At a glance
ClinicalIndex Comparison Record- ✓Candidate for elective or planned percutaneous transcatheter interventional procedure via retrograde common femoral artery (e.g., TAVI, EVAR, Impella)
- ✓Adequate femoral artery diameter: minimum 5mm for 14F MANTA or 6mm for 18F MANTA per baseline CTA
- ✓Eligible for sheath removal in catheterization lab
- ✓Age ≥21 years
- ✕Pregnant or lactating
- ✕Immunocompromised or with pre-existing autoimmune disease
- ✕Systemic or local infection at/near access site
- ✕Significant anemia: hemoglobin <10 g/dL or hematocrit <30%
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pivotal Clinical Study to EvaluAte the SaFety and Effectiveness of MANTA Vascular Closure Device
In Brief
A clinical study evaluating MANTA vascular closure device for Femoral Arteriotomy Closure. Completed, enrolled 263 participants across 19 sites in 2 countries.
Detailed Summary
Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure. The MANTA device is expected to seal the femoral access puncture in less than 1 minute. This may result in less blood loss and a shorter time to walking compared to alternative closure means. Use of the MANTA device in this study is experimental. All other parts of the procedure involve standard medical care.
Study Details
Timeline
Interventions
The appropriate size of MANTA closure device will be selected and used for the closure of femoral arterial access sites following the use of 10-14F devices or sheaths or the use of 15-18F devices or sheaths.