MANTA PSD-109

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.

NCT0290880
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
206-320-2563
206-215-1500