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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05493904
• Other study ID #: CNUH-2022-283
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Chonnam National University Hospital
• Contact: Youngkeun Ahn, MD, PhD
• Phone: +82-62-220-4764
• Email: cecilyk[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 31, 2026
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease

Intervention

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).
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Chung-Ang University Gwangmyeong Hospital	Gwangmyeong
Korea, Republic of	Jeju National University Hospital	Jeju
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Chonnam National University Hospital	Abbott Medical Devices

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Total procedure time	Total procedure time	Immediate after the index procedure
Other	Total amount of contrast dose	Total amount of contrast dose	Immediate after the index procedure
Other	Total fluoroscopy time	Total fluoroscopy time	Immediate after the index procedure
Other	Total amount of radiation dose	Total amount of radiation dose	Immediate after the index procedure
Primary	Suboptimal post-PCI physiological results	Proportion of patients with a final post-interventional fractional flow reserve <0.85	Immediate after the index procedure
Secondary	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
Secondary	Rate of all-cause death	death from any-cause	2-Year after the index procedure
Secondary	Rate of cardiac death	death from cardiac-cause	2-Year after the index procedure
Secondary	Rate of target vessel MI without periprocedural MI	Myocardial infarction without periprocedural myocardial infarction	2-Year after the index procedure
Secondary	Rate of target vessel MI with periprocedural MI	Myocardial infarction with periprocedural myocardial infarction	2-Year after the index procedure
Secondary	Rate of target lesion revascularization (TLR)	ischemia-driven or all	2-Year after the index procedure
Secondary	Rate of target vessel revascularization (TVR)	ischemia-driven or all	2-Year after the index procedure
Secondary	Rate of any MI	any myocardial infarction	2-Year after the index procedure
Secondary	Rate of any revascularization	ischemia-driven or all	2-Year after the index procedure
Secondary	Rate of stent thrombosis	definite, probable, or possible	2-Year after the index procedure
Secondary	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
Secondary	Trans-stent FFR gradient	FFR gradient across the stent (?FFRstent)	Immediate after the index procedure
Secondary	Post-interventional non-hyperemic pressure ratios	Values of post-PCI non-hyperemic pressure ratios	Immediate after the index procedure