Efficacy and Safety of Zotarolimus-eluting Stent Overexpansion With OCT

Recruiting

• Conditions: Coronary Artery Disease; Optical Coherence Tomography; Stent
• Interventions: Device: Optical coherence tomography-guided percutaneous coronary intervention; Device: Optical coherence tomography-guided Onyx family stent expansion

• Registration Number: NCT05340361
• Lead Sponsor: Yonsei University

Brief Summary

Investigators aimed to evaluate efficacy and safety of expansion capacity of zotarolimus-eluting Stent assessed by optical coherence tomography (OCT) in vivo study.

Detailed Description

Single stent implantation (also called "provisional stenting") is currently the preferred technique for percutaneous coronary interventions on the majority of unprotected left main (LM) or non-LM bifurcations. During provisional stenting, proximal optimization technique (POT), proved to correct both the proximal main vessel (MV) malapposition and/or optimize the side branch (SB) ostium strut opening for proper wire re-crossing into the distal cell, might be crucial step and may warrant improved long-term clinical outcomes in the setting of major proximal and distal reference vessel size mismatch (like often in LM bifurcation or diffuse tapered long lesion).

Recently, second-generation drug-eluting stent (DES) implantation is recommended over BMS for PCI in patients with ischemic heart disease (IHD) due to superior efficacy and safety. However, percutaneous coronary intervention (PCI) with DES for lesion with the discrepancy of proximal and distal reference vessel size, such as LM or non-LM bifurcation lesion, diffuse tapered long lesion, and ectatic or aneurysmal coronary artery, is challenging due to stent optimization because expert consensus recommend that stent diameter is selected by distal reference diameter, which need stent overexpansion for POT.

OCT is a utility that can accurately measure reference vessel diameter and lesion length pre-PCI, which is useful for stent optimization by a suitable stent selection and pre- and post-interventional strategies. OCT also demonstrated higher sensitivity to detect stent malapposition, edge dissection, and tissue prolapsed than IVUS post-PCI. Thus, OCT-guided PCI can be helpful to optimize DES implantation in patients with dilated coronary arteries despite the potential limitation of depth penetration and attenuation images by thrombus.

Zotarolimus-eluting stent (Onyx family stent, Medtronic, Santa Rosa, CA, USA) was developed in response to the demand for stents with improved radiographic visibility. It has a novel thin strut composite wire stent platform that is covered with the same zotarolimus-eluting durable polymer coating as its predecessors. The metallic stent platform consists of a composite wire made from a dense platinum-iridium core, which makes the struts radiopaque, and an outer layer of cobalt-chromium alloy. The dense core also allows for reduced strut thickness, which might be associated with a decreased risk of stent thrombosis.

Onyx family stent has been labeled for maximum stent inner diameter by easy crowns platform (2.00-2.5 mm, 6.5 Crowns; 2.75-3.0 mm, 8.5 crowns; 3.5-4.0 mm, 9.5 crowns; 4.5-5.0 mm; 10.5 crowns). However, safety and efficacy of DES overexpansion is still concerned as safety of efficacy of there are limited data regarding Onyx family stent overexpansion in vivo.

This study aims to evaluate the safety and efficacy of Onyx family stent overexpansion for lesion with the discrepancy between proximal and distal reference vessel which need stent overexpansion for POT, assessed by OCT, providing high-resolution (10 µm) imaging which enables the detection of strut fracture, malapposition.

Study Timeline

• Study Start: 2022-03-23
• Study First Submitted: 2022-04-17
• Study First Submitted QC: 2022-04-17
• Study First Posted: 2022-04-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients, ≥19 years of age, who were diagnosed with IHD requiring stent implantation for lesion with size discrepancy between proximal and distal reference diameter over 1mm, such as tapered long lesion or bifurcation lesion, confirmed by OCT
• The decision to participate voluntarily in this study and the written consent of the patient

Exclusion Criteria

• Patients with hypersensitivity or contraindication to antiplatelet treatment
• Female of childbearing potential, who possibly plans to become pregnant any time after enrollment into this study.
• Patients with a life expectancy shorter than 1 year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
In vivo	Optical coherence tomography-guided percutaneous coronary intervention	OCT examination is performed using a frequency-domain OCT system (C7 DragonflyTM OPTISTM Imaging Catheter, Abbott Vascular, Santa Clara, CA, USA) with a 5.4 or 7.5 cm total pullback length according to a non-occlusive technique. The procedure is performed via radial or femoral access with a ≥6 Fr guiding catheter. The OCT catheter is advanced over the 0.014-inch PCI wire and the implanted stent was crossed after administration of intracoronary nitrates of 200 µg. For blood clearing, contrast media was injected through the guiding catheter with an automated power injector. The standard infusion rate was 4 mL/s for 4 seconds with 250 PSI. Follow-up OCT image acquisition was achieved with the same method. After post-PCI OCT, we evaluate the factor regarding post-PCI optimization target by European Expert Consensus.
In vivo	Optical coherence tomography-guided Onyx family stent expansion	OCT examination is performed using a frequency-domain OCT system (C7 DragonflyTM OPTISTM Imaging Catheter, Abbott Vascular, Santa Clara, CA, USA) with a 5.4 or 7.5 cm total pullback length according to a non-occlusive technique. The procedure is performed via radial or femoral access with a ≥6 Fr guiding catheter. The OCT catheter is advanced over the 0.014-inch PCI wire and the implanted stent was crossed after administration of intracoronary nitrates of 200 µg. For blood clearing, contrast media was injected through the guiding catheter with an automated power injector. The standard infusion rate was 4 mL/s for 4 seconds with 250 PSI. Follow-up OCT image acquisition was achieved with the same method. After post-PCI OCT, we evaluate the factor regarding post-PCI optimization target by European Expert Consensus.

Primary Outcome Measures

Name	Time	Method
Maximal stent overexpansion (%)	Through procedure completion, up to 24 hours	defines as the ratio of the maximal stent diameter to each diameter of stent

Secondary Outcome Measures

Name	Time	Method
Grade of polymer damage assessed by electron microscope	Through procedure completion, up to 1-month	Grade of polymer damage assessed by electron microscope (In in vitro group)
Absolute average stent diameter (mm) in the maximal stent expansion site	Through procedure completion, up to 24 hours	Absolute average stent diameter (mm) in the maximal stent expansion site ((In in vivo and in vitro groups)
Stent strut fracture	Through procedure completion, up to 24 hours	defines as none or fewer visible stent strut on the cross-sectional view by performing OCT within stented segments (In in vivo and in vitro groups)

Trial Locations

Locations (1)

Yongin Severance Hospital; 🇰🇷 Yongin, Gyeonggi-do, Korea, Republic of