OCT-guided PCI: 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.
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).
Angiography-guided PCI: 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: All patient will be received percutaneous coronary intervention with second generation drug-eluting stent.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patients \>18 years old
2. Patients with stable or unstable angina and complex coronary lesions\*
3. Patients who were indicated revascularization
* Diameter stenosis \>90% by angiography
* Diameter stenosis with 50\~90% with pre-interventional FFR ≤0.80
4. Patients who underwent implantation of 2nd generation drug-eluting stent
* Definitions of complex coronary lesions
1. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size
2. Chronic total occlusion (≥3 months) as target lesion
3. PCI for unprotected left main (LM) disease (LM os, body, distal LM bifurcation including non-true bifurcation)
4. Long coronary lesions (implanted stent ≥38 mm in length)
5. Multi-vessel PCI (≥2 major epicardial coronary arteries treated at one PCI session)
6. Multiple stents needed (≥3 more stent per patient)
7. In-stent restenosis lesion as target lesion
8. Severely calcified lesion (encircling calcium in angiography)
9. Left anterior descending (LAD), left circumflex artery (LCX), and right coronary artery (RCA) ostial lesion
Exclusion Criteria:
1. Target lesions not amenable for PCI by operators' decision
2. Cardiogenic shock (Killip class IV) at presentation
3. Less than TIMI 3 flow of target vessel after index procedure
4. Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Everolimus, Zotarolimus, Biolimus, or Sirolimus
5. Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
6. Renal insufficiency such that an additional contrast medium would be harmful for patient
7. Recent ST-segment elevation myocardial infarction (STEMI)
8. Inability to receive adenosine or nicorandil injection
9. Pregnancy or breast feeding
10. 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)
11. Unwillingness or inability to comply with the procedures described in this protocol
Primary outcome measure(s)
Suboptimal post-PCI physiological results — Immediate after the index procedure Proportion of patients with a final post-interventional fractional flow reserve \<0.85
Trial sites (4)
Facility
City
Region
Status
Chonnam National University Hospital
Gwangju
South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong
South Korea
Samsung Medical Center
Seoul
South Korea
Seoul National University Hospital
Seoul
South Korea
More Chonnam National University Hospital trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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