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

Sponsor

Chonnam National University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05493904

Collaborator

Abbott Medical Devices (Industry)

320

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Angina Pectoris	Procedure: OCT-guided PCI Procedure: Angiography-guided PCI Device: Drug-eluting stent	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Impact of Optical Coherence Tomography-guided Versus Angiography-guided Stent Optimization on Post-Interventional Fractional Flow Reserve in Patients With Complex Coronary Artery Lesions

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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. 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). 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). Device: Drug-eluting stent All patient will be received percutaneous coronary intervention with second generation drug-eluting stent.
Active Comparator: 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.	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.

Arm

Intervention/Treatment

Active Comparator: 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.

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. 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). 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).

Device: Drug-eluting stent

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

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

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

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]
Trans-stent FFR gradient [Immediate after the index procedure]
FFR gradient across the stent (ΔFFRstent)
Post-interventional non-hyperemic pressure ratios [Immediate after the index procedure]
Values of post-PCI non-hyperemic pressure ratios

Other Outcome Measures

Incidence of contrast-induced nephropathy [48-72 hours after index procedure]
defined as an increase in serum creatinine of ≥0.5mg/dL or ≥25% from baseline after contrast agent exposure
Total procedure time [Immediate after the index procedure]
Total procedure time
Total amount of contrast dose [Immediate after the index procedure]
Total amount of contrast dose
Total fluoroscopy time [Immediate after the index procedure]
Total fluoroscopy time
Total amount of radiation dose [Immediate after the index procedure]
Total amount of radiation dose

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)
Left anterior descending (LAD), left circumflex artery (LCX), and right coronary artery (RCA) ostial lesion

Exclusion Criteria:

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