Coronary Artery DiseaseNCT01412164
Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)
A study testing FIREHAWK biodegradable polymer rapamycin-eluting stent in people with Coronary Artery Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- FIREHAWK biodegradable polymer rapamycin-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 730 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- FIREHAWK biodegradable polymer rapamycin-eluting stent
- Keywords
- DES, CAD, FIREHAWK, MicroPort, PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIREHAWK biodegradable polymer rapamycin-eluting stentDevice
DES PCI for CAD
| Study group | Role | What they receive |
|---|---|---|
| Firehawk | Experimental | Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD Receives: Device: FIREHAWK biodegradable polymer rapamycin-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months after index procedure
Secondary outcomes (7)
Stent Implantation Success Rate (SIS Rate)
Stent implantation success (SIS) means participant successfully implanted stent, defined as residual stenosis of the lesion less than 30% and TIMI bloodflow Grade III
Measured: immediately after the procedure
Patient-related Cardiovascular Clinical Composite Endpoints
Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.
Measured: 1 years after index PCI
Patient-related Cardiovascular Clinical Composite Endpoints
Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.
Measured: 3 years after index PCI
Patient-related Cardiovascular Clinical Composite Endpoints
Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.
Measured: 5 years after index PCI
TLF (Target Lesion Failure)
Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR
Measured: 1 years after index PCI
TLF (Target Lesion Failure)
Participants with the determination of TLF, TLF is the composite of cardiac death, target vessel MI and clinically driven TLR
Measured: 3 years after index PCI
TLF (Target Lesion Failure)
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
Measured: 5 years after index PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2013
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Runlin Gao, M.D., Prof., Principal investigator, Fu Wai Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412164
- Sponsor's protocol ID
- TARGET II
- Status last verified
- Aug 2019
- First submitted
- 5 Aug 2011
- Last updated
- 26 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25678281
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01412164
- Acronym / sponsor ID
- TARGET II
- Conditions
- Coronary Artery Disease
- Keywords
- DES, CAD, FIREHAWK, MicroPort, PCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 730 participants (actual)
- Lead sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Aug 2011 (estimated)
- Results
- Posted 17 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Firehawk | Experimental | Device: FIREHAWK biodegradable polymer rapamycin-eluting stentUsing Firehawk biodegradable polymer rapamycin-eluting stent for CAD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIREHAWK biodegradable polymer rapamycin-eluting stentDES PCI for CAD | Device | Firehawk |
Primary outcome
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
7 secondary outcomes
Stent Implantation Success Rate (SIS Rate)
Time frame: immediately after the procedure
Patient-related Cardiovascular Clinical Composite Endpoints
Time frame: 1 years after index PCI
Patient-related Cardiovascular Clinical Composite Endpoints
Time frame: 3 years after index PCI
Patient-related Cardiovascular Clinical Composite Endpoints
Time frame: 5 years after index PCI
TLF (Target Lesion Failure)
Time frame: 1 years after index PCI
TLF (Target Lesion Failure)
Time frame: 3 years after index PCI
TLF (Target Lesion Failure)
Time frame: 5 years after index PCI
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25678281Gao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Runlin Gao, M.D., Prof. principal investigator
Fu Wai Hospital, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIREHAWK biodegradable polymer rapamycin-eluting stent in people with Coronary Artery Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TLF (Target Lesion Failure) Rate (time frame: 12 months after index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01412164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019.