NCT01412164

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
730

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

March 17, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

August 5, 2011

Results QC Date

February 19, 2016

Last Update Submit

August 12, 2019

Conditions

Coronary Artery Disease

Keywords

DESCADFIREHAWKMicroPortPCI

Outcome Measures

Primary Outcomes (1)

  • TLF (Target Lesion Failure) Rate

    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 Outcomes (7)

  • Stent Implantation Success Rate (SIS Rate)

    immediately after the procedure

  • Patient-related Cardiovascular Clinical Composite Endpoints

    1 years after index PCI

  • Patient-related Cardiovascular Clinical Composite Endpoints

    3 years after index PCI

  • Patient-related Cardiovascular Clinical Composite Endpoints

    5 years after index PCI

  • TLF (Target Lesion Failure)

    1 years after index PCI

  • +2 more secondary outcomes

Study Arms (1)

Firehawk

EXPERIMENTAL

Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD

Device: FIREHAWK biodegradable polymer rapamycin-eluting stent

Interventions

FIREHAWK biodegradable polymer rapamycin-eluting stentDEVICE

DES PCI for CAD

Firehawk

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, China

Location

Related Publications (1)

  • Gao Z, Zhang R, Xu B, Yang Y, Ma C, Li H, Chen S, Han Y, Yuan Z, Lansky AJ, Guan C, Leon MB, Gao R; TARGET Investigators. Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: two-year results from a prospective patient-level pooled analysis of TARGET trials. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:734-43. doi: 10.1002/ccd.25861. Epub 2015 Feb 19.

    PMID: 25678281DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Results Point of Contact

Title
Kefei Li
Organization
Shanghai Microport Medical (Group) Co.,Ltd.
kfli@microport.com
+86-21-38954600×6700

Study Officials

  • Runlin Gao, M.D., Prof.

    Fu Wai Hospital, Beijing, China

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2011

First Posted

August 9, 2011

Study Start

August 1, 2011

Primary Completion

February 1, 2013

Study Completion

January 1, 2017

Last Updated

August 26, 2019

Results First Posted

March 17, 2016

Record last verified: 2019-08

Locations

CN(1)