Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device - MANTA PSD-051

Essential Medical Inc.0 sites35 target enrollmentTBD

Overview

Trial is onging in other countries

Registry

who.int

Start Date

TBD

End Date

March 22, 2016

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•\* Candidate for non\-emergent transcatheter interventional procedure via a 10\-18F femoral sheath (e.g., transcatheter aortic valve replacement \[TAVR], balloon aortic valvuloplasty \[BAV], abdominal aortic aneurysm \[AAA] stent\-graft placement)
•\* Eligible for sheath removal in the catheterization lab
•\* Age \*18 years
•\* Understand and sign the study specific written informed consent form
•\* Able and willing to fulfill the follow\-up requirements
•\* In the Investigator\*s opinion, the patient is suitable for the MANTA vascular closure device, conventional hemostasis techniques and participation in an investigational trial
•\* Patients of childbearing age with Negative Pregnancy Test within 7 days of procedure

•Baseline exclusions:
•\* Patients who are known to be pregnant or lactating
•\* Patients who are immunocompromised or with pre\-existing autoimmune disease
•\* Patients who have a systemic infection or a local infection at or near the access site
•\* Patients requiring a re\-puncture at a site previously punctured within 48 hours
•\* Patients with significant anemia (hemoglobin \<6\.5 mmol/L, Hematocrit\<30 )
•\* Patients who are morbidly obese or cachectic (BMI \>40 or \<20\)
•\* Patients with Systolic Blood Pressure \>180 mmHg, unless Systolic Pressure can be lowered by pharmacological agents prior to closure
•\* Patients who are currently participating in another clinical trial of an investigational device or drug that has not concluded the follow\-up period
•\* Patients in whom an antegrade puncture is performed or planned