Clinical trial NCT03621202: Safety and Accuracy of the Saranas EBBMS for the Detection of Endovascular Procedure Related Bleeding Events
Official title: A Clinical Study to Evaluate the Safety and Accuracy of the Saranas Early Bird Bleed Monitoring System for the Detection of Endovascular Procedure Related Bleeding Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endovascular Procedures
Keywords: large bore
femoral access
internal bleeding
retroperitoneal hematoma
bleeding complications
Lead sponsor: Saranas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Proxima CRO
name: Medical Metrics Diagnostics, Inc
First posted: 2018-08-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cohen's Kappa Coefficient (κ)
timeFrame: Up to 8 hours post procedure
Secondary outcomes:
measure: Device Sensitivity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography
timeFrame: Up to 8 hours post procedure
measure: Device Specificity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography
timeFrame: Up to 8 hours post procedure
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
Study officials:
affiliation: Gagnon Cardiovascular Institute, Morristown Medical Center
name: Philippe Genereux, M.D.
role: PRINCIPAL_INVESTIGATOR
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