Status:
COMPLETED
Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy
Lead Sponsor:
MicroPort CRM
Collaborating Sponsors:
European Cardiovascular Research Center
Conditions:
Myocardial Infarction, Acute
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study aims to evaluate a modified antiplatelet therapy associated with Firehawk low-dose rapamycin DES in acute myocardial infarction patients treated with complete revascularization strategy. The...
Eligibility Criteria
Inclusion
- Inclusion Criteria (General):
- Troponin-positive Non-ST-Elevation MI, requiring early invasive treatment (PCI), or ST-Elevation MI requiring primary PCI, and PCI occurred within the last 7 days
- Subject is eligible for per-protocol antiplatelet treatments
- Written informed consent
- Inclusion Criteria (Procedural/angiographic):
- Successful revascularization
- All treated lesions:
- In native coronary arteries only
- In vessels with visual reference diameter ≥2.25 mm and ≤ 4.00 mm
- Implanted with the study 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.
- Exclusion Criteria (General):
- 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
- Need for Oral Anti-Coagulation therapy
- Ischemic stroke or ICH within 12 months
- 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
- 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
- Expected non-adherence to protocol or 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
- Participation in another interventional clinical trial
- Woman who is pregnant, nursing or with known intention to procreate
- Exclusion Criteria (Procedural/Angiographic):
- In-stent restenosis or thrombosis
- Chronic total occlusion
- Severe calcification
- True bifurcation disease and side branch diameter ≥ 2mm, or bifurcation treated with 2 stents
- Left main coronary artery lesion
- Residual untreated dissection ≥ C
- Implantation of a non-study stent
- Subject is deemed to receive preferentially CABG within 1 year
Exclusion
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2025
Estimated Enrollment :
2248 Patients enrolled
Trial Details
Trial ID
NCT04753749
Start Date
March 25 2021
End Date
May 5 2025
Last Update
July 29 2025
Active Locations (40)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsklinikum
Sankt Pölten, Austria
2
CHU Annecy
Annecy, France
3
Clinique Roseraie
Aubervilliers, France
4
CH Bastia
Bastia, France