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ACTIVE NOT RECRUITING

NCT05493904

PREcise Percutaneous Coronary Intervention for Stent OptimizatION in Treatment of COMPLEX Lesion (PRECISION-COMPLEX)

Sponsor: Chonnam National University Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2022-11-01

Completion Date

2027-12-31

Last Updated

2025-04-23

Healthy Volunteers

Conditions

Coronary Artery Disease Angina Pectoris

Interventions

PROCEDURE

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).

PROCEDURE

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.

DEVICE

Drug-eluting stent

All patient will be received percutaneous coronary intervention with second generation drug-eluting stent.

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

Locations (4)

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