To demonstrate the safety and effectiveness of MANTA 14F and 18F Vascular Closure Devices in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.

Heart & Vascular, Heart & Vascular - Interventional Cardiology Trials
Ming Zhang, MD
Essential Medical, Inc.
Matt Ormond

Key Inclusion Criteria

  • Candidate for elective or planned percutaneous transcatheter interventional procedure via a 10-18F size retrograde common femoral artery approach (i.e. TAVR, EVAR, Impella use)
  • Vessel size allows for access for MANTA device as determined by baseline CTA (minimum vessel diameter 5mm for 14F MANTA and 6mm for 18F MANTA)
  • Eligible for sheath removal in the catheterization lab
  • Age greater than or equal to 21 year

Baseline Exclusion Criteria

  • Known to be pregnant or lactating
  • Immunocompromised or with a pre-existing autoimmune disease
  • Systemic infection or local infection at or near the access site
  • Known bleeding disorder including thrombocytopenia, thrombasthenia, hemophilia or von Willebrand disease
  • Allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel
  • Femoral artery puncture in target groin within the prior 14 days, recent femoral artery puncture in target groin that has not healed appropriately, and/or prior vascular closure device placement in target common femoral artery that the investigator determines may interfere with the MANTA device
  • Common femoral artery with calcium
  • Previous iliofemoral intervetion in region of access site
  • Patients who have undergone use of an intra-aortic balloon pump through the arterial access within 30 days
  • Undergoing therapeutic thrombolysis
  • Patients in whom oral anticoagulation therapy cannot be stopped for the peri-procedural period or patients with INR >1.8 at time of procedure.
  • Patients unable to be adequately anti-coagulated for the procedure
  • Patients who are not mobile and are confined to a wheelchair or bed
  • ST-elevation MI within 30 days or ACS less than or equal to 48 hrs before procedure
  • NYHA Class IV heart failure
  • Left Ventricular Ejection Fraction < 20%
  • Unilateral or bilateral lower extremity amputation
  • Renal insufficieny or on dialysis therapy
  • Existing nerve damage in the ipsilateral leg
  • Further planned endovascular procedure within 30 days

Further Intra-Procedure Exclusions Apply

Matt Ormond