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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Angina Pectoris
• Intervention / Treatment: Procedure: OCT-guided PCI; Device: Drug-eluting stent; Procedure: Angiography-guided PCI

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 Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youngkeun Ahn, MD, PhD; Phone Number: +82-62-220-4764; Email: cecilyk@hanmail.net
• Study Contact Backup: Name: Seung Hun Lee, MD, PhD; Phone Number: +82-10-6413-7449; Email: lsh8602@naver.com

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Not yet recruiting
    • Keimyung University Dongsan Hospital
    • Contact: Chang-Wook Nam, MD, PhD; Email: namcwcv@gmail.com
    • Principal Investigator: Chang-Wook Nam, MD, PhD
  • Gwangju, Korea, Republic of, 61469
    • Recruiting
    • Chonnam National University Hospital
    • Contact: Youngkeun Ahn, MD, PhD; Phone Number: 82-62-220-5778; Email: cecilyk@hanmail.net
    • Principal Investigator: Youngkeun Ahn, MD, PhD
    • Sub-Investigator: Seung Hun Lee, MD, PhD
    • Contact: Seung Hun Lee, MD, PhD; Phone Number: 82-62-220-4246; Email: lsh8602@naver.com
    • Sub-Investigator: Min Chul Kim, MD, PhD
    • Sub-Investigator: Joon Ho Ahn, MD, PhD
    • Sub-Investigator: Young Joon Hong, MD, PhD
  • Gwangmyeong, Korea, Republic of
    • Not yet recruiting
    • Chung-Ang University Gwangmyeong Hospital
    • Contact: Sang Yeob Lee, MD, PhD; Email: louisahj@gmail.com
    • Principal Investigator: Sang Yeob Lee, MD, PhD
  • Jeju, Korea, Republic of
    • Not yet recruiting
    • Jeju National University Hospital
    • Contact: Song Yi Kim, MD, PhD; Email: ttoromom@jejunu.ac.kr
    • Principal Investigator: Song Yi Kim, MD, PhD
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Bon-Kwon Koo, MD, PhD; Email: bkkoo@snu.ac.kr
    • Sub-Investigator: Doyeon Hwang, MD
    • Principal Investigator: Bon-Kwon Koo, MD, PhD
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Contact: Joo Myung Lee, MD, PhD; Email: drone80@hanmail.net
    • Sub-Investigator: Ki Hong Choi, MD, PhD
    • Principal Investigator: Joo Myung Lee, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Device: Drug-eluting stent; All patient will be received percutaneous coronary intervention with second generation drug-eluting stent.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suboptimal post-PCI physiological results	Proportion of patients with a final post-interventional fractional flow reserve <0.85	Immediate after the index procedure

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chonnam National University Hospital
• Collaborators: Abbott Medical Devices
• Investigators: Study Chair: Youngkeun Ahn, MD, PhD, Chonnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 7, 2022
• First Submitted That Met QC Criteria: August 7, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Optical Coherence Tomography; Fractional Flow Reserve; Intravascular Imaging; Complex Lesion
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Chest Pain; Coronary Artery Disease; Angina Pectoris
• Other Study ID Numbers: CNUH-2022-283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
• IPD Sharing Time Frame: 1 year after study completion
• IPD Sharing Access Criteria: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No