Firehawk Rapamycin Target Eluting Coronary Stent North American Trial
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Microport Firehawk stentDevice: 2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent)
- Registration Number
- NCT04562532
- Lead Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1720
- 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Firehawk group Microport Firehawk stent Participants implant Firehawk stent(s) 2nd generation DES 2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent) 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)
- Primary Outcome Measures
Name Time Method Target Lesion Failure 12 months 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
- Secondary Outcome Measures
Name Time Method Target Lesion Failure 12 months and yearly thereafter until 5 years 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)
Probable stent thrombosis 12 months and yearly thereafter until 5 years percentage of participants that had Probable stent thrombosis
Target vessel failure 12 months and yearly thereafter until 5 years Percentage of participants that had either cardiac death, target vessel-related MI\*, or ischemia-driven target-vessel revascularization
All-cause mortality 12 months and yearly thereafter until 5 years mortality rate
Target vessel MI 12 months and yearly thereafter until 5 years percentage of participants that had MI related to target vessel
Ischemia-driven TLR 12 months and yearly thereafter until 5 years percentage of participants that had Ischemia-driven TLR
In-stent late loss 13 months In-stent late loss at 13 months post-procedure as measured by quantitative coronary angiography (QCA)
Neointimal thickness 13 months Neointimal thickness at 3 months measured by Optical Coherence Tomography (OCT)
Major adverse cardiac events (MACE) 12 months and yearly thereafter until 5 years Percentage of participants that had either cardiac death, target vessel-related MI\*, or ischemia-driven target-vessel revascularization
Cardiac death 12 months and yearly thereafter until 5 years Cardiac death rate
Q-wave MI 12 months and yearly thereafter until 5 years percentage of participants that had Q-wave MI
Any revascularization 12 months and yearly thereafter until 5 years percentage of participants that had any revascularization
Definite stent thrombosis 12 months and yearly thereafter until 5 years percentage of participants that had Definite stent thrombosis
Any MI 12 months and yearly thereafter until 5 years percentage of participants that had any MI
Non Q-wave MI 12 months and yearly thereafter until 5 years percentage of participants that had Non Q-wave MI
Trial Locations
- Locations (57)
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
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
St. Vincent Heart Center of Indiana
🇺🇸Indianapolis, Indiana, United States
JFK Medical Center
🇺🇸Atlantis, Florida, United States
Copenhagen University Hospital - Rigshospitalet
🇩🇰Copenhagen, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Cardiology PC
🇺🇸Birmingham, Alabama, United States
Eastern Maine Medical Center-Northern Light Cardiology
🇺🇸Bangor, Maine, United States
Mercy Gilbert Medical Center
🇺🇸Gilbert, Arizona, United States
UC San Diego School of Medicine
🇺🇸La Jolla, California, United States
Memorial Hospital Jacksonville
🇺🇸Jacksonville, Florida, United States
Clearwater Cardiovascular Consultants
🇺🇸Clearwater, Florida, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Atlanta Veterans Affairs Medical Center
🇺🇸Decatur, Georgia, United States
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
McLaren Bay
🇺🇸Bay City, Michigan, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Metropolitan Heart Vascular Institute
🇺🇸Coon Rapids, Minnesota, United States
St Dominic Hospital
🇺🇸Jackson, Mississippi, United States
Bryan Medical Center East
🇺🇸Lincoln, Nebraska, United States
Boone Hospital Center
🇺🇸Columbia, Missouri, United States
St. Francis Hospital & Heart Center
🇺🇸Roslyn, New York, United States
Columbia University Medical Center/NYPH
🇺🇸New York, New York, United States
NC Heart and Vascular Research
🇺🇸Raleigh, North Carolina, United States
Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States
UPMC Hamot
🇺🇸Erie, Pennsylvania, United States
Baylor Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
Texas Tech University Health
🇺🇸Lubbock, Texas, United States
Onze Lieve Vrouw Hospital
🇧🇪Aalst, Belgium
York PCI Group Inc
🇨🇦Newmarket, Ontario, Canada
University of Calgary- Foothills Medical Center
🇨🇦Calgary, Alberta, Canada
IUPQ
🇨🇦Québec, Qebec, Canada
CIUSSE de l'estrie CHUS
🇨🇦Sherbrooke, Quebec, Canada
Aarhus University Hospital
🇩🇰Aarhus, Denmark
CHUM
🇨🇦Montréal, Quebec, Canada
Roskilde University Hospital
🇩🇰Roskilde, Denmark
Radbout UMC
🇳🇱Nijmegen, Netherlands
McLaren Greater Lansing
🇺🇸Lansing, Michigan, United States
CCC Research - Countryside
🇺🇸Clearwater, Florida, United States
Riverside Community Hospital
🇺🇸Riverside, California, United States
Mayo Clinic Health System
🇺🇸La Crosse, Wisconsin, United States
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Mercy Health St. Vincent Medical Center LLC
🇺🇸Toledo, Ohio, United States
East Texas Medical Center
🇺🇸Tyler, Texas, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
Montreal Heart Institute
🇨🇦Montréal, Quebec, Canada
McLaren Northern Michigan
🇺🇸Petoskey, Michigan, United States
AnMed Health
🇺🇸Anderson, South Carolina, United States
Turkey Creek Medical Center
🇺🇸Knoxville, Tennessee, United States
UPMC Harrisburg Hospital
🇺🇸Harrisburg, Pennsylvania, United States
St. Boniface Hospital Inc.
🇨🇦Winnipeg, Manitoba, Canada
Yale New Heaven Hospital
🇺🇸New Haven, Connecticut, United States
St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States