NCT04179045

A Registry Trial of The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System

A Registry Trial of the Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in Patients With Coronary Artery Disease: BIOHEART Ⅲ

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 785 (estimated)
• Sponsor: Shanghai Bio-heart Biological Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multi-center single arm registry trial, planning to enroll 785 subjects. All subjects will receive clinical follow-up at 1 month, 6 month, 9 month and 1, 2, 3, 4, 5 year after index procedure. The primary endpoint will be target lesion failure (TLF) at 1 year after index procedure,which will be analyzed to evaluate the efficacy and safety of the device.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System	Subjects enrolled will be treated with Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-07-01
• Completion: 2026-07-01
• First posted: 2019-11-26
• Last updated: 2021-02-26

Locations

5 sites across 1 country: China