Feasibility and effectiveness of a novel vascular hemostatic device (Chula-clamp) after coronary angiography or percutaneous coronary intervention

Abstract

Background: Chula-clamp is a newly hydraulic vascular hemostatic device. The advantages of the device are convenience, reusability, and lessen patient discomfort and vascular complication. Furthermore, the device is assembled with a recycled balloon inflator and other locally made components, which make it less expensive than other commercially available hemostatic devices. The present study was conducted to compare the effectiveness of Chula-clamp with standard manual compression.

Material and method: This is a prospective, quasi-randomized controlled clinical trial comparing effectiveness of Chula-clamp to conventional manual compression for attaining femoral artery hemostasis after coronary angiography (CAG) or percutaneous coronary intervention (PCI). Effectiveness was determined by femoral vascular complications rate. The primary endpoint was severe femoral vascular complications (the formation of a groin hematoma, femoral artery thrombosis, pseudoaneurysm, and arteriovenous fistula).

Results: One hundred and forty patients scheduled for percutaneous coronary intervention or coronary angiogram in King Chulalongkorn Memorial hospital were enrolled (70 patients for each group). The baseline characteristics were similar in both groups. There was no serious vascular complication detected in either group. In addition, there was no statistical difference in minor complications at the access site between the two groups. [e.g., swelling (1.4% in standard manual compression group vs. 2.9% in Chula-clamp, p = 0.56) and ecchymosis (8.57% in both groups)].

Conclusion: Chula-clamp, a novel hydraulic vascular hemostatic device, is feasible, safe, and effective for femoral artery hemostasis (after CA G or PCI via femoral artery). Its effectiveness is not different from standard manual compression.