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Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System Clinical Study

NCT03284255 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 431

Last updated 2019-11-21

No results posted yet for this study

Summary

The Bioheart Randomized Controlled Trial is a prospective multicentred paralleled study, which will enroll 430 patients and randomized 1:1 to study group and control group. Aim to assess the efficacy and safety of Rapamycin Drug-Eluting Bioresorbable Coronary Stent System compare with XIENCE stent in the treatment of patients with up to two coronary lesions.

Conditions

Interventions

DEVICE

study group

study group in which patient will accept the treatment of Bioresorbable Coronary Stent

DEVICE

control group

control group in which patient will accept the treatment of Drug Eluting Stent of Abbott's XIENCE PRIME™ or XIENCE V®

Sponsors & Collaborators

  • CCRF Inc., Beijing, China

    collaborator INDUSTRY

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

    lead INDUSTRY

Principal Investigators

  • Shubin Qiao, professor · Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)

  • Bo Xu, professor · Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-09-11
Primary Completion
2020-08-30
Completion
2024-08-30

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 NCT03284255 on ClinicalTrials.gov