Safety and Accuracy of the Saranas EBBMS for the Detection of Endovascular Procedure Related Bleeding Events

Saranas

Status

Completed

Conditions

Endovascular Procedures

Treatments

Device: Saranas Early Bird Bleed Monitoring System (EBBMS)

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT03621202

PVP004

Details and patient eligibility

About

To evaluate the safety and accuracy of the Saranas EBBMS for the detection of access site related internal bleeding events during large-bore endovascular procedures.

Enrollment

66 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥18 years of age
Willing and capable to sign an Informed Consent form
Planned endovascular procedure such as trans-femoral transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty, percutaneous coronary intervention, complex or high-risk percutaneous coronary intervention requiring hemodynamic support device (Impella 2.5, Impella CP, and ECMO), endovascular aortic repair (EVAR), any other endovascular procedures requiring arterial or venous access or surgical insertion of hemodynamic support

Exclusion criteria

Subject is participating, or planning to participate in a clinical trial or study of an investigational product that may influence the data collected for this investigation
Inability to access artery or vein for the endovascular procedure
Current active bleeding
Pre-procedural conditions precluding the realization of a post-procedural CT scan
Pregnancy
Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subject's participation in or ability to complete the study as planned