The TARGET-IV NA Trial: Multicenter Randomized Assessment of the Firehawk® rapamycin TARGET eluting cobalt chromium coronary stent system –North American Trial

  • STATUS
    Recruiting
  • sponsor
    Shanghai MicroPort Medical (Group) Co., Ltd.
Updated on 18 October 2021
heart disease
unstable angina
ischemia
coronary disease

Summary

The aim of this 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), 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

  • Condition: Coronary Artery Disease
  • Device: Firehawk® stent system
  • Clinical Trial Identifier: NCT04562532

Details
Condition Heart Disease, Coronary Disease, Heart disease, Stent, Cardiac Disease, Coronary Artery Disease, Myocardial Ischemia, Heart Diseases, Myocardial Ischemia
Clinical Study IdentifierTX276528
SponsorShanghai MicroPort Medical (Group) Co., Ltd.
Last Modified on18 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years
Patients with an indication for PCI including angina (stable or unstable), silent ischemia, NSTEMI, or recent STEMI (STEMI >24 hours and in whom enzyme levels have peaked)
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. Complex lesions are allowed including calcified lesions, ostial lesions, tortuous lesions, and protected left main lesions
3. Overlapping stents are allowed

Exclusion Criteria

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 or requiring pressors or hemodynamic support, including IABP
Known LVEF <30%
Calculated creatinine clearance <30 mL/min using Cockcroft-Gault equation
Hemoglobin <10 g/dL., platelet count <100,000 cells/mm3 or >700,000 cells/mm3 and white blood cell count <3,000 cells/mm3
Other serious medical illness with a life-expectancy < 24 months (e.g., cancer, severe heart failure, severe lung disease)
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)
Angiographic Exclusion Criteria
1. Unprotected left main interventions
2. Bifurcation lesions with intended dual stent implantations
3. DES restenotic lesions and Lesion with intended ≥ 3 stent implantation
4. Any lesion in the target vessel that is likely to require PCI within 12 months
5. Stent lengths >36mm for diameters 2.0 mm and 2.25 mm (i.e., very long thin stents)
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