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

Not Applicable

Completed

• Conditions: Endovascular Procedures
• Interventions: Device: Saranas Early Bird Bleed Monitoring System (EBBMS)

• Registration Number: NCT03621202
• Lead Sponsor: Saranas, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-08-03
• Study First Posted: 2018-08-08
• Study Start: 2018-08-13
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Results First Submitted: 2020-08-18
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-24
• Last Update Submitted: 2020-12-24
• Results First Posted: 2020-12-28
• Last Update Posted: 2020-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Saranas Early Bird Bleed Monitoring System (EBBMS)	Saranas Early Bird Bleed Monitoring System (EBBMS)	-

Primary Outcome Measures

Name	Time	Method
Cohen's Kappa Coefficient (κ)	Up to 8 hours post procedure	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.

Secondary Outcome Measures

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

Trial Locations

Locations (5)

North Florida Regional Medical Center; 🇺🇸 Gainesville, Florida, United States

Morristown Medical Center; 🇺🇸 Morristown, New Jersey, United States

Texas Heart Institute; 🇺🇸 Houston, Texas, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States