TARGET FIRST Evaluation of a modified Anti-Platelet Therapy associated with low-dose rapamycin DES Firehawk in Acute Myocardial Infarction Patients treated with complete revascularization strategy

Recruiting

• Conditions: Myocardial infarction; 10011082

• Registration Number: NL-OMON54279
• Lead Sponsor: Sorin Biomedica CRM SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

Subjects must meet all of the following criteria to be eligible for enrolment: Clinical • Subject is >= 18 years old • Subject has been hospitalised for troponin-positive Non-ST-Elevation MI, requiring early invasive treatment (PCI), or ST-Elevation MI requiring primary PCI, and this PCI occurred within the last 7 days • Subject is eligible for per-protocol antiplatelet treatments • Subject understands and agrees with the trial requirements and procedures, and provides written informed consent before any trial-specific tests or procedures are performed • Subject is willing to comply with all protocol requirements including antiplatelet treatment strategies and follow-up visits Procedural/angiographic (related to the treatment of the (N)STEMI • Successful revascularization: - Successful delivery and deployment of the Firehawk stent(s), with final residual stenosis of <30% (visually) for all target lesions - No occurrence of significant event (such as MI, unplanned revascularisation, stent thrombosis, stroke, major vascular complication/bleeding). • All the treated lesions: - In native coronary arteries only, - In vessels with visual reference diameter >=2.25 mm and <= 4.00 mm - Implanted with the medical device - Maximum 3 lesions treated (*) - Maximum total stent length <= 80 mm. • Complete revascularization (**) performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 7 days from the index procedure. Physiologic assessment highly recommended for lesions with stenosis between 50% and 69%.

Exclusion Criteria

Patients fulfilling any of the following criteria are not eligible: • Subjects with prior STEMI or prior PCI within 12 months before index admission • Prior Coronary Artery Bypass Graft (CABG) Surgery • Cardiogenic shock • Secondary PCI • Fibrinolysis • Prior stent thrombosis • Planned PCI, CABG, or surgery within 12 months after the enrolment • Need for Oral Anti-Coagulation medications (or NOAC) • Ischemic stroke or intracerebral hemorrhage (spontaneous or traumatic) within 12 months prior to index procedure • eGFR <30 mL/min/1.73 m2 or dialysis • Active bleeding at time of inclusion or high risk for major bleeding • History of bleeding diathesis or coagulopathy or subject refuse blood transfusions • Stage B or C liver cirrhosis or active cancer within 12 months prior to index procedure (or currently receiving chemotherapy or planned to receive chemotherapy) • Baseline haemoglobin <13 g/dL (12g/dL for women) or anaemia requiring transfusion in the 4 weeks prior to index procedure • Moderate or severe thrombocytopenia (<100,000/L) • Expected non-adherence to study protocol (such as current problems with substance abuse, severe impairment of cognitive skills, *) • Estimated life expectancy <=12 months • Known hypersensitivity or contraindication to any medication used in the study or any of the study stent*s components/compounds (e.g., cobalt chromium alloy, sirolimus, or structurally related compounds, polymer or individual components, P2Y12 inhibitors, or aspirin). • Subject participates in another interventional (device or drug) clinical trial within 12 months after the index procedure • Subject is a woman who is pregnant, nursing or with known intention to procreate within 12 months after the index procedure (woman of child-bearing potential who is sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)). Investigator may require a pregnancy test to be performed within 7 days prior to the enrolment in women of child-bearing potential) Angiographic: • Any of : - In-stent restenosis or thrombosis - Chronic total occlusion - Severe calcification - True bifurcation disease (Medina class x,x,1) and side branch diameter >= 2mm (visual reference visual diameter) or bifurcation treated with 2 stents - Left main coronary artery lesion - Residual untreated dissection >= C - Implantation of a non-study stent • Extent and severity of disease is such that patient is deemed to receive preferentially CABG within 1 year (based on current ESC guidelines)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Net Adverse Clinical and Cerebral Events (NACCE) defined as a composite of all<br /><br>cause death, non-fatal myocardial infarction, definite/probable stent<br /><br>thrombosis, stroke, or Bleeding Academic Research Consortium (BARC) type 3 or 5<br /><br>bleeding at 11 months post randomization (12 months post index procedure).</p><br>