Clinical trial NCT04562532: Firehawk Rapamycin Target Eluting Coronary Stent North American Trial
Official title: Multicenter Randomized Assessment of the Firehawk™ Rapamycin TARGET Eluting Cobalt Chromium Coronary Stent System - North American Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-24
Enrollment: 1720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years.
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.

Angiographic inclusion criteria:

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:

1. 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.
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.

Angiographic Exclusion Criteria:

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

Primary outcomes:
measure: Target Lesion Failure
timeFrame: 12 months
Secondary outcomes:
measure: In-stent late loss
timeFrame: 13 months
measure: Neointimal thickness
timeFrame: 13 months
measure: Target Lesion Failure
timeFrame: 12 months and yearly thereafter until 5 years
measure: Target vessel failure
timeFrame: 12 months and yearly thereafter until 5 years
measure: Major adverse cardiac events (MACE)
timeFrame: 12 months and yearly thereafter until 5 years
measure: All-cause mortality
timeFrame: 12 months and yearly thereafter until 5 years
measure: Cardiac death
timeFrame: 12 months and yearly thereafter until 5 years
measure: Q-wave MI
timeFrame: 12 months and yearly thereafter until 5 years
measure: Non Q-wave MI
timeFrame: 12 months and yearly thereafter until 5 years
measure: Any MI
timeFrame: 12 months and yearly thereafter until 5 years
measure: Target vessel MI
timeFrame: 12 months and yearly thereafter until 5 years
measure: Any revascularization
timeFrame: 12 months and yearly thereafter until 5 years
measure: Ischemia-driven TLR
timeFrame: 12 months and yearly thereafter until 5 years
measure: Probable stent thrombosis
timeFrame: 12 months and yearly thereafter until 5 years
measure: Definite stent thrombosis
timeFrame: 12 months and yearly thereafter until 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology PC
state: Alabama
city: Gilbert
country: United States
facility: Mercy Gilbert Medical Center
state: Arizona
city: La Jolla
country: United States
facility: UC San Diego School of Medicine
state: California
city: Riverside
country: United States
facility: Riverside Community Hospital
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: New Haven
country: United States
facility: Yale New Heaven Hospital
state: Connecticut
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Clearwater
country: United States
facility: CCC Research - Countryside
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Jacksonville
country: United States
facility: Memorial Hospital Jacksonville
state: Florida
city: Decatur
country: United States
facility: Atlanta Veterans Affairs Medical Center
state: Georgia
city: Elkhart
country: United States
facility: Elkhart General Hospital
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Bangor
country: United States
facility: Eastern Maine Medical Center-Northern Light Cardiology
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center, Inc.
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Bay City
country: United States
facility: McLaren Bay
state: Michigan
city: Lansing
country: United States
facility: McLaren Greater Lansing
state: Michigan
city: Petoskey
country: United States
facility: McLaren Northern Michigan
state: Michigan
city: Coon Rapids
country: United States
facility: Metropolitan Heart Vascular Institute
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Jackson
country: United States
facility: St Dominic Hospital
state: Mississippi
city: Columbia
country: United States
facility: Boone Hospital Center
state: Missouri
city: Lincoln
country: United States
facility: Bryan Medical Center East
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital & Heart Center
state: New York
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Toledo
country: United States
facility: Mercy Health St. Vincent Medical Center LLC
state: Ohio
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Erie
country: United States
facility: UPMC Hamot
state: Pennsylvania
city: Harrisburg
country: United States
facility: UPMC Harrisburg Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Knoxville
country: United States
facility: Turkey Creek Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health
state: Texas
city: Tyler
country: United States
facility: East Texas Medical Center
state: Texas
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: La Crosse
country: United States
facility: Mayo Clinic Health System
state: Wisconsin
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Hospital
city: Calgary
country: Canada
facility: University of Calgary- Foothills Medical Center
state: Alberta
city: Winnipeg
country: Canada
facility: St. Boniface Hospital Inc.
state: Manitoba
city: Newmarket
country: Canada
facility: York PCI Group Inc
state: Ontario
city: Québec
country: Canada
facility: IUPQ
state: Qebec
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: CHUM
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSE de l'estrie CHUS
state: Quebec
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital - Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Roskilde University Hospital
city: Nijmegen
country: Netherlands
facility: Radbout UMC
Study officials:
affiliation: Columbia University
name: Martin Leon
role: STUDY_CHAIR
References: