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

NCT04179045 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 785

Last updated 2021-02-26

No results posted yet for this study

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

Interventions

DEVICE

The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System

Subjects enrolled will be treated with Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent.

Sponsors & Collaborators

  • CCRF Inc., Beijing, China

    collaborator INDUSTRY

  • Shanghai Bio-heart Biological Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Guosheng Fu, Professor · Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-07-31
Completion
2026-07-31

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 NCT04179045 on ClinicalTrials.gov