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Dynamic Change of Coronary Artery Curvature

NCT04936191 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-01-07

No results posted yet for this study

Summary

The novolimus-eluting DynamX bioadaptor system is composed of 71 µm cobalt-chromium sinusoidal rings connected to each other axially by three S-links Each ring contains three uncaging elements that are positioned at equal distance in low stress regions of struts oriented in a helical configuration along the length of the bioadaptor which remain intact after uncaging. The uncaging elements consist of three separable junctions per ring held together by a 6 µm polymer coating that is resorbed over six months, allowing uncaging of the vessel and adaptive remodeling. Previous study showed the DynamX biodaptor is safe and effective treating in de novo coronary lesion. It also increased of vessel and device area while maintain in the mean lumen area after one year follow-up. However, the unchanging effect of Dynamx bioadaptor on coronary geometry change remained unknown. The present randomized control study is designed to investigate the differences of dynamic coronary artery geometry changes evaluated by coronary computed tomography angiography after DynamX Bioadaptor and permanent metallic DES implantation.

Conditions

Interventions

DEVICE

DynamX Bioadaptor

Patients received percutaneous coronary intervention in a similar way to a traditional DES. Patients first receive radial artery or femoral artery cannulation with anticoagulation during the intervention. All coronary angiograms are carefully measured by at least 2 orthographic views and performed under the same standard conditions. After adequate predilatation of the target lesion, the coronary stenting will be performed. All patients will receive a loading dose of acetylsalicylic acid and a P2Y12 inhibitor pre-procedure followed by dual antiplatelet therapy for at least 6 months.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Hsien-Li Kao, MD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-18
Primary Completion
2023-11-21
Completion
2024-12-31

Countries

  • Taiwan

Study Locations

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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 NCT04936191 on ClinicalTrials.gov