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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05142566
Study type Interventional
Source Essential Medical, Inc.
Contact
Status Terminated
Phase N/A
Start date August 9, 2022
Completion date January 11, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05936996 - Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
Not yet recruiting NCT06358157 - The Ladera Large Bore Closure Feasibility Study N/A
Completed NCT02521948 - Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device N/A
Completed NCT03330002 - MANTA Registry for Vascular Large-bore Closure
Completed NCT02908880 - MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study N/A
Completed NCT02406612 - X-Seal EU Post-Market Clinical Follow-Up Protocol N/A