Lahr Schwarzwald

Researchers are evaluating the safety and effectiveness of the AGENT Drug-Coated Balloon AGENT DCB compared to the standard care involving drug eluting stent DES andor balloon angioplasty in patients with new de novo coronary artery lesions. The study is prospective, multicenter, open-label, and randomized. It includes a pharmacokinetic PK sub-study and an intravascular ultrasound IVUS sub-study to gather additional data. Participants are assigned to one of several groups based on lesion types such as small vessels, bifurcation side branches, and long lesions. They receive either the AGENT DCB or standard care treatments including drug eluting stents or plain old balloon angioplasty POBA. The study compares these treatments in parallel groups according to the specific lesion characteristics. During the study, participants undergo the assigned procedure followed by protocol-required evaluations and follow-up visits to monitor outcomes. Researchers will assess the primary outcome of target lesion failure rate at 12 months. Participants are monitored for safety and effectiveness, with ongoing assessments throughout the study duration which continues until March 2032.

Researchers are evaluating the use of a new device called the pressure microcatheter to measure the severity of coronary artery lesions in patients with stable coronary artery disease or stabilized non-ST elevation acute coronary syndrome ACS. This trial compares clinical outcomes of patients guided by the pressure microcatheter versus those guided by the conventional pressure wire during percutaneous coronary intervention PCI. The study aims to determine if the pressure microcatheter strategy is not worse than the pressure wire strategy for clinical decision making. Participants will be randomly assigned to receive PCI guided by either the pressure microcatheter or the pressure wire. After an angiographically successful PCI, patients will either undergo fractional flow reserve FFR-guided stent optimization using the assigned device or receive standard care treatment. The interventions are compared in four groups pressure microcatheter with optimization, pressure wire with optimization, pressure microcatheter with standard care, and pressure wire with standard care. Participants will be followed in hospital initially, then at 12 months, and yearly up to five years to monitor clinical outcomes. The study involves collecting data on major adverse cardiac events MACE, procedural times, resource use during hospitalization, post-PCI FFR measurements, and rates of symptoms and complications. This follow-up aims to assess safety, effectiveness, and long-term results of the two guidance strategies.

Researchers are evaluating the safety and efficacy of the SELUTION SLR 014 PTCA Drug Eluting Balloon DEB in treating new lesions in small coronary vessels, specifically those with a reference vessel diameter of 2.00 mm to 2.75 mm. This prospective, randomized controlled, single-blind, multicenter clinical trial aims to support a pre-market approval application to the US FDA. It involves participants with chronic coronary syndrome, unstable angina, or stabilized non-ST elevation myocardial infarction who require percutaneous coronary intervention PCI. Participants will be randomly assigned to one of two groups the experimental group receiving the SELUTION SLR 014 PTCA DEB with lesion preparation following recommended guidelines, or the control group treated with any FDA-approved limus-based drug-eluting stent DES according to standard practice. The study also includes an angiographic substudy with up to 30 additional participants undergoing angiography at 12 months, and a pharmacokinetic substudy with up to 20 participants involving regular blood draws to characterize sirolimus plasma levels. During the trial, participants will undergo lesion preparation and treatment with either the DEB or DES. Follow-up assessments include evaluation of target lesion failure, defined as cardiac death, target-vessel myocardial infarction, or clinically driven target lesion revascularization at 12 months. The pharmacokinetic substudy involves blood sample collection for up to 6 months. Overall, the study involves monitoring safety and effectiveness outcomes, with participant follow-up extending to at least 12 months post-procedure.