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Assessment of Cutting-Balloon Angioplasty With Everolimus-Eluting Stent(EES) in the Treatment of Coronary Calcified Lesion(CCL) Guided by Intravascular Ultrasonography(IVUS)

NCT06177808 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-01-03

No results posted yet for this study

Summary

The study seeks to address the clinical question of how effectively a novel cutting balloon (Wolverine™) can modify calcified lesions for stent implantation in comparison with a non-compliant (NC) balloon, particularly when used alongside a bioabsorbable polymer-coated everolimus-eluting coronary stent (Synergy™).

Most previous researches on cutting balloons focused on only severe calcifications and had limitations such as small sample sizes with retrospective designs, emphasizing on short-term imaging outcomes. This study differs by including mild to severe calcifications and evaluating long-term clinical outcomes, intraprocedural factors, and operator convenience. It aims to provide evidence that could potentially expand the indications for cutting balloon use and inform insurance coverage policies.

The objective of the study is to test the safety and efficacy of the cutting balloon in preparing calcified coronary lesions for stent insertion compared to conventional methods.

Conditions

Interventions

DEVICE

Wolverine cutting balloon

As an intervention method for calcified coronary lesion modification, intervention group will undergo PCI after using the Wolverine cutting balloon for calcium modification.

DEVICE

Non-compliant balloon

As an intervention method for calcified coronary lesion modification, intervention group will undergo PCI after using the Non-compliant balloon for calcium modification.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Eulji University

    collaborator OTHER

  • The Catholic University of Korea

    collaborator OTHER

  • Hanil General Hospital, Korea

    collaborator UNKNOWN

  • Soonchunhyang University Hospital

    lead OTHER

Principal Investigators

  • Jon Suh, PhD · Soonchunhyang University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06177808 on ClinicalTrials.gov