MedTrace Logo

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

NCT05493904 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2025-04-23

No results posted yet for this 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.

Conditions

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.

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Chonnam National University Hospital

    lead OTHER

Principal Investigators

  • Youngkeun Ahn, MD, PhD · Chonnam National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2024-12-05
Completion
2027-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05493904 on ClinicalTrials.gov