Firehawk Rapamycin Target Eluting Coronary Stent North American Trial

Coronary Artery Disease Clinical Trial

— TARGET-IV_NA  

Official title:

Multicenter Randomized Assessment of the Firehawk™ Rapamycin TARGET Eluting Cobalt Chromium Coronary Stent System - North American Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04562532
• Other study ID #: TARGET-IV_NA
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: June 30, 2027

Study information

• Verified date: July 2023
• Source: Shanghai MicroPort Medical (Group) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1720
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• 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)

Locations

Country	Name	City	State
Belgium	Onze Lieve Vrouw Hospital	Aalst
Canada	University of Calgary- Foothills Medical Center	Calgary	Alberta
Canada	CHUM	Montréal	Quebec
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	York PCI Group Inc	Newmarket	Ontario
Canada	IUPQ	Québec	Qebec
Canada	CIUSSE de l'estrie CHUS	Sherbrooke	Quebec
Canada	St. Boniface Hospital Inc.	Winnipeg	Manitoba
Denmark	Aarhus University Hospital	Aarhus
Denmark	Copenhagen University Hospital - Rigshospitalet	Copenhagen
Denmark	Odense University Hospital	Odense
Denmark	Roskilde University Hospital	Roskilde
Netherlands	Radbout UMC	Nijmegen
United States	AnMed Health	Anderson	South Carolina
United States	St. Joseph Mercy Hospital	Ann Arbor	Michigan
United States	JFK Medical Center	Atlantis	Florida
United States	Eastern Maine Medical Center-Northern Light Cardiology	Bangor	Maine
United States	McLaren Bay	Bay City	Michigan
United States	Cardiology PC	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center, Inc.	Boston	Massachusetts
United States	Brigham and Womens Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	CCC Research - Countryside	Clearwater	Florida
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	Boone Hospital Center	Columbia	Missouri
United States	Metropolitan Heart Vascular Institute	Coon Rapids	Minnesota
United States	Baylor Heart and Vascular Hospital	Dallas	Texas
United States	Atlanta Veterans Affairs Medical Center	Decatur	Georgia
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Elkhart General Hospital	Elkhart	Indiana
United States	UPMC Hamot	Erie	Pennsylvania
United States	Mercy Gilbert Medical Center	Gilbert	Arizona
United States	UPMC Harrisburg Hospital	Harrisburg	Pennsylvania
United States	St. Vincent Heart Center of Indiana	Indianapolis	Indiana
United States	St Dominic Hospital	Jackson	Mississippi
United States	Memorial Hospital Jacksonville	Jacksonville	Florida
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	Turkey Creek Medical Center	Knoxville	Tennessee
United States	Mayo Clinic Health System	La Crosse	Wisconsin
United States	UC San Diego School of Medicine	La Jolla	California
United States	McLaren Greater Lansing	Lansing	Michigan
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Bryan Medical Center East	Lincoln	Nebraska
United States	Texas Tech University Health	Lubbock	Texas
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Yale New Heaven Hospital	New Haven	Connecticut
United States	Columbia University Medical Center/NYPH	New York	New York
United States	McLaren Northern Michigan	Petoskey	Michigan
United States	Rhode Island Hospital	Providence	Rhode Island
United States	NC Heart and Vascular Research	Raleigh	North Carolina
United States	Riverside Community Hospital	Riverside	California
United States	St. Francis Hospital & Heart Center	Roslyn	New York
United States	Sharp Memorial Hospital	San Diego	California
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Mercy Health St. Vincent Medical Center LLC	Toledo	Ohio
United States	East Texas Medical Center	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai MicroPort Medical (Group) Co., Ltd.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Denmark,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	In-stent late loss	In-stent late loss at 13 months post-procedure as measured by quantitative coronary angiography (QCA)	13 months
Secondary	Neointimal thickness	Neointimal thickness at 3 months measured by Optical Coherence Tomography (OCT)	13 months
Secondary	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)	12 months and yearly thereafter until 5 years
Secondary	Target vessel failure	Percentage of participants that had either cardiac death, target vessel-related MI*, or ischemia-driven target-vessel revascularization	12 months and yearly thereafter until 5 years
Secondary	Major adverse cardiac events (MACE)	Percentage of participants that had either cardiac death, target vessel-related MI*, or ischemia-driven target-vessel revascularization	12 months and yearly thereafter until 5 years
Secondary	All-cause mortality	mortality rate	12 months and yearly thereafter until 5 years
Secondary	Cardiac death	Cardiac death rate	12 months and yearly thereafter until 5 years
Secondary	Q-wave MI	percentage of participants that had Q-wave MI	12 months and yearly thereafter until 5 years
Secondary	Non Q-wave MI	percentage of participants that had Non Q-wave MI	12 months and yearly thereafter until 5 years
Secondary	Any MI	percentage of participants that had any MI	12 months and yearly thereafter until 5 years
Secondary	Target vessel MI	percentage of participants that had MI related to target vessel	12 months and yearly thereafter until 5 years
Secondary	Any revascularization	percentage of participants that had any revascularization	12 months and yearly thereafter until 5 years
Secondary	Ischemia-driven TLR	percentage of participants that had Ischemia-driven TLR	12 months and yearly thereafter until 5 years
Secondary	Probable stent thrombosis	percentage of participants that had Probable stent thrombosis	12 months and yearly thereafter until 5 years
Secondary	Definite stent thrombosis	percentage of participants that had Definite stent thrombosis	12 months and yearly thereafter until 5 years