Efficacy and Safety of Zotarolimus-eluting Stent Overexpansion With OCT

NCT05340361 | Active Not Recruiting DMC

• 1 other identifier: 9-2021-0176
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Optical Coherence Tomography; Stent; Coronary Artery Disease

Keywords

coronary artery disease; optical coherence tomography; stenting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Stent strut fracture

  Through procedure completion, up to 24 hours

• Absolute average stent diameter (mm) in the maximal stent expansion site

  Through procedure completion, up to 24 hours

• Grade of polymer damage assessed by electron microscope

  Through procedure completion, up to 1-month

Study Arms (1)

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; Device: Optical coherence tomography-guided Onyx family stent expansion

Interventions

Optical coherence tomography-guided percutaneous coronary intervention 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.

Also known as: Zotarolimus-eluting stent (Onyx family stent, Medtronic, Santa Rosa, CA, USA)

In vivo

Optical coherence tomography-guided Onyx family stent expansion 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

In vivo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead
• Severance Hospital: collaborator
• Medtronic: collaborator

Study Sites (1)

Yongin Severance Hospital

Yongin, Gyeonggi-do, 16995, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 22, 2022
• Study Start: March 23, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)