Coronary Artery DiseaseNCT01196819

Randomized MicroPort's Firehawk DES Versus Xience V: TARGET I Trial

A study testing Firehawk and Xience V in people with Coronary Artery Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort of its safety, efficacy and delivery system in treating CAD. 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 and Xience V
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 458 participants
Where: 1 siteChina
Study dates: Sep 2010to Dec 2016
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 women who are not pregnant
Evidence of non-symptomatic ischemia, stable or non-stable angina or past heart attack cases
Target lesion is primary, single artery and single lesion of coronary artery
Target lesion vessel length ≤24mm, diameter 2.25mm-4.0mm
Lesion diameter stenosis ≥70%
Candidates understand the study, willing to sign Consent of Agreement and to willing to accept follow-up For long lesion group, at least one target lesion length ≥28mm，diameter 2.5mm-4.0mm, and one lesion needs to implant 33mm 0r 38mm long stent

Who cannot join

Acute heart attack within one week
Chronic complete stenosis (TIMI 0), left main lesion, three branches need to treat, branch vessel diameter ≤2.5mm and bypass lesion
Calcified lesion failed in pre-dilation and twisted lesion
In-stent restenosis
Stent implanted within one year
Severe heart failure (NYHA above III) or left ventricle EF <40%

Show all 19Show fewer

Renal function damage, blood creatinine >2.0mg/dl
Bleeding risk; allergic to drugs and agents used in procedure/treatment
Life expectation < 12 months
No compliances to the protocol
Heart implantation cases
Pre-specified OCT inclusion/exclusion criteria:
Patients underwent 9-month angio F/U
No binary restenosis at 9-month
LLL between -0.01~0.2mm
No mix-implanted stent
No more than one bail-out stent
No TLR occurred at 3 years after PCI
The target vessel able to deliver the OCT catheter

Trial locations and contacts

1 site in 1 country.

China1 site

Fuwai Hospital
Beijing, 100037

Other trials in China

About this study

Official title: A Prospective Multi-center Randomized Trial Assessing the Safety and Effectiveness of Biodegradable Polymer Target Release Rapamycin-Eluting STent vs. XIENCE V Everolimus-Eluting Stent for the Treatment of Coronary Artery Disease

The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort of its safety, efficacy and delivery system in treating CAD.

Read the detailed description

The primary endpoint is in-stent late lumen loss after 9 months of the stent implantation. The secondary endpoint is in-stent percent diameter stenosis.This study is based on non-inferior assumption (vs. Xience V), requiring both endpoints reach statistical significance. Prespecified OCT follow-up is planned at 3-Year after index procedure at 3 chosen hospitals.

Conditions: Coronary Artery Disease
Being tested: Firehawk, Xience V
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.

FirehawkDevice
Implantation of Firehawk drug eluting stent
Xience VDevice
Implantation of Xience V drug eluting stent

Study groups in NCT01196819
Study group	Role	What they receive
Xience V	Active comparator	Implantation of Xience V drug eluting stent Receives: Device: Xience V
Firehawk	Experimental	Implantation of Firehawk drug eluting stent Receives: Device: Firehawk

What is being measured

The primary outcome is the main question the study is designed to answer.

9 Months In-stent Late Lumen Loss
To observe in-stent late lumen loss after 9 months of stent implantation It means the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure
Measured: 9 months

Secondary outcomes (7)

9 Months In-stent Diameter Stenosis
the in-stent diameter stenosis 9 months post-procedure
Measured: 9 months
Target Lesion Failure(TLF) Rate
Percentage of participants with the determination of TLF. TLF is the composite of sudden cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Measured: 1 years after index PCI
TLF(Target Lumen Failure) Rate
percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.
Measured: 3 years after index PCI (Percutaneous Coronary Intervention)
TLF(Target Lumen Failure)
percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.
Measured: 5 years after index PCI
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
Measured: 1 years after index PCI
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
Measured: 3 years after index PCI
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
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.

Sep 2010Dec 2016

First posted8 Sep 2010 (estimated)
Study startSep 2010
Primary completionMay 2012
Study completionDec 2016

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 (3)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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 458 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01196819
Sponsor's protocol ID: Target I
Status last verified: Jul 2019
First submitted: 6 Sep 2010
Last updated: 30 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Li CJ, Xu B, Guan CD, Gao RL; TARGETⅠTrial Investigators. [Long term safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of coronary de novo lesions]. Zhonghua Xin Xue Guan Bing Za Zhi. 2017 Nov 24;45(11):940-947. doi: 10.3760/cma.j.issn.0253-3758.2017.11.009. Chinese.
PubMed 29166720
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
Gao RL, Xu B, Lansky AJ, Yang YJ, Ma CS, Han YL, Chen SL, Li H, Zhang RY, Fu GS, Yuan ZY, Jiang H, Huo Y, Li W, Zhang YJ, Leon MB; TARGET I Investigators. A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the TARGET I trial. EuroIntervention. 2013 May 20;9(1):75-83. doi: 10.4244/EIJV9I1A12.
PubMed 23685298

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Multi-center Randomized Trial Assessing the Safety and Effectiveness of Biodegradable Polymer Target Release Rapamycin-Eluting STent vs. XIENCE V Everolimus-Eluting Stent for the Treatment of Coronary Artery Disease
ClinicalTrials.gov ID: NCT01196819
Acronym / sponsor ID: Target I
Conditions: Coronary Artery Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 458 participants (actual)
Lead sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.Industry (pharma, biotech, devices)
Study start: Sep 2010 (actual)
Primary completion: May 2012 (actual)
Study completion: Dec 2016 (actual)
First posted: 8 Sep 2010 (estimated)
Results: Posted 22 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort of its safety, efficacy and delivery system in treating CAD.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Xience V	Active comparator	Device: Xience VImplantation of Xience V drug eluting stent
Firehawk	Experimental	Device: FirehawkImplantation of Firehawk drug eluting stent

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age 18-75, male or women who are not pregnant
Evidence of non-symptomatic ischemia, stable or non-stable angina or past heart attack cases
Target lesion is primary, single artery and single lesion of coronary artery
Target lesion vessel length ≤24mm, diameter 2.25mm-4.0mm
Lesion diameter stenosis ≥70%

Key exclusion criteria (19 listed)

Acute heart attack within one week
Chronic complete stenosis (TIMI 0), left main lesion, three branches need to treat, branch vessel diameter ≤2.5mm and bypass lesion
Calcified lesion failed in pre-dilation and twisted lesion
In-stent restenosis
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
FirehawkImplantation of Firehawk drug eluting stent	Device	Firehawk
Xience VImplantation of Xience V drug eluting stent	Device	Xience V

Primary outcome

9 Months In-stent Late Lumen Loss
Time frame: 9 months
To observe in-stent late lumen loss after 9 months of stent implantation It means the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure

7 secondary outcomes

9 Months In-stent Diameter Stenosis
Time frame: 9 months
Target Lesion Failure(TLF) Rate
Time frame: 1 years after index PCI
TLF(Target Lumen Failure) Rate
Time frame: 3 years after index PCI (Percutaneous Coronary Intervention)
TLF(Target Lumen Failure)
Time frame: 5 years after index PCI
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
Time frame: 1 years after index PCI
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
Time frame: 3 years after index PCI
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
Time frame: 5 years after index PCI

Results and safety

Results posted to the registry on 22 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Xience V DES as Comparative Arm	231	225
MicroPort Firehawk DES	227	227

Primary outcome: 9 Months In-stent Late Lumen Loss

Time frame: 9 months. Mean (Standard Deviation). Unit: mm

Measure	Xience V DES as Comparative Arm n = 202	MicroPort Firehawk DES n = 199
Value	0.13 (0.18)	0.13 (0.24)

Xience V DES as Comparative Arm vs MicroPort Firehawk DES: Mean Difference (Final Values): 0.17 (95% CI 0 to 0.29), p = 0.94, ANCOVA

Population analysed: Angiographic follow-up at nine months was completed in 87.6% (199/227) of the Firehawk DES group and 87.4% (202/231) of the Xience V DES group.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Xience V DES as Comparative Arm	46 of 225 (20.4%)	0 of 225 (0%)	8 of 225
MicroPort Firehawk DES	28 of 227 (12.3%)	0 of 227 (0%)	7 of 227

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29166720Li CJ, Xu B, Guan CD, Gao RL; TARGETⅠTrial Investigators. [Long term safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of coronary de novo lesions]. Zhonghua Xin Xue Guan Bing Za Zhi. 2017 Nov 24;45(11):940-947. doi: 10.3760/cma.j.issn.0253-3758.2017.11.009. Chinese.
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.
Derived from this study: PubMed 23685298Gao RL, Xu B, Lansky AJ, Yang YJ, Ma CS, Han YL, Chen SL, Li H, Zhang RY, Fu GS, Yuan ZY, Jiang H, Huo Y, Li W, Zhang YJ, Leon MB; TARGET I Investigators. A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the TARGET I trial. EuroIntervention. 2013 May 20;9(1):75-83. doi: 10.4244/EIJV9I1A12.
Individual participant dataSharing planned: No

Related trials for Coronary Artery Disease

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RecruitingObservational study
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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, Pro & MD principal investigator

Fuwai 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 and Xience V 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 6 inclusion and 19 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 30 Jul 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 22 Feb 2018). 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?

9 Months In-stent Late Lumen Loss (time frame: 9 months). 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 NCT01196819, which also lists 3 linked publications.

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 30 Jul 2019; AzTrials last refreshed its copy on 31 Oct 2026.