BridgeMD
A study designed to evaluate a modified Anti-Platelet Therapy (drugs that preventblood platelets from clotting) after implantation of a Firehawk drug-eluting stent (metallic tube, which is covered with a drug and inserted into stenosed blood vessels of the heart in order to keep them open) in patients who have experienced a heart attack and were treated with complete revascularisation (the lesion related to the heart attack and all other significant lesions were treated)
EU CTIS ID: 2024-519854-35-00
What this study is testing
The primary objective is to evaluate a modified Anti-Platelet Therapy, associated with low-dose rapamycin DES Firehawk in Acute Myocardial Infarction Patients treated with complete revascularization strategy, in reaching non-inferior NACCE (among clinically stable, low to moderate complexity acute MI patients).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Angiographic criteria: successful revascularization in native coronary arteries only, in vessels with visual reference diameter ≥2.25 mm and ≤ 4.00 mm, implanted with the study device, with a maximum of 3 lesions treated and 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.
You likely can't join if
- Subjects with prior STEMI or prior PCI within 12 months before index admission
- Participation in another interventional clinical trial
- Angiographic criteria: In-stent restenosis or thrombosis Chronic total occlusion, or Severe calcification, or True bifurcation disease and side branch diameter ≥ 2mm, or bifurcation treated with 2 stents, or Left main coronary artery lesion, or Residual untreated dissection ≥ C, or Implantation of a non-study stent
- Subject is deemed to receive preferentially CABG within 1 year
- Prior Coronary Artery Bypass Graft (CABG) Surgery, Prior stent thrombosis, Ischemic stroke or ICH within 12 months
- Cardiogenic shock, Secondary PCI, Fibrinolysis
See the full eligibility criteria
- 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
- Angiographic criteria: successful revascularization in native coronary arteries only, in vessels with visual reference diameter ≥2.25 mm and ≤ 4.00 mm, implanted with the study device, with a maximum of 3 lesions treated and 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.
- Subjects with prior STEMI or prior PCI within 12 months before index admission
- Participation in another interventional clinical trial
- Angiographic criteria: In-stent restenosis or thrombosis Chronic total occlusion, or Severe calcification, or True bifurcation disease and side branch diameter ≥ 2mm, or bifurcation treated with 2 stents, or Left main coronary artery lesion, or Residual untreated dissection ≥ C, or Implantation of a non-study stent
- Subject is deemed to receive preferentially CABG within 1 year
- Prior Coronary Artery Bypass Graft (CABG) Surgery, Prior stent thrombosis, Ischemic stroke or ICH within 12 months
- Cardiogenic shock, Secondary PCI, Fibrinolysis
- Planned PCI, CABG, or surgery within 12 months
- Need for Oral Anti-Coagulation therapy
- 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, 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 study protocol
- Known hypersensitivity or contraindication to any medication used in the study or any of the study stent's components/compounds
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.