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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCT-guided PCI | Procedure | 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.
|
| Measure | Description | Time Frame |
|---|---|---|
| Suboptimal post-PCI physiological results | Proportion of patients with a final post-interventional fractional flow reserve <0.85 | Immediate after the index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of target vessel failure (TVF) | a composite of cardiac death, target-vessel myocardial infarction (MI), and target-vessel revascularization (TVR) | 2 years after last patient enrollment |
| Rate of all-cause death |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of contrast-induced nephropathy | defined as an increase in serum creatinine of ≥0.5mg/dL or ≥25% from baseline after contrast agent exposure | 48-72 hours after index procedure |
| Total procedure time |
Inclusion Criteria:
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
Definitions of complex coronary lesions
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Youngkeun Ahn, MD, PhD | Chonnam National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hospital | Gwangju | 61469 | South Korea | |||
| Chung-Ang University Gwangmyeong Hospital |
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
1 year after study completion
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: V3.2 | Sep 27, 2025 |
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|
| Angiography-guided PCI | Procedure | 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 stent | Device | All patient will be received percutaneous coronary intervention with second generation drug-eluting stent. |
|
death from any-cause
| 2 years after last patient enrollment |
| Rate of cardiac death | death from cardiac-cause | 2 years after last patient enrollment |
| Rate of target vessel MI without periprocedural MI | Myocardial infarction without periprocedural myocardial infarction | 2 years after last patient enrollment |
| Rate of target vessel MI with periprocedural MI | Myocardial infarction with periprocedural myocardial infarction | 2 years after last patient enrollment |
| Rate of target lesion revascularization (TLR) | ischemia-driven or all | 2 years after last patient enrollment |
| Rate of target vessel revascularization (TVR) | ischemia-driven or all | 2 years after last patient enrollment |
| Rate of any MI | any myocardial infarction | 2 years after last patient enrollment |
| Rate of any revascularization | ischemia-driven or all | 2 years after last patient enrollment |
| Rate of stent thrombosis | definite, probable, or possible | 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] | Immediate after the index procedure |
| Trans-stent FFR gradient | FFR gradient across the stent (ΔFFRstent) | Immediate after the index procedure |
| Post-interventional non-hyperemic pressure ratios | Values of post-PCI non-hyperemic pressure ratios | Immediate after the index procedure |
Total procedure time
| Immediate after the index procedure |
| Total amount of contrast dose | Total amount of contrast dose | Immediate after the index procedure |
| Total fluoroscopy time | Total fluoroscopy time | Immediate after the index procedure |
| Total amount of radiation dose | Total amount of radiation dose | Immediate after the index procedure |
| Gwangmyeong |
| South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| May 26, 2026 |
| Prot_SAP_004.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: V3.1 | Aug 23, 2024 | Apr 18, 2025 | Prot_SAP_003.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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