Abstract
Introduction and Objective: Semi-compliant (SC) balloons are essential in PCI for lesion preparation before stent deployment. The Optima SC PTCA balloon catheter, a next-generation device, was evaluated in this post-marketing, multicenter study to assess its real-world performance and safety.
Methods: This was a retrospective, observational study conducted across four interventional cardiology centers in India. A total of 183 adult patients with coronary artery disease who underwent PCI with Optima SC balloon pre-dilatation were included. Procedural and device success, adverse events, and operator-assessed device performance were evaluated. Patients were followed up to 3 months, as the time frame was adequate to establish procedural safety and performance of this PTCA catheter.
Results: Device and procedural success were achieved in 179 out of 183 patients (97.8%); failure in 2.2% was reported in complex lesions. No major adverse cardiac events (MACE), serious adverse events (SAE), or device-related complications were reported during hospital stay, though two clinical events (angina and target lesion failure) were reported in two patients during follow-up. Operator assessment rated performance satisfactory or better in >90% of cases across all parameters.
Conclusion: The Optima SC semi-compliant PTCA balloon catheter demonstrated a high procedural success rate and an excellent short-term safety profile in a real-world clinical setting. These findings support its use as a reliable and effective tool for coronary lesion pre-dilatation during PCI.
Keywords
Percutaneous coronary intervention, Coronary artery disease, Lesion preparation, Semi-compliant balloon, Balloon catheter, Optima SC, Device safety