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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the use of intracoronary optical coherence tomography OCT guidance compared to angiography-only guidance during percutaneous coronary intervention PCI to treat coronary in-stent restenosis ISR. ISR remains a challenge despite advances in drug-eluting stents, and this trial aims to understand whether OCT can improve acute PCI outcomes by providing more detailed imaging guidance. The study is a randomized, multicenter, non-blinded trial including patients with acute coronary syndrome or stable ischemic heart disease who have ISR requiring PCI. Participants will be randomly assigned to one of two groups PCI guided by OCT plus angiography or PCI guided by angiography alone. In the OCT group, operators perform at least one OCT imaging run before and after PCI and may perform additional OCT runs during the procedure. In the angiography-only group, operators perform PCI guided by angiography, but OCT imaging is also done before and after PCI without the operator seeing the results to allow outcome comparison. Operators use standard PCI tools and techniques at their discretion in both groups. During the study, participants undergo diagnostic angiography followed by PCI with assigned imaging guidance. Researchers will assess the cross-sectional area of the treated coronary segment before and after PCI using imaging techniques. Additional data collected include the number of PCI maneuvers, intracoronary devices used, and quantitative flow ratio values. Participants will be followed for one year to monitor major adverse cardiovascular events. The total participation period includes the PCI procedure and follow-up evaluations up to one year post-procedure.

Age: 18Years - 99YearsAll GendersPhase Not Applicable
12 locations
S

Actively Recruiting

Researchers are studying how best to manage patients with low blood pressure due to traumatic injuries before they reach the hospital. The study focuses on patients helped by helicopter emergency medical services HEMS across Italy, where emergency care practices vary widely. The goal is to understand how prehospital treatments affect hospital recovery and survival, especially for those with severe bleeding and shock. The study observes different prehospital treatments such as drug use including antifibrinolytics, pain relief, sedatives, and muscle relaxants. It also looks at advanced techniques like resuscitative endovascular balloon occlusion of the aorta REBOA, blood transfusions, and ultrasound assessments for trauma. Care strategies like staying on scene for treatment versus rapid transport are also compared as part of usual prehospital management. Participants will have detailed data collected from the prehospital phase including demographics, trauma type, and treatments given. Hospital data such as blood transfusions, lab results, length of hospital and ICU stays, use of ventilation or kidney support, recovery, and survival will be analyzed. The main outcome measured is mortality within 30 days, with secondary outcomes including survival to hospital admission, hospital stay length, blood products used, and transport times. The study started in May 2021 and will continue until May 2026.

Age: 18Years +All Genders
16 locations