MANTA Ultrasound Closure Study

Stopped early · Not applicable

Conditions studied: Femoral Arteriotomy Closure

In brief

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.

Key facts

Study ID

NCT05142566

Run by

Essential Medical, Inc.

People needed

17

Starts

2022-08-09

Expected to finish

2023-01-11

Last updated by the study team

2023-07-27

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter valve replacement (TAVR) via a 10-20F device or sheath (12-25F OD) with common femoral artery approach
• Vessel size would allow for access for the MANTA VCD based on vessel size as determined by baseline CTA: minimum vessel diameter of 5mm for the 14F MANTA VCD and 6mm for the 18F MANTA VCD
• Understand and sign the study specific written informed consent form and PHI authorization
• Able and willing to fulfill the follow-up requirements

You may not qualify if…

• Patients known to be pregnant or lactating
• Patients who have a systemic infection or a local infection at or near the access site
• Patients with significant anemia (hemoglobin ≤10 g/DL)
• Patients who are morbidly obese or cachectic (BMI >40 or <20kg/m2)
• Patients with a known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
• Patients with allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel
• Patients with a femoral artery puncture in target groin within the prior 30 days, prior vascular closure device placement in the target common femoral artery within 3 months, or any prior target femoral artery access-related complication
• Patients who have undergone use of an intra-aortic balloon pump (IABP) through the arterial access site within 30 days prior to the baseline evaluation.
• Patients who have a Common Femoral Artery (CFA) with visible calcium and/or tortuosity, as determined by baseline CTA, precluding safe access and likely to interact with large bore access site arteriotomy, determined by investigator.
• Patients with previous iliofemoral intervention in region of access site, including but not limited to prior atherectomy, stenting, surgical or grafting procedures in the access area
• Patients in whom oral anticoagulation therapy cannot be stopped for the peri procedural period or patients with INR >1.8 at the time of the procedure
• Patients who are unable to ambulate at least 6 meters without assistance at baseline
• Patients with renal insufficiency (serum creatinine >2.5 mg/dl) or on dialysis therapy
• Patients with existing nerve damage in the ipsilateral leg
• Patients with a further planned endovascular procedure within the next 30 days
• Patients who have already participated in this IDE study
• Patients who are currently participating in another clinical study of an unapproved investigational device or drug that has not concluded the follow-up period or patient currently participating in another clinical study likely to influence hemostasis and vascular complications
• Patients who cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease
• Patients who have a common femoral artery <5mm in diameter for the 14F MANTA VCD or <6 mm in diameter for the 18F MANTA VCD, common femoral artery stenosis resulting in a vessel diameter <5mm in diameter for the 14F MANTA VCD or <6 mm in diameter for the 18F MANTA VCD, or > 50% diameter femoral or iliac artery stenosis
• Patients in whom, during initial access of the artery, arteriotomy and surrounding anatomy cannot be visualized and identified clearly under U/S imaging and/or if the vertical depth from the surface of the skin to target area of the common femoral artery measures greater than 6cm

Where it is running

• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Henry Ford — Detroit, Michigan, United States
• University of Buffalo — Buffalo, New York, United States
• Baylor Scott & White — Round Rock, Texas, United States
• Sentara Northern Virginia Medical Center — Woodbridge, Virginia, United States
• Vancouver General Health — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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