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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety and effectiveness of a shorter dual antiplatelet therapy (DAPT) using Prasugrel followed by Prasugrel alone compared to the standard one-year DAPT regimen in patients who have experienced ST Elevated Myocardial Infarction (STEMI). The study also compares two methods for guiding complete revascularization of non-culprit lesions in patients with multivessel disease: one using Optical Coherence Tomography (OCT) and the other using standard angiography. The study involves treating STEMI patients with a loading dose of Aspirin and Prasugrel, followed by treatment of the culprit lesion during the initial procedure. In patients with multivessel disease, non-culprit lesions will be treated in staged procedures within 15 days. These patients will be randomly assigned to either OCT-guided or angiography-guided revascularization. After 30 to 45 days, if they meet certain criteria, patients will be randomized to receive either Prasugrel monotherapy or continue the standard DAPT regimen. Participants will be followed for 35 months after randomization to monitor clinical outcomes at 11 and 35 months. Researchers will assess the success of the revascularization procedures, adherence to treatment, and any significant cardiovascular events. The study measures include the safety and efficacy of the shorter DAPT regimen and the effectiveness of OCT-guided versus angiography-guided revascularization immediately after the procedure.
Actively Recruiting
Researchers are evaluating the effectiveness, safety, and economic benefits of coronary lithotripsy compared to other procedures like cutting or super high pressure balloon angioplasty and ablative methods in treating severely calcified coronary artery lesions. The study focuses on patients with coronary artery disease who have severe calcification in their coronary arteries, aiming to improve the preparation and treatment of these blockages. This is a randomized, multicenter clinical trial assessing these different methods to better understand their benefits in lesion treatment. Participants receive either intravascular lithotripsy (IVL) using balloons with a burst pressure of up to 18 atmospheres or standard non-IVL methods such as special high pressure, super high pressure, cutting balloons, and ablative procedures for treating severely calcified lesions. The trial compares these treatment groups to assess additional benefits of coronary lithotripsy. Treatments are performed during the interventional procedure aimed at opening narrowed coronary arteries. During the study, participants are monitored for major cardiac and cerebrovascular events up to 12 months after randomization. Researchers will collect data on the combined endpoint of these serious events to evaluate the treatments' outcomes. Participants must meet specific eligibility criteria and provide informed consent. The study aims to provide insights into the best treatment approaches for patients with severe coronary artery calcification, with follow-up extending over one year after treatment.