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

Not Applicable

Recruiting

• Conditions: Angina Pectoris; Coronary Artery Disease
• Interventions: Procedure: OCT-guided PCI; Procedure: Angiography-guided PCI; Device: Drug-eluting stent

• Registration Number: NCT05493904
• Lead Sponsor: Chonnam National University Hospital

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.

Study Timeline

• Study First Submitted: 2022-08-07
• Study First Submitted QC: 2022-08-07
• Study First Posted: 2022-08-09
• Study Start: 2022-11-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18
• Primary Completion: 2024-08-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Angiography-guided PCI arm	Drug-eluting stent	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.
OCT-guided PCI arm	Drug-eluting stent	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.
OCT-guided PCI arm	OCT-guided PCI	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.
Angiography-guided PCI arm	Angiography-guided PCI	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.

Primary Outcome Measures

Name	Time	Method
Suboptimal post-PCI physiological results	Immediate after the index procedure	Proportion of patients with a final post-interventional fractional flow reserve \<0.85

Secondary Outcome Measures

Name	Time	Method
Rate of target vessel failure (TVF)	2-Year after the index procedure	a composite of cardiac death, target-vessel myocardial infarction (MI), and target-vessel revascularization (TVR)
Rate of all-cause death	2-Year after the index procedure	death from any-cause
Rate of cardiac death	2-Year after the index procedure	death from cardiac-cause
Rate of target vessel MI without periprocedural MI	2-Year after the index procedure	Myocardial infarction without periprocedural myocardial infarction
Rate of target vessel MI with periprocedural MI	2-Year after the index procedure	Myocardial infarction with periprocedural myocardial infarction
Rate of target lesion revascularization (TLR)	2-Year after the index procedure	ischemia-driven or all
Rate of target vessel revascularization (TVR)	2-Year after the index procedure	ischemia-driven or all
Rate of any MI	2-Year after the index procedure	any myocardial infarction
Rate of any revascularization	2-Year after the index procedure	ischemia-driven or all
Rate of stent thrombosis	2-Year after the index procedure	definite, probable, or possible
FFR gain between pre- and post-interventional stages	Immediate after the index procedure	\[Post-interventional fractional flow reserve value\] - \[Pre-interventional fractional flow reserve value\]
Post-interventional non-hyperemic pressure ratios	Immediate after the index procedure	Values of post-PCI non-hyperemic pressure ratios
Trans-stent FFR gradient	Immediate after the index procedure	FFR gradient across the stent (ΔFFRstent)

Trial Locations

Locations (6)

Chung-Ang University Gwangmyeong Hospital; 🇰🇷 Gwangmyeong, Korea, Republic of

Keimyung University Dongsan Hospital; 🇰🇷 Daegu, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Jeju National University Hospital; 🇰🇷 Jeju, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of