Essential Medical, Inc.
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.
Femoral Arteriotomy Closure
MANTA Vascular Closure Device
Not Applicable
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 Type : | Interventional |
Estimated Enrollment : | 17 participants |
Masking : | None (Open Label) |
Masking Description : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | Prospective Multicenter MANTA™ Vascular Closure Device Ultrasound Guided Closure Study |
Actual Study Start Date : | August 9, 2022 |
Estimated Primary Completion Date : | January 11, 2023 |
Estimated Study Completion Date : | January 11, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Ultrasound Closure Open label, single arm study using ultrasound guidance during MANTA device deployment. |
Device: MANTA Vascular Closure Device |
Ages Eligible for Study: | 21 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Not yet recruiting
Henry Ford
Detroit, road cancer, United States, 48202
Not yet recruiting
University of Buffalo
Buffalo, New York, United States, 14203
Not yet recruiting
Baylor Scott & White
Round Rock, Texas, United States, 78665
Not yet recruiting
Sentara Northern Virginia Medical Center
Woodbridge, Virginia, United States, 22191
Not yet recruiting
Vancouver General Health
Vancouver, British Columbia, Canada,