The purpose of this study is to evaluate the safety and performance of the MANTA Vascular Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular procedures utilizing large bore sheaths for purposes of supporting a CE Mark (Conformite Europeenne--"European Conformity") and other regulatory submissions. The study will assess whether the MANTA VCD is safe and performs as intended for large-bore vascular closure after interventional procedures.
The purpose of this study is to evaluate the safety and performance of MANTA in achieving hemostasis in femoral arterial access sites in patients undergoing percutaneous transcatheter interventional procedures using a 10-18F procedure sheath (such as Transcather Aortic Valve Replacement (TAVR), Balloon Aortic Valvuloplasty (BAV) and Endovascular Aneurysm Repair (EVAR)) for purposes of obtaining a CE Mark in the European Union. The study will evaluate hemostasis success, time to hemostasis and ambulation, treatment success, and the rate of access-site-related complications in comparison to published literature on other hemostasis techniques for closing these large bore punctures (primarily, surgical closure and suture-mediated percutaneous closure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The MANTA device developed by Essential Medical, Inc., is a vascular closure device (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) interventional devices.
San Raffaele Hospital
Milan, Italy
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Number of Participants With Major Complications
Composite endpoint that includes any of the following adverse events: * Access site-related bleeding requiring blood transfusion or vascular repair * Vascular injury requiring repair (e.g. perforation, dissection, arterio-venous fistula, retroperitoneal bleed, pseudoaneurysm) * Femoral artery stenosis at the access site requiring intervention * New ipsilateral lower extremity ischemia causing a threat to the viability of the limb * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization * New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair * Permanent access site-related nerve injury (lasting\>30 days)
Time frame: Within either the first 30 days (plus or minus 7 days) after the procedure or the first 60 days (plus or minus 14 days) after the procedure
Hemostasis Success
Hemostasis at the puncture site within 10 minutes of cutting the MANTA suture without need for manual or mechanical compression and without later re-bleeding (trivial or subcutaneous oozing will not be considered bleeding; light finger pressure to control subcutaneous oozing will not be considered manual compression)
Time frame: Within the first 10 minutes of cutting the MANTA suture
Time to Hemostasis
The elapsed time between MANTA deployment (withdrawal of sheath from artery) and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma).
Time frame: Time between MANTA deployment and first observed and confirmed arterial hemostasis up to ten (10) minutes after MANTA device is deployed.
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