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

NAActive, not recruitingINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

November 1, 2022

Primary Completion Date

December 5, 2024

Study Completion Date

December 31, 2027

Conditions
Coronary Artery DiseaseAngina 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.

Trial Locations (4)

61469

Chonnam National University Hospital, Gwangju

Unknown

Chung-Ang University Gwangmyeong Hospital, Gwangmyeong

Samsung Medical Center, Seoul

Seoul National University Hospital, Seoul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Abbott Medical Devices

INDUSTRY

lead

Chonnam National University Hospital

OTHER