A Prospective Multicenter Study Using a Virtual 3 Fr Percutaneous Coronary Intervention System: The V3 Registry

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• Small-diameter guiding catheters (GCs) enable less-invasive percutaneous coronary intervention (PCI).
• The virtual 3 Fr (V3) system represents an extremely slender PCI option.
• Outcomes associated with the V3 system required further investigation.

Purpose of the Study:

• To assess the safety and feasibility of the virtual 3 Fr (V3) sheathless percutaneous coronary intervention (PCI) system.
• To determine the clinical and procedural success rates of V3 PCI.
• To evaluate adverse events, including major adverse cardiac and cerebrovascular events (MACCE) and access-site complications.

Main Methods:

• Prospective, multicenter, non-randomized V3 registry study.
• Enrolled patients undergoing elective V3 PCI.
• Primary endpoint: clinical success rate; Secondary endpoints: PCI success rate, MACCE at 30 days, access-site complications.

Main Results:

• 260 patients (321 lesions) enrolled; 70% male, mean age 70.8 years.
• Clinical success rate: 95.8%; PCI success rate: 99.2%.
• No MACCE reported; 12.7% experienced access-site hematoma; 0.4% radial artery occlusion.

Conclusions:

• Percutaneous coronary intervention (PCI) using the V3 system is safe and feasible.
• Extremely low rates of radial artery occlusion and major bleeding were observed.
• Access-site hematoma was a frequent complication, particularly during catheter exchange.