MedTrace Logo

A Clinical Trial to Evaluate the Safety and Efficacy of IBS Angel in Patients With Pulmonary Artery Stenosis

NCT04973540 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2021-11-19

No results posted yet for this study

Summary

This is a prospective, multi-center, single-arm clinical trial to evaluate the safety and efficacy of Iron Bioresorbable Scaffold System (IBS Angel) in patients with pulmonary artery stenosis.

Conditions

  • Pulmonary Artery Stenosis

Interventions

DEVICE

Iron Bioresorbable Scaffold System (IBS Angel)

Subjects in this arm will be implanted with IBS Angel.

Sponsors & Collaborators

  • Biotyx Medical (Shenzhen) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-13
Primary Completion
2024-07-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

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 NCT04973540 on ClinicalTrials.gov