Efficacy and Safety of Zotarolimus-eluting Stent Overexpansion With OCT (ONYSOVER)

In vivO Study of assessmeNt for Efficacy and safetY of Zotarolimus-eluting Stent OVERexpansion With Optical Coherence Tomography (ONYSOVER Trial)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Optical Coherence Tomography; Stent
• Intervention / Treatment: Device: Optical coherence tomography-guided percutaneous coronary intervention; Device: Optical coherence tomography-guided Onyx family stent expansion

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do
    • Yongin, Gyeonggi-do, South Korea, 16995
      • Yongin Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with IHD had a discrepancy between proximal and distal reference vessels requiring stent implantation and considering stent overexpansion will be recruited.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

In vivo; 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.

Device: Optical coherence tomography-guided percutaneous coronary intervention; OCT examination is performed using a frequency-domain OCT system (C7 Dragonfly OPTIS 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.; Other Names: Zotarolimus-eluting stent (Onyx family stent, Medtronic, Santa Rosa, CA, USA); Device: Optical coherence tomography-guided Onyx family stent expansion; Expansion of 2.25, 3.0, and 4.0 mm Onyx family stent@ nominal pressure; OCT pullback; Expansion with over 0.5mm sized non-compliant balloon of each stent; OCT pullback; Expansion with over 1.0mm sized non-compliant balloon of each stent; OCT pullback; Expansion with over 1.25~1.5mm sized non-compliant balloon of each stent; OCT pullback; Evaluation of polymer status with overexpansion assessed by an electric microscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal stent overexpansion (%)	defines as the ratio of the maximal stent diameter to each diameter of stent	Through procedure completion, up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent strut fracture	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)	Through procedure completion, up to 24 hours
Absolute average stent diameter (mm) in the maximal stent expansion site	Absolute average stent diameter (mm) in the maximal stent expansion site ((In in vivo and in vitro groups)	Through procedure completion, up to 24 hours
Grade of polymer damage assessed by electron microscope	Grade of polymer damage assessed by electron microscope (In in vitro group)	Through procedure completion, up to 1-month

Collaborators and Investigators

• Sponsor: Yonsei University
• Collaborators: Medtronic; Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: April 17, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: coronary artery disease; optical coherence tomography; stenting
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 9-2021-0176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I'll share the IPD if other researchers have good reason.

Drug and device information, study documents

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