhance the results of PCI, various diagnostic and adjunctive techniques have been developed-most notably, invasive physiologic assessment and intravascular imaging (IVI). Invasive physiologic indices such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are recognized as the most accurate methods to determine vessel-level myocardial ischemia, and current guidelines recommend PCI based on these physiological measurements. Recently, angiography-derived FFR has also been developed, allowing ischemia assessment without pressure wire measurement, and has been endorsed as a useful tool for guiding PCI decisions. Intravascular imaging, on the other hand, provides detailed anatomical insights into atherosclerotic plaque morphology and plays a critical role in achieving procedural optimization. Current guidelines recommend the use of IVI, particularly in the treatment of complex lesions. While most previous IVI studies have focused on procedural optimization, more recent investigations have begun to explore the use of IVI for PCI decision-making itself. Emerging data suggest that revascularization decisions based on quantitative and qualitative plaque assessment using IVI are non-inferior to those based on invasive physiologic testing. Moreover, IVI enables the identification of vulnerable plaques, and studies indicate that intervening on such lesions may improve outcomes. At present, a physiology-guided decision-making strategy combined with IVI-guided optimization is considered the best evidence-based approach according to guidelines. However, recent data showing the potential advantages of IVI-guided decision-making and IVI-guided optimization-particularly in high-risk, complex patients and in those with vulnerable plaque morphology-suggest that IVI-based strategies may offer greater clinical benefit in such populations. Despite this, a comprehensive strategy that integrates both quantitative (plaque burden) and qualitative (vulnerability) aspects of plaque evaluation via IVI has yet to be clearly established. Therefore, this study seeks to propose IVI-based quantitative and qualitative criteria for high-risk CAD patients and to compare outcomes between a plaque burden and vulnerability-based revascularization strategy and the conventional ischemia-based revascularization strategy. For all patients undergoing PCI, IVI-guided optimization will be performed to ensure the highest possible procedural quality in both groups.
- Study Procedures Patients undergoing coronary angiography for suspected or known CAD will be screened for eligibility. After providing a detailed explanation of the study, written informed consent will be obtained from those deemed appropriate for participation. Following coronary angiography, patients with significant coronary stenosis who meet all inclusion and no exclusion criteria will be enrolled in the study. Eligible participants will then be randomized in a 1:1 ratio to either the plaque burden and vulnerability-based revascularization group or the ischemia-based revascularization group. Stratified randomization will be performed according to participating center and presence or absence of acute coronary syndrome (ACS) to ensure balance between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plaque burden and vulnerability-based revascularization | Experimental | Procedure: Plaque burden and vulnerability-based revascularizationPercutaneous coronary intervention using drug-eluting stent(s) will be performed by IVUS or OCT-guided strategy. |
| Ischemia-based revascularization | Active comparator | Procedure: Ischemia-based revascularizationPercutaneous coronary intervention using drug-eluting stent(s) will be performed by FFR, iFR, or angiography-derived FFR-guided strategy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ① Patients aged 19 years or older
- ② Patients with moderate to severe coronary artery stenosis identified on coronary angiography:
- Diameter stenosis of 50%-90% by visual estimation B. De novo lesions (newly developed lesions) C. Reference vessel diameter ≥ 2.5 mm by visual estimation
- ③ Patients with either clinically high-risk features for recurrent ischemic events or complex high-risk lesions identified on angiography:
- Clinically high-risk features i. Medically treated diabetes mellitus ii. Chronic kidney disease (≥ Stage 3B, eGFR < 45 mL/min/1.73 m²) iii. Acute coronary syndrome (ACS) iv. Previous myocardial infarction (MI)
Key exclusion criteria (10 listed)
- Hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, adenosine, or nicorandil
- ⑦ Major gastrointestinal or genitourinary bleeding within the previous 3 months
- ⑧ Bleeding diathesis or known coagulopathy, including a history of heparin-induced thrombocytopenia (HIT)
- ⑨ Life expectancy < 2 years due to non-cardiovascular comorbidities
- ⑩ Inability to provide signed 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 |
|---|---|---|
| Plaque burden and vulnerability-based revascularizationFor target lesions located in vessels with a reference diameter ≥2.5 mm, quantitative and qualitative plaque assessment will be performed using intravascular imaging. The criteria for revascularization are as follows: 1. When using IVUS: Revascularization will be considered for lesions with a minimum lumen area (MLA) < 4 mm² if any of the following findings are present: * Plaque burden > 70% * Plaque rupture ③ Thrombosis ④ Posterior attenuation without high-intensity echo reflectors (involving > 180° of the vessel circumference) ⑤ maxLCBI₄mm > 315 on near-infrared spectroscopy (NIRS) 2. When using OCT: Revascularization will be considered for lesions with a minimum lumen area (MLA) < 3.5 mm² if any of the following findings are present: * Area stenosis ≥ 75% * Plaque rupture * Presence of a thin fibrous cap < 65 μm on plaque with lipid arc > 90° ④ Lipid arc > 180° ⑤ Macrophage infiltration | Procedure or surgery | Plaque burden and vulnerability-based revascularization |
| Ischemia-based revascularizationFor target lesions located in vessels with a reference diameter ≥2.5 mm, the presence or absence of myocardial ischemia will be evaluated using FFR, iFR, or angiography-derived FFR. The criteria for revascularization are as follows: 1. Lesions with ≥50% diameter stenosis by visual estimation and FFR ≤ 0.80 2. Lesions with ≥50% diameter stenosis by visual estimation and iFR ≤ 0.89 3. Lesions with ≥50% diameter stenosis by visual estimation and angiography-derived FFR ≤ 0.80 | Procedure or surgery | Ischemia-based revascularization |
Primary outcome
Target vessel failure
Time frame: 2 years after last patient enrollment
a composite of cardiovascular death, target vessel spontaneous myocardial infarction and ischemia-driven target vessel revascularization
14 secondary outcomes
Patient-oriented composite outcome
Time frame: 2 years after last patient enrollment
Target lesion failure
Time frame: 2 years after last patient enrollment
All cause death
Time frame: 2 years after last patient enrollment
Cardiovascular death
Time frame: 2 years after last patient enrollment
Any spontaneous myocardial infarction
Time frame: 2 years after last patient enrollment
Peri-procedural myocardial infarction
Time frame: 3 days after procedure
Target vessel spontaneous myocardial infarction
Time frame: 2 years after last patient enrollment
Definite or probable stent thrombosis
Time frame: 2 years after last patient enrollment
Ischemic or hemorrhagic stroke
Time frame: 2 years after last patient enrollment
Any revascularization
Time frame: 2 years after last patient enrollment
Ischemia-driven target vessel revascularization
Time frame: 2 years after last patient enrollment
Ischemia-driven target lesion revascularization
Time frame: 2 years after last patient enrollment
Number of stents used per patient or lesion
Time frame: After procedure
Bleeding Academic Research Consortium [BARC] type 2,3, or 5
Time frame: 2 years after last patient enrollment
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 27 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plaque burden and vulnerability-based revascularization and Ischemia-based revascularization in people with Coronary Artery Disease, run by Bon-Kwon Koo at 1 site 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 8 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: looking for participants now, as of the sponsor's last update on 27 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 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?
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 Bon-Kwon Koo, MD., PhD. (82-2-2072-7433, bkkoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vessel failure (time frame: 2 years after last patient enrollment). 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 27 Aug 2026.