Coronary Artery DiseaseNCT05493904
PREcise Percutaneous Coronary Intervention for Stent OptimizatION in Treatment of COMPLEX Lesion (PRECISION-COMPLEX)
A study testing OCT-guided PCI, Angiography-guided PCI and Drug-eluting stent in people with Coronary Artery Disease and Angina Pectoris, run by Chonnam National University Hospital at 4 sites in South Korea.
Trial summary
The aim of the study is to compare post-interventional fractional flow reserve (FFR) value between optical coherence tomography(OCT)-guided and angiography-guided strategy for treatment of complex coronary lesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Angina Pectoris
- What is being tested?
- OCT-guided PCI, Angiography-guided PCI and Drug-eluting stent
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 1 Nov 2022to 31 Dec 2027
- 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
- Patients >18 years old
- Patients with stable or unstable angina and complex coronary lesions*
- Patients who were indicated revascularization
- Diameter stenosis >90% by angiography
- Diameter stenosis with 50~90% with pre-interventional FFR ≤0.80
- Patients who underwent implantation of 2nd generation drug-eluting stent
Show all 16Show fewer
- Definitions of complex coronary lesions
- True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size
- Chronic total occlusion (≥3 months) as target lesion
- PCI for unprotected left main (LM) disease (LM os, body, distal LM bifurcation including non-true bifurcation)
- Long coronary lesions (implanted stent ≥38 mm in length)
- Multi-vessel PCI (≥2 major epicardial coronary arteries treated at one PCI session)
- Multiple stents needed (≥3 more stent per patient)
- In-stent restenosis lesion as target lesion
- Severely calcified lesion (encircling calcium in angiography)
- Left anterior descending (LAD), left circumflex artery (LCX), and right coronary artery (RCA) ostial lesion
Who cannot join
- Target lesions not amenable for PCI by operators' decision
- Cardiogenic shock (Killip class IV) at presentation
- Less than TIMI 3 flow of target vessel after index procedure
- Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Everolimus, Zotarolimus, Biolimus, or Sirolimus
- Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
- Renal insufficiency such that an additional contrast medium would be harmful for patient
Show all 11Show fewer
- Recent ST-segment elevation myocardial infarction (STEMI)
- Inability to receive adenosine or nicorandil injection
- Pregnancy or breast feeding
- Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- Unwillingness or inability to comply with the procedures described in this protocol
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Chonnam National University Hospital
Gwangju, 61469
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: Impact of Optical Coherence Tomography-guided Versus Angiography-guided Stent Optimization on Post-Interventional Fractional Flow Reserve in Patients With Complex Coronary Artery Lesions
The aim of the study is to compare post-interventional fractional flow reserve (FFR) value between optical coherence tomography(OCT)-guided and angiography-guided strategy for treatment of complex coronary lesion.
Read the detailed description
There has been ample evidence of the role of intracoronary imaging for optimizing the stent, especially among the patients with complex coronary lesions. Intracoronary imaging can be used during the entire process of percutaneous coronary intervention (PCI), from pre-PCI to post-PCI stages. Notably, approximately 15-20% of patients who underwent angiographically successful PCI showed significant stent underexpansion, malapposition, intra-stent thrombus formation, and edge dissection on intracoronary imaging studies, including optical coherence tomography (OCT).
Meanwhile, the role of pre-interventional fractional flow reserve (FFR) measurement has been well established and recommended by recent guideline. However, although previous studies evaluated the efficacy and safety of FFR-guided decision-making followed by angiographic stent implantation, they did not evaluate functionally optimized revascularization. Actually, the vessels with low post-PCI FFR had substantial proportions of suboptimized stented (underexpansion and acute malapposition) and residual disease in non-stented segments. Furthermore, several large observational studies have suggested that suboptimal physiologic results after PCI is associated with an increased risk of clinical events. Previously, the DOCTORS trial found out that OCT-guided PCI was associated with higher post-PCI FFR than angiography-guided PCI (0.94±0.04 vs. 0.92±0.05, P=0.005).
Therefore, OCT can be a useful tool for acquiring functional optimal results after stent implantation. This synergic effect between OCT and post-PCI FFR can be maximized when the investigators perform PCI for complex lesions. This study sought to evaluate compare post-interventional FFR value between OCT-guided and angiography-guided strategy for treatment of complex coronary lesion.
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Being tested
- OCT-guided PCI, Angiography-guided PCI, Drug-eluting stent
- Keywords
- Percutaneous Coronary Intervention, Intravascular Imaging, Optical Coherence Tomography, Fractional Flow Reserve, Complex Lesion
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT-guided PCIProcedure or surgery
For patients randomly allocated to this arm, PCI for complex lesions will be performed using OCT.
OCT Reference site: Most normal looking segment, No Lipidic plaque. Operator can decide 1 of 2 methods for stent sizing.
- By measuring vessel diameter at the distal reference sites (in case of ≥180° of the external elastic membrane [EEL] can be identified). In this case, stent diameter will be determined using mean external elastic membrane diameter at the distal reference, rounded down to the nearest 0.25mm (Ex> mean external elastic membrane reference diameter 3.35mm, 3.25mm stent diameter will be chosen).
- By measuring lumen diameter at the distal reference sites (in case of ≥180° of the external elastic membrane cannot be identified). In this case, stent diameter will be determined using mean lumen diameter at the distal reference, rounded up to the nearest 0.25mm (Ex> mean distal reference lumen diameter 2.55mm, 2.75mm stent diameter will be chosen).
Angiography-guided PCIProcedure or surgery
For patients randomly allocated to this arm, PCI for complex lesions will be performed using angiography only.
The optimization guided by angiography should meet the criteria of angiographic residual diameter stenosis less than 30% by visual estimation and the absence of flow limiting dissection (≥Type C dissection). When angiographic under-expansion of the stent is suspected, adjunctive balloon dilatation will be strongly recommended.
Drug-eluting stentDevice
All patient will be received percutaneous coronary intervention with second generation drug-eluting stent.
| Study group | Role | What they receive |
|---|---|---|
| OCT-guided PCI arm | Active comparator | Use of OCT will be strongly recommended at any step of PCI (pre-PCI, during PCI and post-PCI), but OCT evaluation after stent implantation will be mandatory. In case of staged procedure during the same hospitalization, following the initially allocated strategy would be strongly recommended. Receives: Procedure: OCT-guided PCI; Device: Drug-eluting stent |
| Angiography-guided PCI arm | Active comparator | The PCI procedure in this group will be performed as standard procedure. After deployment of stent, stent optimization will be done based on angiographic findings. In case of staged procedure during the same hospitalization, following the initially allocated strategy would be strongly recommended. Receives: Procedure: Angiography-guided PCI; Device: Drug-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suboptimal post-PCI physiological results
Proportion of patients with a final post-interventional fractional flow reserve <0.85
Measured: Immediate after the index procedure
Secondary outcomes (13)
Rate of target vessel failure (TVF)
a composite of cardiac death, target-vessel myocardial infarction (MI), and target-vessel revascularization (TVR)
Measured: 2 years after last patient enrollment
Rate of all-cause death
death from any-cause
Measured: 2 years after last patient enrollment
Rate of cardiac death
death from cardiac-cause
Measured: 2 years after last patient enrollment
Rate of target vessel MI without periprocedural MI
Myocardial infarction without periprocedural myocardial infarction
Measured: 2 years after last patient enrollment
Rate of target vessel MI with periprocedural MI
Myocardial infarction with periprocedural myocardial infarction
Measured: 2 years after last patient enrollment
Rate of target lesion revascularization (TLR)
ischemia-driven or all
Measured: 2 years after last patient enrollment
Rate of target vessel revascularization (TVR)
ischemia-driven or all
Measured: 2 years after last patient enrollment
Rate of any MI
any myocardial infarction
Measured: 2 years after last patient enrollment
Rate of any revascularization
ischemia-driven or all
Measured: 2 years after last patient enrollment
Rate of stent thrombosis
definite, probable, or possible
Measured: 2 years after last patient enrollment
FFR gain between pre- and post-interventional stages
[Post-interventional fractional flow reserve value] - [Pre-interventional fractional flow reserve value]
Measured: Immediate after the index procedure
Trans-stent FFR gradient
FFR gradient across the stent (ΔFFRstent)
Measured: Immediate after the index procedure
Post-interventional non-hyperemic pressure ratios
Values of post-PCI non-hyperemic pressure ratios
Measured: Immediate after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Nov 2022
- Primary completion5 Dec 2024
- Study completion31 Dec 2027 (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
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, Seung Hun Lee, Chonnam National University Hospital
- Investigators
- Youngkeun Ahn, MD, PhD, Study chair, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493904
- Sponsor's protocol ID
- CNUH-2022-283
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2022
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Optical Coherence Tomography-guided Versus Angiography-guided Stent Optimization on Post-Interventional Fractional Flow Reserve in Patients With Complex Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT05493904
- Acronym / sponsor ID
- CNUH-2022-283
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Keywords
- Percutaneous Coronary Intervention, Intravascular Imaging, Optical Coherence Tomography, Fractional Flow Reserve, Complex Lesion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Aug 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.
The aim of the study is to compare post-interventional fractional flow reserve (FFR) value between optical coherence tomography(OCT)-guided and angiography-guided strategy for treatment of complex coronary lesion.
Detailed description
There has been ample evidence of the role of intracoronary imaging for optimizing the stent, especially among the patients with complex coronary lesions. Intracoronary imaging can be used during the entire process of percutaneous coronary intervention (PCI), from pre-PCI to post-PCI stages. Notably, approximately 15-20% of patients who underwent angiographically successful PCI showed significant stent underexpansion, malapposition, intra-stent thrombus formation, and edge dissection on intracoronary imaging studies, including optical coherence tomography (OCT).
Meanwhile, the role of pre-interventional fractional flow reserve (FFR) measurement has been well established and recommended by recent guideline. However, although previous studies evaluated the efficacy and safety of FFR-guided decision-making followed by angiographic stent implantation, they did not evaluate functionally optimized revascularization. Actually, the vessels with low post-PCI FFR had substantial proportions of suboptimized stented (underexpansion and acute malapposition) and residual disease in non-stented segments. Furthermore, several large observational studies have suggested that suboptimal physiologic results after PCI is associated with an increased risk of clinical events. Previously, the DOCTORS trial found out that OCT-guided PCI was associated with higher post-PCI FFR than angiography-guided PCI (0.94±0.04 vs. 0.92±0.05, P=0.005).
Therefore, OCT can be a useful tool for acquiring functional optimal results after stent implantation. This synergic effect between OCT and post-PCI FFR can be maximized when the investigators perform PCI for complex lesions. This study sought to evaluate compare post-interventional FFR value between OCT-guided and angiography-guided strategy for treatment of complex coronary lesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT-guided PCI arm | Active comparator | Procedure: OCT-guided PCI, Device: Drug-eluting stentUse of OCT will be strongly recommended at any step of PCI (pre-PCI, during PCI and post-PCI), but OCT evaluation after stent implantation will be mandatory. In case of staged procedure during the same hospitalization, following the initially allocated strategy would be strongly recommended. |
| Angiography-guided PCI arm | Active comparator | Procedure: Angiography-guided PCI, Device: Drug-eluting stentThe PCI procedure in this group will be performed as standard procedure. After deployment of stent, stent optimization will be done based on angiographic findings. In case of staged procedure during the same hospitalization, following the initially allocated strategy would be strongly recommended. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients >18 years old
- Patients with stable or unstable angina and complex coronary lesions*
- Patients who were indicated revascularization
- Patients who underwent implantation of 2nd generation drug-eluting stent
Key exclusion criteria (11 listed)
- Target lesions not amenable for PCI by operators' decision
- Cardiogenic shock (Killip class IV) at presentation
- Less than TIMI 3 flow of target vessel after index procedure
- Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Everolimus, Zotarolimus, Biolimus, or Sirolimus
- Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
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 |
|---|---|---|
| OCT-guided PCIFor patients randomly allocated to this arm, PCI for complex lesions will be performed using OCT. OCT Reference site: Most normal looking segment, No Lipidic plaque. Operator can decide 1 of 2 methods for stent sizing. 1. By measuring vessel diameter at the distal reference sites (in case of ≥180° of the external elastic membrane [EEL] can be identified). In this case, stent diameter will be determined using mean external elastic membrane diameter at the distal reference, rounded down to the nearest 0.25mm (Ex> mean external elastic membrane reference diameter 3.35mm, 3.25mm stent diameter will be chosen). 2. By measuring lumen diameter at the distal reference sites (in case of ≥180° of the external elastic membrane cannot be identified). In this case, stent diameter will be determined using mean lumen diameter at the distal reference, rounded up to the nearest 0.25mm (Ex> mean distal reference lumen diameter 2.55mm, 2.75mm stent diameter will be chosen). | Procedure or surgery | OCT-guided PCI arm |
| Angiography-guided PCIFor patients randomly allocated to this arm, PCI for complex lesions will be performed using angiography only. The optimization guided by angiography should meet the criteria of angiographic residual diameter stenosis less than 30% by visual estimation and the absence of flow limiting dissection (≥Type C dissection). When angiographic under-expansion of the stent is suspected, adjunctive balloon dilatation will be strongly recommended. | Procedure or surgery | Angiography-guided PCI arm |
| Drug-eluting stentAll patient will be received percutaneous coronary intervention with second generation drug-eluting stent. | Device | Angiography-guided PCI arm, OCT-guided PCI arm |
Primary outcome
Suboptimal post-PCI physiological results
Time frame: Immediate after the index procedure
Proportion of patients with a final post-interventional fractional flow reserve <0.85
13 secondary outcomes
Rate of target vessel failure (TVF)
Time frame: 2 years after last patient enrollment
Rate of all-cause death
Time frame: 2 years after last patient enrollment
Rate of cardiac death
Time frame: 2 years after last patient enrollment
Rate of target vessel MI without periprocedural MI
Time frame: 2 years after last patient enrollment
Rate of target vessel MI with periprocedural MI
Time frame: 2 years after last patient enrollment
Rate of target lesion revascularization (TLR)
Time frame: 2 years after last patient enrollment
Rate of target vessel revascularization (TVR)
Time frame: 2 years after last patient enrollment
Rate of any MI
Time frame: 2 years after last patient enrollment
Rate of any revascularization
Time frame: 2 years after last patient enrollment
Rate of stent thrombosis
Time frame: 2 years after last patient enrollment
FFR gain between pre- and post-interventional stages
Time frame: Immediate after the index procedure
Trans-stent FFR gradient
Time frame: Immediate after the index procedure
Post-interventional non-hyperemic pressure ratios
Time frame: Immediate after the index procedure
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 28 Aug 2026.
- Individual participant dataSharing planned: Yes. After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
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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.
Youngkeun Ahn, MD, PhD study chair
Chonnam National University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT-guided PCI, Angiography-guided PCI and Drug-eluting stent in people with Coronary Artery Disease and Angina Pectoris, run by Chonnam National University Hospital at 4 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 16 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 28 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 4 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?
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?
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?
Suboptimal post-PCI physiological results (time frame: Immediate after the index procedure). 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 28 Aug 2026.