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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Endovascular Procedures

Intervention / Treatment
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* Device: Saranas Early Bird Bleed Monitoring System (EBBMS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saranas Early Bird Bleed Monitoring System (EBBMS)<br> | Device: Saranas Early Bird Bleed Monitoring System (EBBMS)<br>* Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohen's Kappa Coefficient (κ) | Statistic measures concordance in detecting bleeds between the Saranas EBBMS and post-procedural CT. Cohen suggested the Kappa result be interpreted as follows: values ≤ 0 as indicating no agreement and 0.01-0.20 as none to slight, 0.21-0.40 as fair, 0.41- 0.60 as moderate, 0.61-0.80 as substantial, and 0.81-1.00 as almost perfect agreement. | Up to 8 hours post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Sensitivity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography | Sensitivity measures the proportion of positives bleed detection events that are correctly identified by the EBBMS as compared to post-procedural computerized tomography. | Up to 8 hours post procedure | 
| Device Specificity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography | Specificity relates to the EBBMS' ability to correctly reject non-bleeding events as compared to post-procedural computerized tomography. | Up to 8 hours post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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large bore, femoral access, internal bleeding, retroperitoneal hematoma, bleeding complications