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Found 2 Actively Recruiting clinical trials
Actively Recruiting
This research focuses on patients who have experienced ST segment elevation myocardial infarction STEMI and require percutaneous coronary intervention PCI. The study compares two approaches a shorter duration of dual antiplatelet therapy DAPT with Prasugrel followed by Prasugrel monotherapy versus the standard one-year DAPT regimen. Additionally, in patients with multivessel disease MVD, the trial evaluates the effectiveness and safety of complete revascularization guided by either Optical Coherence Tomography OCT or angiography. Participants receive a loading dose of aspirin and Prasugrel at the time of PCI, treating the culprit lesion first. For those with MVD, non-culprit lesions are treated in staged procedures within 15 days. Following 30 to 45 days after the initial procedure, eligible patients are randomized to either continue short DAPT with Prasugrel monotherapy or follow the standard 12-month DAPT. Complete revascularization in MVD patients is further randomized to OCT-guided or angiography-guided strategies. Participants will be followed clinically for 35 months after randomization to monitor outcomes, with key assessments at 11 and 35 months. Researchers will measure safety and efficacy endpoints, including major adverse cardiac and cerebrovascular events and bleeding events. The study includes detailed monitoring of treatment adherence, successful revascularization, and clinical events to evaluate the comparative benefits of the treatment strategies.
Actively Recruiting
Researchers are evaluating the effectiveness, safety, and economic benefits of coronary lithotripsy compared to other lesion preparation methods like cutting or super high pressure balloon angioplasty and ablative procedures. The study focuses on treatment of severely calcified coronary artery stenoses in patients with coronary artery disease. It is a randomized, double-blind trial sponsored by Deutsches Herzzentrum Muenchen. Participants receive lesion preparation either by intravascular lithotripsy using balloons with a rated burst pressure of up to 18 atm or by other standard methods such as high, super high, cutting balloons, and ablative techniques. These procedures are performed before intracoronary stenting. The trial compares these approaches to assess additional benefits in treating severely calcified coronary lesions. During the study, participants are monitored for major cardiac and cerebrovascular events over 12 months after randomization. Researchers also track mortality, myocardial infarction, stroke, need for vessel revascularization, stent thrombosis, hospitalization for acute coronary syndrome, and bleeding events. Symptom assessments for physical and mental health related to coronary heart disease and medical costs are also evaluated. Safety and procedural success are closely observed throughout the study period.