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A hydrogel vascular closure device for hemostasis after transfemoral intervention: a randomized controlled clinical
Shuhong Yu1,2, Zhichao Huang1, Zhimai Lyu3
1Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Background:
In this randomized controlled trial we aim to validate the efficacy and safety of a hydrogel vascular closure device (VCD) for hemostasis after transfemoral intervention.
Methods:
Between January and August 2023, 212 patients were enrolled, including 202 in a non-inferiority randomized controlled trial (1:1 hydrogel vs ExoSeal; prespecified margin -10%) and 10 in a hydrogel-only observational arm (8 F). The primary endpoint was device success rate and secondary endpoints including hemostasis time and procedural blood loss.
Results:
Among 102 hydrogel and 100 ExoSeal recipients, hydrogel had non-inferior success rates (99.02% vs 94.00%; 95% CI -0.27% to 11.74%). Hydrogel achieved significantly faster hemostasis (1.99 vs 3.14 min, P<0.001) and reduced blood loss (0.83 mL vs 8.93 mL, P<0.001). No major access site complications were observed in either group. No secondary complications occurred in patients in the experimental group and secondary complications occurred in one patient in the control group (P=0.497). The supplementary cohort of 10 patients supported the efficacy and safety of hydrogel VCD.
Conclusions:
Hydrogel VCD shows non-inferior efficacy to ExoSeal for transfemoral cerebrovascular interventions, with superior hemostatic speed and reduced blood loss while maintaining comparable safety.
Trial Registration Number:
ChiCTR2300068029 (https://www.chictr.org.cn/showproj.html?proj=178962).
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