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

NCT05493904 | Active Not Recruiting DMC

• 1 other identifier: CNUH-2022-283
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 4

Brief 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

Coronary Artery Disease; Angina Pectoris

Keywords

Percutaneous Coronary Intervention; Intravascular Imaging; Optical Coherence Tomography; Fractional Flow Reserve; Complex Lesion

Outcome Measures

Primary Outcomes (1)

• Suboptimal post-PCI physiological results

  Proportion of patients with a final post-interventional fractional flow reserve \<0.85

  Immediate after the index procedure

Secondary Outcomes (13)

• Rate of target vessel failure (TVF)

  2 years after last patient enrollment

• Rate of all-cause death

  2 years after last patient enrollment

• Rate of cardiac death

  2 years after last patient enrollment

• Rate of target vessel MI without periprocedural MI

  2 years after last patient enrollment

• Rate of target vessel MI with periprocedural MI

  2 years after last patient enrollment

Other Outcomes (5)

• Incidence of contrast-induced nephropathy

  48-72 hours after index procedure

• Total procedure time

  Immediate after the index procedure

• Total amount of contrast dose

  Immediate after the index procedure

Study Arms (2)

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.

Procedure: OCT-guided PCI; Device: Drug-eluting stent

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.

Procedure: Angiography-guided PCI; Device: Drug-eluting stent

Interventions

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. 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).

OCT-guided PCI arm

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.

Angiography-guided PCI arm

Drug-eluting stent DEVICE

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

Angiography-guided PCI arm; OCT-guided PCI arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 years old
• Patients with stable or unstable angina and complex coronary lesions\*
• Patients who were indicated revascularization
• Diameter stenosis \>90% by angiography
• Diameter stenosis with 50\~90% with pre-interventional FFR ≤0.80
• Patients who underwent implantation of 2nd generation drug-eluting stent
• Definitions of complex coronary lesions
• True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size
• Chronic total occlusion (≥3 months) as target lesion
• PCI for unprotected left main (LM) disease (LM os, body, distal LM bifurcation including non-true bifurcation)
• Long coronary lesions (implanted stent ≥38 mm in length)
• Multi-vessel PCI (≥2 major epicardial coronary arteries treated at one PCI session)
• Multiple stents needed (≥3 more stent per patient)
• In-stent restenosis lesion as target lesion
• Severely calcified lesion (encircling calcium in angiography)

You may not qualify if:

• Target lesions not amenable for PCI by operators' decision
• Cardiogenic shock (Killip class IV) at presentation
• Less than TIMI 3 flow of target vessel after index procedure
• Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Everolimus, Zotarolimus, Biolimus, or Sirolimus
• Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
• Renal insufficiency such that an additional contrast medium would be harmful for patient
• Recent ST-segment elevation myocardial infarction (STEMI)
• Inability to receive adenosine or nicorandil injection
• Pregnancy or breast feeding
• 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)
• Unwillingness or inability to comply with the procedures described in this protocol

Sponsors & Collaborators

• Chonnam National University Hospital: lead
• Abbott Medical Devices: collaborator

Study Sites (4)

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Youngkeun Ahn, MD, PhD

  Chonnam National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 9, 2022
• Study Start: November 1, 2022
• Primary Completion: December 5, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1 year after study completion
• Access Criteria: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Locations

KR (4)