ArticleARYA atherosclerosis2024
Clinical performance and safety of the Vector® percutaneous transluminal coronary angioplasty balloon catheter: A single-arm, multicenter, retrospective post-marketing clinical study.
Article in ARYA atherosclerosis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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4 authors.
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Abstract
backgroundThe present post-marketing clinical study was conducted over a 12-month follow-up period to monitor the clinical outcomes of patients treated with the Vector® Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter for the dilatation of coronary lesions. The semi-compliant balloon improves balloon-to-vessel wall apposition and minimizes balloon slippage during PTCA, which could reduce complications and improve clinical outcomes. This investigation aimed to assess the safety and effectiveness of the Vector® PTCA Balloon Catheter in real-world settings.
methodsA retrospective study was conducted to investigate the safety and efficacy of the Vector® PTCA Balloon Catheter in 125 patients who underwent pre-dilatation and post-dilatation. The primary outcome of the study was major adverse cardiac events (MACE), a composite endpoint encompassing target-lesion revascularization (TLR), cardiac death, and myocardial infarction (MI).
resultsThe Vector® PTCA Balloon Catheter has shown promising results in a small group of patients undergoing dilatation of normal and intricate coronary artery lesions, reflecting a 100% procedural success rate. The successful delivery to the target lesion, deployment, and subsequent retrieval of the device during the index procedure led to a 100% device success rate without any technical issues. A total of 3.2% (4) patients experienced MACE during the 12-month follow-up, with 1.6% (2) MI, 1.6% (2) TLR, and no cardiovascular deaths..
conclusionThis study demonstrated the favorable safety and reliability of the Vector® PTCA Balloon Catheter in patients with angina, MI, and a history of coronary artery disease in a real-world setting.
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