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Coronary Artery DiseaseTARGET-IV_NANCT04562532

Firehawk Rapamycin Target Eluting Coronary Stent North American Trial

A study testing Microport Firehawk stent and 2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent) in people with Coronary Artery Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 57 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The aim of the TARGET-IV NA trial is to demonstrate the clinical non-inferiority of the Firehawk® rapamycin eluting stent system in comparison to currently approved 2nd generation DES for the treatment of subjects with ischemic heart disease (NSTEMI, recent STEMI (>24 hours from initial presentation and in whom enzyme… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Microport Firehawk stent and 2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,720 participants
Where
57 sitesin 5 countries
Study dates
17 Feb 2021to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Patient understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment.
  • Patients with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or a positive coronary physiology test (e.g. FFR≤0.80 or iFR<0.90 or rFR ≤ 0.89 must be present), NSTEMI, or recent STEMI (STEMI >24 hours and in whom enzyme levels have peaked). For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked.
  • Patient is willing to comply with all protocol-required follow-up evaluations.
  • Angiographic inclusion criteria:
  • Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.25 mm to ≤4.0 mm and up to 44 mm in length.
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  • The coronary anatomy is deemed likely to allow delivery of a study device to the target lesion(s).
  • Complex lesions are allowed including calcified lesions (lesion preparation is allowed and strongly recommended with current approved devices (e.g. scoring/cutting balloon and rotational/orbital atherectomy), multivessel disease, CTO,bifurcation lesions (except planned dual stent implantation), ostial lesions, tortuous lesions, and protected left main lesions.
  • Overlapping stents are allowed

Who cannot join

  • STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin) have not peaked.
  • PCI within the 24 hours preceding the baseline procedure.
  • History of stent thrombosis.
  • Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP.
  • Subject is intubated.
  • Known LVEF <30%.
Show all 31Show fewer
  • Subject has a known allergy to contrast (that cannot be adequately pre-medicated) and/or the trial stent system or any protocol-required concomitant medications or devices (e.g. cobalt chromium alloy, stainless steel, sirolimus, everolimus or structurally related compounds, polymer, any P2Y12 inhibitor, or aspirin).
  • Planned surgery within 6 months.
  • Subject has an indication for chronic oral anticoagulant treatment (with either vitamin K antagonists or novel anticoagulants - NOACs)
  • Calculated creatinine clearance <30 mL/min using Cockcroft-Gault equation (<40 mL/min for subjects participating in the angiographic follow-up sub-study).
  • Hemoglobin <10 g/dL.
  • Platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
  • White blood cell (WBC) count <3,000 cells/mm3.
  • Clinically significant liver disease.
  • Active peptic ulcer or active bleeding from any site.
  • Other serious medical illness with a life-expectancy < 24 months (e.g. cancer, severe heart failure, severe lung disease).
  • A planned procedure that may cause non-compliance with the protocol or confound data interpretation.
  • Participation in another investigational drug or device trial that has not yet reached its primary endpoint and that may interfere with protocol compliance or confound data interpretation (as per the opinion of the investigator); or intent to participate in another investigational drug or device trial within 12 months.
  • Intention to become pregnant within 12 months (women of child-bearing potential who are sexually active must agree to use contraceptives from the time of enrollment through 12 months post-procedure).
  • Pregnancy or nursing (women of child-bearing potential must have a pregnancy test within 7 days prior to the index procedure).
  • Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.).
  • Subject has received an organ transplant or is on a waiting list for an organ transplant.
  • Subject is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease (e.g., HIV). Corticosteroids are allowed.
  • Angiographic Exclusion Criteria:
  • Unprotected left main interventions
  • Bifurcation lesions with intended dual stent implantations
  • DES restenotic lesions
  • Prior PCI in the target vessel in the 12 months prior to enrollment
  • Any lesion in the target vessel that is likely to require PCI within 12 months
  • Stent lengths >36mm for diameters 2.0 mm and 2.25 mm (i.e., very long thin stents).
  • Lesion with intended ≥ 3 stent implantation

Trial locations and contacts

57 sites in 5 countries.

57 sites in 5 countries

United States44 sites

  • AnMed Health

    Anderson, South Carolina, 29621

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 13203

  • JFK Medical Center

    Atlantis, Florida, 33462

  • Eastern Maine Medical Center-Northern Light Cardiology

    Bangor, Maine, 04401

  • McLaren Bay

    Bay City, Michigan, 48708

  • Cardiology PC

    Birmingham, Alabama, 35211

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center, Inc.

    Boston, Massachusetts, 02215

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

  • CCC Research - Countryside

    Clearwater, Florida, 33756

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida, 33756

  • Boone Hospital Center

    Columbia, Missouri, 65201

  • Metropolitan Heart Vascular Institute

    Coon Rapids, Minnesota, 55433

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226

  • Atlanta Veterans Affairs Medical Center

    Decatur, Georgia, 30033

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Elkhart General Hospital

    Elkhart, Indiana, 46514

  • UPMC Hamot

    Erie, Pennsylvania, 16550

  • Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297

  • UPMC Harrisburg Hospital

    Harrisburg, Pennsylvania, 17104

  • St. Vincent Heart Center of Indiana

    Indianapolis, Indiana, 46260

  • St Dominic Hospital

    Jackson, Mississippi, 39216

  • Memorial Hospital Jacksonville

    Jacksonville, Florida, 32216

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Turkey Creek Medical Center

    Knoxville, Tennessee, 37934

  • Mayo Clinic Health System

    La Crosse, Wisconsin, 54601

  • UC San Diego School of Medicine

    La Jolla, California, 90903

  • McLaren Greater Lansing

    Lansing, Michigan, 48910

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Bryan Medical Center East

    Lincoln, Nebraska, 68506

  • Texas Tech University Health

    Lubbock, Texas, 79430

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Yale New Heaven Hospital

    New Haven, Connecticut, 06511

  • Columbia University Medical Center/NYPH

    New York, New York, 10032

  • McLaren Northern Michigan

    Petoskey, Michigan, 49770

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • NC Heart and Vascular Research

    Raleigh, North Carolina, 27607

  • Riverside Community Hospital

    Riverside, California, 92501

  • St. Francis Hospital & Heart Center

    Roslyn, New York, 11576

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105

  • Mercy Health St. Vincent Medical Center LLC

    Toledo, Ohio, 43608

  • East Texas Medical Center

    Tyler, Texas, 75701

Other trials in United States

Canada7 sites

  • University of Calgary- Foothills Medical Center

    Calgary, Alberta, T2W1S7

  • Montreal Heart Institute

    Montreal, Quebec, H1T1C8

  • CHUM

    Montreal, Quebec, H2X0A9

  • York PCI Group Inc

    Newmarket, Ontario, L3Y2P7

  • IUPQ

    Québec, Qebec, G1V4G5

  • CIUSSE de l'estrie CHUS

    Sherbrooke, Quebec, J1J3H5

  • St. Boniface Hospital Inc.

    Winnipeg, Manitoba, R2H2A6

Other trials in Canada

Denmark4 sites

  • Aarhus University Hospital

    Aarhus

  • Copenhagen University Hospital - Rigshospitalet

    Copenhagen

  • Odense University Hospital

    Odense

  • Roskilde University Hospital

    Roskilde

Other trials in Denmark

Belgium1 site

  • Onze Lieve Vrouw Hospital

    Aalst

Other trials in Belgium

Netherlands1 site

  • Radbout UMC

    Nijmegen

Other trials in Netherlands

About this study

Official title: Multicenter Randomized Assessment of the Firehawk™ Rapamycin TARGET Eluting Cobalt Chromium Coronary Stent System - North American Trial

The aim of the TARGET-IV NA trial is to demonstrate the clinical non-inferiority of the Firehawk® rapamycin eluting stent system in comparison to currently approved 2nd generation DES for the treatment of subjects with ischemic heart disease (NSTEMI, recent STEMI (>24 hours from initial presentation and in whom enzyme levels have peaked), unstable angina, and stable coronary disease), with atherosclerotic target lesion(s) in coronary arteries with visually estimated reference vessel diameters ≥2.25 mm and ≤4.0 mm.

Read the detailed description

TARGET-IV NA trial is a prospective, multicenter, 1:1 randomized (Firehawk® vs. 2nd generation DES), trial.

Sub studies:

Angiographic sub study: The first approximately 200 consecutive consenting patients will be enrolled in the angiographic substudy. Optical coherence tomography (OCT) substudy: The first approximately 50 consecutive consenting subjects will be enrolled in the OCT substudy.

Clinical follow-up will be performed at 30 days, 6 months, and 1, 2, 3, 4, and 5 years post randomization. First approximately 200 consecutive consenting patients will undergo planned angiographic follow-up at 13 months after enrollment, with first 50 of these patients also consented to undergo planned OCT at baseline and at 13 months following randomization.

Being tested
Microport Firehawk stent, 2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent)
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.

  • Microport Firehawk stentDevice

    Also called MicroPort Firehawk rapamycin target eluting stent

    MicroPort Firehawk biodegradable polymer rapamycin target eluting stent

  • 2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent)Device

    • Everolimus eluting stents (Xience family - Abbott Vascular, Promus family- Boston Scientific, Synergy - Boston Scientific)
    • Zotarolimus eluting stents (Resolute/Onyx family and Endeavor- Medtronic)
    • Sirolimus eluting stents (Orsiro- Biotronik)
Study groups in NCT04562532
Study groupRoleWhat they receive
Firehawk groupExperimentalParticipants implant Firehawk stent(s)
Receives: Device: Microport Firehawk stent
2nd generation DESActive comparatorParticipants implant Everolimus eluting stents (Xience family - Abbott Vascular, Promus family- Boston Scientific, Synergy - Boston Scientific), or Zotarolimus eluting stents (Resolute/Onyx family and Endeavor- Medtronic), or Sirolimus eluting stents (Orsiro- Biotronik)
Receives: Device: 2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent)

What is being measured

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

  1. Target Lesion Failure

    Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year

    Measured: 12 months

Secondary outcomes (15)

  1. In-stent late loss

    In-stent late loss at 13 months post-procedure as measured by quantitative coronary angiography (QCA)

    Measured: 13 months

  2. Neointimal thickness

    Neointimal thickness at 3 months measured by Optical Coherence Tomography (OCT)

    Measured: 13 months

  3. Target Lesion Failure

    Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated)

    Measured: 12 months and yearly thereafter until 5 years

  4. Target vessel failure

    Percentage of participants that had either cardiac death, target vessel-related MI*, or ischemia-driven target-vessel revascularization

    Measured: 12 months and yearly thereafter until 5 years

  5. Major adverse cardiac events (MACE)

    Percentage of participants that had either cardiac death, target vessel-related MI*, or ischemia-driven target-vessel revascularization

    Measured: 12 months and yearly thereafter until 5 years

  6. All-cause mortality

    mortality rate

    Measured: 12 months and yearly thereafter until 5 years

  7. Cardiac death

    Cardiac death rate

    Measured: 12 months and yearly thereafter until 5 years

  8. Q-wave MI

    percentage of participants that had Q-wave MI

    Measured: 12 months and yearly thereafter until 5 years

  9. Non Q-wave MI

    percentage of participants that had Non Q-wave MI

    Measured: 12 months and yearly thereafter until 5 years

  10. Any MI

    percentage of participants that had any MI

    Measured: 12 months and yearly thereafter until 5 years

  11. Target vessel MI

    percentage of participants that had MI related to target vessel

    Measured: 12 months and yearly thereafter until 5 years

  12. Any revascularization

    percentage of participants that had any revascularization

    Measured: 12 months and yearly thereafter until 5 years

  13. Ischemia-driven TLR

    percentage of participants that had Ischemia-driven TLR

    Measured: 12 months and yearly thereafter until 5 years

  14. Probable stent thrombosis

    percentage of participants that had Probable stent thrombosis

    Measured: 12 months and yearly thereafter until 5 years

  15. Definite stent thrombosis

    percentage of participants that had Definite stent thrombosis

    Measured: 12 months and yearly thereafter until 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2020
  2. Study start17 Feb 2021
  3. Primary completion10 Dec 2023
  4. Study completion30 Jun 2027 (estimated)

Resources

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
None (open label)
Enrolment
1,720 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04562532
Sponsor's protocol ID
TARGET-IV_NA
Acronym
TARGET-IV_NA
Status last verified
Jul 2023
First submitted
18 Sep 2020
Last updated
24 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Yeh RW, Bertrand OF, Mahmud E, Barbato E, Falah B, Issever MO, Redfors B, Popma A, Curtis M, van Royen N, Tanguay JF, Janssens L, Newman WN, Teeuwen K, Choi JW, Dirksen MT, Maehara A, Leon MB. Randomized Comparison of Novel Low-Dose Sirolimus-Eluting Biodegradable Polymer Stent vs Second-Generation DES: TARGET-IV NA Trial. J Am Coll Cardiol. 2025 Feb 18;85(6):563-574. doi: 10.1016/j.jacc.2024.10.074. Epub 2024 Oct 30.

    PubMed 39480379

Questions about this trial

What is this clinical trial studying?

A study testing Microport Firehawk stent and 2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent) in people with Coronary Artery Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 57 sites in 5 countries.

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 9 inclusion and 31 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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Canada, Denmark, Belgium, Netherlands. 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?

This study is still under way. Results are not available in the source record yet.

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?

Target Lesion Failure (time frame: 12 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 NCT04562532, 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 24 Jul 2024.

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