Firehawk Rapamycin Target Eluting Coronary Stent North American Trial
NCT ID: NCT04562532
Last Updated: 2024-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
1720 participants
INTERVENTIONAL
2021-02-17
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Non-inferiority Study Comparing Firehawk Stent With Abbott Xience Family Stent (TARGET-AC)
NCT02520180
Randomized MicroPort's Firehawk DES Versus Xience V: TARGET I Trial
NCT01196819
Firehawk™ Coronary Stent System in the Treatment of Coronary Chronic Total Occlusion Lesion(s)
NCT03040934
Comparison One vs Six Months of Dual Antiplatelet Therapy After Implanted Firehawk TM Stent in High Bleeding Risk Patients With Coronary Artery Disease
NCT03287167
TARGET-PREMIER Trail in Evaluating the Safety and Efficacy of the Rapamycin Target Eluting Stent in CAS Treatment
NCT04951050
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Firehawk group
Participants implant Firehawk stent(s)
Microport Firehawk stent
MicroPort Firehawk biodegradable polymer rapamycin target eluting stent
2nd generation DES
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)
2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent)
* 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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Microport Firehawk stent
MicroPort Firehawk biodegradable polymer rapamycin target eluting stent
2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent)
* 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)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patient understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment.
3. 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.
4. Patient is willing to comply with all protocol-required follow-up evaluations.
1. 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.
2. The coronary anatomy is deemed likely to allow delivery of a study device to the target lesion(s).
3. 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.
4. Overlapping stents are allowed
Exclusion Criteria
2. PCI within the 24 hours preceding the baseline procedure.
3. History of stent thrombosis.
4. 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.
5. Subject is intubated.
6. Known LVEF \<30%.
7. 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).
8. Planned surgery within 6 months.
9. Subject has an indication for chronic oral anticoagulant treatment (with either vitamin K antagonists or novel anticoagulants - NOACs)
10. Calculated creatinine clearance \<30 mL/min using Cockcroft-Gault equation (\<40 mL/min for subjects participating in the angiographic follow-up sub-study).
11. Hemoglobin \<10 g/dL.
12. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3.
13. White blood cell (WBC) count \<3,000 cells/mm3.
14. Clinically significant liver disease.
15. Active peptic ulcer or active bleeding from any site.
16. Other serious medical illness with a life-expectancy \< 24 months (e.g. cancer, severe heart failure, severe lung disease).
17. A planned procedure that may cause non-compliance with the protocol or confound data interpretation.
18. 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.
19. 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).
20. Pregnancy or nursing (women of child-bearing potential must have a pregnancy test within 7 days prior to the index procedure).
21. Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.).
22. Subject has received an organ transplant or is on a waiting list for an organ transplant.
23. Subject is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease (e.g., HIV). Corticosteroids are allowed.
1. Unprotected left main interventions
2. Bifurcation lesions with intended dual stent implantations
3. DES restenotic lesions
4. Prior PCI in the target vessel in the 12 months prior to enrollment
5. Any lesion in the target vessel that is likely to require PCI within 12 months
6. Stent lengths \>36mm for diameters 2.0 mm and 2.25 mm (i.e., very long thin stents).
7. Lesion with intended ≥ 3 stent implantation
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai MicroPort Medical (Group) Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Martin Leon
Role: STUDY_CHAIR
Columbia University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cardiology PC
Birmingham, Alabama, United States
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
St Dominic Hospital
Jackson, Mississippi, United States
Boone Hospital Center
Columbia, Missouri, United States
Bryan Medical Center East
Lincoln, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Columbia University Medical Center/NYPH
New York, New York, United States
St. Francis Hospital & Heart Center
Roslyn, New York, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
Mercy Health St. Vincent Medical Center LLC
Toledo, Ohio, United States
Doylestown Hospital
Doylestown, Pennsylvania, United States
UPMC Hamot
Erie, Pennsylvania, United States
UPMC Harrisburg Hospital
Harrisburg, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
AnMed Health
Anderson, South Carolina, United States
Turkey Creek Medical Center
Knoxville, Tennessee, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, United States
Texas Tech University Health
Lubbock, Texas, United States
East Texas Medical Center
Tyler, Texas, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Mayo Clinic Health System
La Crosse, Wisconsin, United States
Onze Lieve Vrouw Hospital
Aalst, , Belgium
University of Calgary- Foothills Medical Center
Calgary, Alberta, Canada
St. Boniface Hospital Inc.
Winnipeg, Manitoba, Canada
York PCI Group Inc
Newmarket, Ontario, Canada
IUPQ
Québec, Qebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
CHUM
Montreal, Quebec, Canada
CIUSSE de l'estrie CHUS
Sherbrooke, Quebec, Canada
Aarhus University Hospital
Aarhus, , Denmark
Copenhagen University Hospital - Rigshospitalet
Copenhagen, , Denmark
Odense University Hospital
Odense, , Denmark
Roskilde University Hospital
Roskilde, , Denmark
Radbout UMC
Nijmegen, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TARGET-IV_NA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.