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A Clinical Investigation to Evaluate the Safety and Efficacy of IBS in Patients With Coronary Artery Disease

NCT05206084 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 518

Last updated 2025-12-10

No results posted yet for this study

Summary

A prospective, multi-center, single-blinded, randomized trial to assess the safety and efficacy of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS) in treating patients with coronary artery disease compared to the Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE).

Conditions

Interventions

DEVICE

Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS)

Subjects in this arm will be treated with IBS

DEVICE

Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System

Subjects in this arm will be treated with XIENCE

Sponsors & Collaborators

  • Biotyx Medical (Shenzhen) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2024-12-29
Completion
2028-01-31

Countries

  • China

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 NCT05206084 on ClinicalTrials.gov