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

Completed · Not applicable

Conditions studied: Endovascular Procedures

In brief

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.

Key facts

Study ID

NCT03621202

Run by

Saranas, Inc.

People needed

66

Starts

2018-08-13

Expected to finish

2019-06-30

Last updated by the study team

2020-12-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• 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

Where it is running

• North Florida Regional Medical Center — Gainesville, Florida, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Texas Heart Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

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