Efficacy and Safety of Zotarolimus-eluting Stent Overexpansion With OCT

NCT ID: NCT05340361

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2026-12-31

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.

Conditions

Coronary Artery Disease; Optical Coherence Tomography; Stent

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Optical coherence tomography-guided percutaneous coronary intervention

Intervention Type: DEVICE

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.

Optical coherence tomography-guided Onyx family stent expansion

Intervention Type: DEVICE

1. Expansion of 2.25, 3.0, and 4.0 mm Onyx family stent@ nominal pressure

2. OCT pullback

3. Expansion with over 0.5mm sized non-compliant balloon of each stent

4. OCT pullback

5. Expansion with over 1.0mm sized non-compliant balloon of each stent

6. OCT pullback

7. Expansion with over 1.25~1.5mm sized non-compliant balloon of each stent

8. OCT pullback

9. Evaluation of polymer status with overexpansion assessed by an electric microscope

Interventions

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.

Intervention Type: DEVICE

Optical coherence tomography-guided Onyx family stent expansion

1. Expansion of 2.25, 3.0, and 4.0 mm Onyx family stent@ nominal pressure

2. OCT pullback

3. Expansion with over 0.5mm sized non-compliant balloon of each stent

4. OCT pullback

5. Expansion with over 1.0mm sized non-compliant balloon of each stent

6. OCT pullback

7. Expansion with over 1.25~1.5mm sized non-compliant balloon of each stent

8. OCT pullback

9. Evaluation of polymer status with overexpansion assessed by an electric microscope

Intervention Type: DEVICE

Other Intervention Names

Zotarolimus-eluting stent (Onyx family stent, Medtronic, Santa Rosa, CA, USA)

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Severance Hospital

OTHER

Sponsor Role: collaborator

Medtronic

INDUSTRY

Sponsor Role: collaborator

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Yongcheol Kim

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yongin Severance Hospital

Yongin, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Yongcheol Kim, MD, PhD

Role: CONTACT

yongcheol@yuhs.ac

+82-031-5189-8967

Ji Woong Roh, MD, PhD

Role: CONTACT

NOMGALDA@yuhs.ac

+82-031-5189-8792

Facility Contacts

Miju Shin

Role: primary

mijushin@yuhs.ac

+82-031-5189-8893

Other Identifiers

9-2021-0176

Identifier Type: -

Identifier Source: org_study_id