NCT07279220

Safety and Effectiveness of the Vascular Closure Device for Femoral Artery Hemostasis in Patients of Femoral Artery Puncture

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Effectiveness of the Vascular Closure Device for Femoral Artery Hemostasis in Patients of Femoral Artery Puncture

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Shanghai Bomaian Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to verify the safety and effectiveness of the Vascular Closure Device manufactured by Shanghai Bomaian Medical Technology Co., Ltd. for femoral artery hemostasis in patients of femoral artery puncture.

Conditions

• Femoral Artery Puncture
• Vascular Closure Device
• Hemostasis

Interventions

Type	Name	Description
DEVICE	Vascular Closure Device Manufactured by Shanghai Bomaian Medical Technology Co., Ltd.	The test group will use the Vascular Closure Device manufactured by Shanghai Bomaian Medical Technology Co., Ltd. for femoral artery hemostasis in patients of femoral artery puncture
DEVICE	MynxGrip Vascular Closure Device Manufactured by Cordis US Corp	The control group will use MynxGrip Vascular Closure Device Manufactured by Cordis US Corp for femoral artery hemostasis in patients of femoral artery puncture

Timeline

• Start date: 2025-12-29
• Primary completion: 2026-03-02
• Completion: 2026-05-15
• First posted: 2025-12-12
• Last updated: 2025-12-12

Locations

1 site across 1 country: China