Document Type : Original Article
Authors
1 Head- Medical Division
2 Medical Division, Sahajanand Laser Technology Limited, Gandhinagar, Gujarat
3 Interventional Cardiologist, Maharaja Agrasen Hospital, Fulbari Truck Terminus, Dist, Siliguri, West Bengal 734015
4 Interventional Cardiologist, North Bengal Neuro Centre Multispeciality Hospital, Maghnad Saha Sarani, Ward 2, Pradhan Nagar, Siliguri, West Bengal, 734003
Abstract
Background: The present post-marketing clinical study was conducted at a follow-up period of 12-month to monitor the clinical outcome of patients who had been treated with Vector® Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter for 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.
Aim: This investigation aimed to assess the safety and effectiveness of Vector® PTCA Balloon Catheter in real-world settings.
Methods: A 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).
Results: The Vector® PTCA Balloon Catheter has shown promising results in a small group of patients undergoing dilatation of normal and intricate coronary artery lesions and reflected with 100% procedural success rate. The successful delivery to the target lesion, deployment, and subsequent retrieval of the device during the index procedure lead to 100% device success rate without any technical issues. A total of 4 (3.2%) patients experienced MACE during 12-month with 2 (1.6%) MI, 2 (1.6%) TLR, and no cardiovascular death.
Conclusions: This study demonstrated the favorable safety and reliability of 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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