NCT02908880

MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study

Pivotal Clinical Study to EvaluAte the SaFety and Effectiveness of MANTA Vascular Closure Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Essential Medical, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure. The MANTA device is expected to seal the femoral access puncture in less than 1 minute. This may result in less blood loss and a shorter time to walking compared to alternative closure means. Use of the MANTA device in this study is experimental. All other parts of the procedure involve standard medical care.

Detailed description

The MANTA device is a VCD intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F ID) interventional devices. The function of MANTA is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure. The study is being conducted to demonstrate the safety and effectiveness of MANTA in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.

Conditions

• Femoral Arteriotomy Closure

Interventions

Type	Name	Description
DEVICE	MANTA vascular closure device	The appropriate size of MANTA closure device will be selected and used for the closure of femoral arterial access sites following the use of 10-14F devices or sheaths or the use of 15-18F devices or sheaths.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2016-09-21
• Last updated: 2019-09-25
• Results posted: 2019-05-07

Locations

19 sites across 2 countries: United States, Canada