NCT05142566

MANTA Ultrasound Closure Study

Prospective Multicenter MANTA™ Vascular Closure Device Ultrasound Guided Closure Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Essential Medical, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Demonstrate the safety of MANTA Vascular Closure Device (VCD) ultrasound (U/S) guided closure in patients undergoing elective TAVR procedures with planned percutaneous femoral arterial access.

Detailed description

The MANTA Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures. This study is being conducted to demonstrate the safety of U/S guided closure with MANTA VCD following TAVR procedures utilizing large bore sheaths.

Conditions

• Femoral Arteriotomy Closure

Interventions

Type	Name	Description
DEVICE	MANTA Vascular Closure Device	Evaluate the safety of ultrasound guided deployment of MANTA VCD.

Timeline

• Start date: 2022-08-09
• Primary completion: 2023-01-11
• Completion: 2023-01-11
• First posted: 2021-12-02
• Last updated: 2023-07-27
• Results posted: 2023-07-27

Locations

6 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study