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

NCT ID: NCT05493904

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2027-12-31

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.

Detailed Description

There has been ample evidence of the role of intracoronary imaging for optimizing the stent, especially among the patients with complex coronary lesions. Intracoronary imaging can be used during the entire process of percutaneous coronary intervention (PCI), from pre-PCI to post-PCI stages. Notably, approximately 15-20% of patients who underwent angiographically successful PCI showed significant stent underexpansion, malapposition, intra-stent thrombus formation, and edge dissection on intracoronary imaging studies, including optical coherence tomography (OCT).

Meanwhile, the role of pre-interventional fractional flow reserve (FFR) measurement has been well established and recommended by recent guideline. However, although previous studies evaluated the efficacy and safety of FFR-guided decision-making followed by angiographic stent implantation, they did not evaluate functionally optimized revascularization. Actually, the vessels with low post-PCI FFR had substantial proportions of suboptimized stented (underexpansion and acute malapposition) and residual disease in non-stented segments. Furthermore, several large observational studies have suggested that suboptimal physiologic results after PCI is associated with an increased risk of clinical events. Previously, the DOCTORS trial found out that OCT-guided PCI was associated with higher post-PCI FFR than angiography-guided PCI (0.94±0.04 vs. 0.92±0.05, P=0.005).

Therefore, OCT can be a useful tool for acquiring functional optimal results after stent implantation. This synergic effect between OCT and post-PCI FFR can be maximized when the investigators perform PCI for complex lesions. This study sought to evaluate compare post-interventional FFR value between OCT-guided and angiography-guided strategy for treatment of complex coronary lesion.

Conditions

Coronary Artery Disease; Angina Pectoris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OCT-guided PCI arm

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.

Group Type: ACTIVE_COMPARATOR

OCT-guided PCI

Intervention Type: 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).

Drug-eluting stent

Intervention Type: DEVICE

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

Angiography-guided PCI arm

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.

Group Type: ACTIVE_COMPARATOR

Angiography-guided PCI

Intervention Type: 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.

Drug-eluting stent

Intervention Type: DEVICE

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

Interventions

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).

Intervention Type: 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.

Intervention Type: PROCEDURE

Drug-eluting stent

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Chonnam National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seung Hun Lee

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Youngkeun Ahn, MD, PhD

Role: STUDY_CHAIR

Chonnam National University Hospital

Locations

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

Countries

South Korea

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CNUH-2022-283

Identifier Type: -

Identifier Source: org_study_id