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ACTIVE NOT RECRUITING
NCT05206084
NA

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

Sponsor: Biotyx Medical (Shenzhen) Co., Ltd.

View on ClinicalTrials.gov

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).

Official title: A Prospective, Multi-Center, Single-Blinded, Randomized Trial of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System in Patients With Coronary Artery Disease: IRONMAN-II

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

518

Start Date

2022-03-10

Completion Date

2028-01

Last Updated

2025-12-10

Healthy Volunteers

No

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

Locations (1)

Fuwai Yunnan Cardiovascular Hospital

Kunming, China