TARGET-IV_NA: Firehawk Rapamycin Target Eluting Coronary Stent North American Trial

• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04562532
• Collaborator: (none)
• Enrollment: 1,720
• Locations: 57
• Arms: 2
• Anticipated Duration (Months): 76.4
• Patients Per Site: 30.2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: Microport Firehawk stent; Device: 2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent)	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1720 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicenter Randomized Assessment of the Firehawk™ Rapamycin TARGET Eluting Cobalt Chromium Coronary Stent System - North American Trial
• Actual Study Start Date: Feb 17, 2021
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Jun 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Firehawk group Participants implant Firehawk stent(s)	Device: Microport Firehawk stent; MicroPort Firehawk biodegradable polymer rapamycin target eluting stent; Other Names: MicroPort Firehawk rapamycin target eluting stent
Active Comparator: 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)	Device: 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)

Outcome Measures

Primary Outcome Measures

1. 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

1. In-stent late loss [13 months]

   In-stent late loss at 13 months post-procedure as measured by quantitative coronary angiography (QCA)

2. Neointimal thickness [13 months]

   Neointimal thickness at 3 months measured by Optical Coherence Tomography (OCT)

3. 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)

4. 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

5. 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

6. All-cause mortality [12 months and yearly thereafter until 5 years]

   mortality rate

7. Cardiac death [12 months and yearly thereafter until 5 years]

   Cardiac death rate

8. Q-wave MI [12 months and yearly thereafter until 5 years]

   percentage of participants that had Q-wave MI

9. Non Q-wave MI [12 months and yearly thereafter until 5 years]

   percentage of participants that had Non Q-wave MI

10. Any MI [12 months and yearly thereafter until 5 years]

    percentage of participants that had any MI

11. Target vessel MI [12 months and yearly thereafter until 5 years]

    percentage of participants that had MI related to target vessel

12. Any revascularization [12 months and yearly thereafter until 5 years]

    percentage of participants that had any revascularization

13. Ischemia-driven TLR [12 months and yearly thereafter until 5 years]

    percentage of participants that had Ischemia-driven TLR

14. Probable stent thrombosis [12 months and yearly thereafter until 5 years]

    percentage of participants that had Probable stent thrombosis

15. Definite stent thrombosis [12 months and yearly thereafter until 5 years]

    percentage of participants that had Definite stent thrombosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology PC	Birmingham	Alabama	United States	35211
2	Mercy Gilbert Medical Center	Gilbert	Arizona	United States	85297
3	UC San Diego School of Medicine	La Jolla	California	United States	90903
4	Riverside Community Hospital	Riverside	California	United States	92501
5	Sharp Memorial Hospital	San Diego	California	United States	92123
6	Santa Barbara Cottage Hospital	Santa Barbara	California	United States	93105
7	Yale New Heaven Hospital	New Haven	Connecticut	United States	06511
8	JFK Medical Center	Atlantis	Florida	United States	33462
9	CCC Research - Countryside	Clearwater	Florida	United States	33756
10	Clearwater Cardiovascular Consultants	Clearwater	Florida	United States	33756
11	Memorial Hospital Jacksonville	Jacksonville	Florida	United States	32216
12	Atlanta Veterans Affairs Medical Center	Decatur	Georgia	United States	30033
13	Elkhart General Hospital	Elkhart	Indiana	United States	46514
14	St. Vincent Heart Center of Indiana	Indianapolis	Indiana	United States	46260
15	The University of Kansas Medical Center	Kansas City	Kansas	United States	66160
16	Eastern Maine Medical Center-Northern Light Cardiology	Bangor	Maine	United States	04401
17	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
18	Brigham and Womens Hospital	Boston	Massachusetts	United States	02115
19	Beth Israel Deaconess Medical Center, Inc.	Boston	Massachusetts	United States	02215
20	St. Joseph Mercy Hospital	Ann Arbor	Michigan	United States	13203
21	McLaren Bay	Bay City	Michigan	United States	48708
22	McLaren Greater Lansing	Lansing	Michigan	United States	48910
23	McLaren Northern Michigan	Petoskey	Michigan	United States	49770
24	Metropolitan Heart Vascular Institute	Coon Rapids	Minnesota	United States	55433
25	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	United States	55407
26	St Dominic Hospital	Jackson	Mississippi	United States	39216
27	Boone Hospital Center	Columbia	Missouri	United States	65201
28	Bryan Medical Center East	Lincoln	Nebraska	United States	68506
29	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
30	Columbia University Medical Center/NYPH	New York	New York	United States	10032
31	St. Francis Hospital & Heart Center	Roslyn	New York	United States	11576
32	NC Heart and Vascular Research	Raleigh	North Carolina	United States	27607
33	Mercy Health St. Vincent Medical Center LLC	Toledo	Ohio	United States	43608
34	Doylestown Hospital	Doylestown	Pennsylvania	United States	18901
35	UPMC Hamot	Erie	Pennsylvania	United States	16550
36	UPMC Harrisburg Hospital	Harrisburg	Pennsylvania	United States	17104
37	Rhode Island Hospital	Providence	Rhode Island	United States	02903
38	AnMed Health	Anderson	South Carolina	United States	29621
39	Turkey Creek Medical Center	Knoxville	Tennessee	United States	37934
40	Baylor Heart and Vascular Hospital	Dallas	Texas	United States	75226
41	Texas Tech University Health	Lubbock	Texas	United States	79430
42	East Texas Medical Center	Tyler	Texas	United States	75701
43	Charleston Area Medical Center	Charleston	West Virginia	United States	25304
44	Mayo Clinic Health System	La Crosse	Wisconsin	United States	54601
45	Onze Lieve Vrouw Hospital	Aalst		Belgium
46	University of Calgary- Foothills Medical Center	Calgary	Alberta	Canada	T2W1S7
47	St. Boniface Hospital Inc.	Winnipeg	Manitoba	Canada	R2H2A6
48	York PCI Group Inc	Newmarket	Ontario	Canada	L3Y2P7
49	IUPQ	Québec	Qebec	Canada	G1V4G5
50	Montreal Heart Institute	Montréal	Quebec	Canada	H1T1C8
51	CHUM	Montréal	Quebec	Canada	H2X0A9
52	CIUSSE de l'estrie CHUS	Sherbrooke	Quebec	Canada	J1J3H5
53	Aarhus University Hospital	Aarhus		Denmark
54	Copenhagen University Hospital - Rigshospitalet	Copenhagen		Denmark
55	Odense University Hospital	Odense		Denmark
56	Roskilde University Hospital	Roskilde		Denmark
57	Radbout UMC	Nijmegen		Netherlands

Sponsors and Collaborators

• Shanghai MicroPort Medical (Group) Co., Ltd.

Investigators

• Study Chair: Martin Leon, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai MicroPort Medical (Group) Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04562532
• Other Study ID Numbers: TARGET-IV_NA
• First Posted: Sep 24, 2020
• Last Update Posted: Jul 27, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Coronary Artery Disease; Sirolimus

Study Results

No Results Posted as of Jul 27, 2022