MANTA Ultrasound Closure Study (NCT05142566) | Clinical Trial Compass
TerminatedNot Applicable
MANTA Ultrasound Closure Study
Stopped: Ineffective enrollment
United States17 participantsStarted 2022-08-09
Plain-language summary
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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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…
What they're measuring
1
Rate of Any Large Bore Access-site Related VARC-2 Major Vascular Complication