Firehawk Rapamycin Target Eluting Coronary Stent North American Trial

Running, not enrolling · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT04562532

Run by

Shanghai MicroPort Medical (Group) Co., Ltd.

People needed

1720

Starts

2021-02-17

Expected to finish

2027-06-30

Last updated by the study team

2024-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.
• 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.
• 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

Where it is running

• Mercy Gilbert Medical Center — Gilbert, Arizona, United States
• UC San Diego School of Medicine — La Jolla, California, United States
• Riverside Community Hospital — Riverside, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• Yale New Heaven Hospital — New Haven, Connecticut, United States
• JFK Medical Center — Atlantis, Florida, United States
• CCC Research - Countryside — Clearwater, Florida, United States
• Clearwater Cardiovascular Consultants — Clearwater, Florida, United States
• Memorial Hospital Jacksonville — Jacksonville, Florida, United States
• Atlanta Veterans Affairs Medical Center — Decatur, Georgia, United States
• Elkhart General Hospital — Elkhart, Indiana, United States
• St. Vincent Heart Center of Indiana — Indianapolis, Indiana, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Eastern Maine Medical Center-Northern Light Cardiology — Bangor, Maine, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Womens Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center, Inc. — Boston, Massachusetts, United States
• St. Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• McLaren Bay — Bay City, Michigan, United States
• McLaren Greater Lansing — Lansing, Michigan, United States
• McLaren Northern Michigan — Petoskey, Michigan, United States
• Metropolitan Heart Vascular Institute — Coon Rapids, Minnesota, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Cardiology PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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