Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)

August 12, 2019 updated by: Shanghai MicroPort Medical (Group) Co., Ltd.

A Prospective Multicenter Single-Arm Observational Registry Study Assessing the Safety and Efficacy of FIREHAWK Biodegradable Polymer Target-release Rapamycin-eluting Stent for the Treatment of Coronary Artery Disease: TARGET II

The study aims to further assess the safety, efficacy and the performance of its delivery system of FIREHAWK rapamycin-eluting stent up to five years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective open-labeled, multi-center, single-arm observational registry study. Approximately 1,100 subjects will be enrolled to evaluate the TLF as the primary endpoint at 12-month. Also, the study will follow up those subjects up to 5 years as the secondary endpoints.

Study Type

Interventional

Enrollment (Actual)

730

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Fuwai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-75, male or unpregnant women
  • Evidence of non-symptomatic ischemia, stable or non-stable angina or past MI
  • Native coronary artery target lesion
  • Target lesion length <=60mm, target lesion vessel diameter 2.25mm-4.0mm
  • Target lesion diameter stenosis>=70%
  • For each target lesion, Firehawk stent implantation only
  • Understand the study purpose, willing to participate and sign the letter of consent
  • Acceptance of clinical follow-up

Exclusion Criteria:

  • Acute MI within 72 hours
  • Unprotected LM and intervention-required three-vessel lesions
  • Calcified lesion failed in pre-dilation and twisted lesion
  • Bridge vessel lesion
  • Any stent implanted within one year
  • Severe heart failure (HYHA>=III) or LVEF<40%
  • Renal deficiency, blood creatinine > 2.0mg/dl
  • Bleeding tendency
  • Allergic to aspirin, clopidogrel, ticlopidine, dye, rapamycin and metal
  • Life expectation <12 months
  • History of not achieving study finish
  • No compliances to the protocol
  • Heart implantation subjects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Firehawk
Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD
Device: FIREHAWK biodegradable polymer rapamycin-eluting stent
DES PCI for CAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TLF (Target Lesion Failure) Rate
Time Frame: 12 months after index procedure
Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR
12 months after index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent Implantation Success Rate (SIS Rate)
Time Frame: immediately after the procedure
Stent implantation success (SIS) means participant successfully implanted stent, defined as residual stenosis of the lesion less than 30% and TIMI bloodflow Grade III
immediately after the procedure
Patient-related Cardiovascular Clinical Composite Endpoints
Time Frame: 1 years after index PCI
Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.
1 years after index PCI
Patient-related Cardiovascular Clinical Composite Endpoints
Time Frame: 3 years after index PCI
Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.
3 years after index PCI
Patient-related Cardiovascular Clinical Composite Endpoints
Time Frame: 5 years after index PCI
Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.
5 years after index PCI
TLF (Target Lesion Failure)
Time Frame: 1 years after index PCI
Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR
1 years after index PCI
TLF (Target Lesion Failure)
Time Frame: 3 years after index PCI
Participants with the determination of TLF, TLF is the composite of cardiac death, target vessel MI and clinically driven TLR
3 years after index PCI
TLF (Target Lesion Failure)
Time Frame: 5 years after index PCI
Participants with the determination of TLF. TLF is the composite of cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure
5 years after index PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai MicroPort Medical (Group) Co., Ltd.

Investigators

  • Principal Investigator: Runlin Gao, M.D., Prof., Fu Wai Hospital, Beijing, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

August 5, 2011

First Submitted That Met QC Criteria

August 8, 2011

First Posted (Estimate)

August 9, 2011

Study Record Updates

Last Update Posted (Actual)

August 26, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TARGET II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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