Firehawk Rapamycin Target Eluting Coronary Stent North American Trial

NCT04562532 | Active Not Recruiting FDA Device

• 1 other identifier: TARGET-IV_NA
• Study Type: interventional
• Target: 1,720
• Locations: 5 countries
• Sites: 57

Brief 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 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (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

  12 months

Secondary Outcomes (15)

• In-stent late loss

  13 months

• Neointimal thickness

  13 months

• Target Lesion Failure

  12 months and yearly thereafter until 5 years

• Target vessel failure

  12 months and yearly thereafter until 5 years

• Major adverse cardiac events (MACE)

  12 months and yearly thereafter until 5 years

Study Arms (2)

Firehawk group

EXPERIMENTAL

Participants implant Firehawk stent(s)

Device: Microport Firehawk stent

2nd generation DES

ACTIVE COMPARATOR

Participants 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)

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

Interventions

Microport Firehawk stent DEVICE

MicroPort Firehawk biodegradable polymer rapamycin target eluting stent

Also known as: MicroPort Firehawk rapamycin target eluting stent

Firehawk group

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)

2nd generation DES

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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

You may not qualify if:

• 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%.
• 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.

Sponsors & Collaborators

• Shanghai MicroPort Medical (Group) Co., Ltd.: lead

Study Sites (57)

Cardiology PC

Birmingham, Alabama, 35211, United States

Location

Mercy Gilbert Medical Center

Gilbert, Arizona, 85297, United States

Location

UC San Diego School of Medicine

La Jolla, California, 90903, United States

Location

Riverside Community Hospital

Riverside, California, 92501, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

Yale New Heaven Hospital

New Haven, Connecticut, 06511, United States

Location

JFK Medical Center

Atlantis, Florida, 33462, United States

Location

CCC Research - Countryside

Clearwater, Florida, 33756, United States

Location

Clearwater Cardiovascular Consultants

Clearwater, Florida, 33756, United States

Location

Memorial Hospital Jacksonville

Jacksonville, Florida, 32216, United States

Location

Atlanta Veterans Affairs Medical Center

Decatur, Georgia, 30033, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46514, United States

Location

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46260, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Eastern Maine Medical Center-Northern Light Cardiology

Bangor, Maine, 04401, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center, Inc.

Boston, Massachusetts, 02215, United States

Location

St. Joseph Mercy Hospital

Ann Arbor, Michigan, 13203, United States

Location

McLaren Bay

Bay City, Michigan, 48708, United States

Location

McLaren Greater Lansing

Lansing, Michigan, 48910, United States

Location

McLaren Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Metropolitan Heart Vascular Institute

Coon Rapids, Minnesota, 55433, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

St Dominic Hospital

Jackson, Mississippi, 39216, United States

Location

Boone Hospital Center

Columbia, Missouri, 65201, United States

Location

Bryan Medical Center East

Lincoln, Nebraska, 68506, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

St. Francis Hospital & Heart Center

Roslyn, New York, 11576, United States

Location

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

Mercy Health St. Vincent Medical Center LLC

Toledo, Ohio, 43608, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

UPMC Hamot

Erie, Pennsylvania, 16550, United States

Location

UPMC Harrisburg Hospital

Harrisburg, Pennsylvania, 17104, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

AnMed Health

Anderson, South Carolina, 29621, United States

Location

Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

Texas Tech University Health

Lubbock, Texas, 79430, United States

Location

East Texas Medical Center

Tyler, Texas, 75701, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

Mayo Clinic Health System

La Crosse, Wisconsin, 54601, United States

Location

Onze Lieve Vrouw Hospital

Aalst, Belgium

Location

University of Calgary- Foothills Medical Center

Calgary, Alberta, T2W1S7, Canada

Location

St. Boniface Hospital Inc.

Winnipeg, Manitoba, R2H2A6, Canada

Location

York PCI Group Inc

Newmarket, Ontario, L3Y2P7, Canada

Location

IUPQ

Québec, Qebec, G1V4G5, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

Location

CHUM

Montreal, Quebec, H2X0A9, Canada

Location

CIUSSE de l'estrie CHUS

Sherbrooke, Quebec, J1J3H5, Canada

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Copenhagen University Hospital - Rigshospitalet

Copenhagen, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Roskilde University Hospital

Roskilde, Denmark

Location

Radbout UMC

Nijmegen, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 39480379 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Martin Leon

  Columbia University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: February 17, 2021
• Primary Completion: December 10, 2023
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 24, 2024

Record last verified: 2023-07

Locations

BE (1); NL (1); US (44); DK (4); CA (7)