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Firehawk™ Coronary Stent System in the Treatment of Coronary Chronic Total Occlusion Lesion(s)

NCT03040934 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2020-01-10

No results posted yet for this study

Summary

This study is a prospective, multi-center, open-label, randomized controlled clinical trial,aims to assess the safety and effectiveness of the Firehawk™ sirolimus target-eluting coronary stent system with abluminal grooves containing a biodegradable polymer (Firehawk™) comparing the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with total coronary occlusion lesion(s).

Conditions

  • Drug-Eluting Stents
  • Percutaneous Coronary Intervention
  • Tomography, Optical Coherence

Interventions

DEVICE

Firehawk sirolimus target eluting coronary stent system

98 subjects will be enrolled to receive a test device of Firehawk sirolimus target eluting coronary stent system

DEVICE

XIENCE Everolimus-Eluting Coronary Stent System

98 subjects will be enrolled to receive a control device of XIENCE Everolimus-Eluting Coronary Stent System

Sponsors & Collaborators

  • Shanghai MicroPort Medical (Group) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yaling Han, MD · The General Hospital of Shenyang Military

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-10
Primary Completion
2019-09-16
Completion
2023-10-31

Countries

  • China

Study Locations

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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 NCT03040934 on ClinicalTrials.gov