Endovascular Procedures
Conditions
Keywords
large bore, femoral access, internal bleeding, retroperitoneal hematoma, bleeding complications
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.
Interventions
DEVICESaranas Early Bird Bleed Monitoring System (EBBMS)
Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.
Sponsors
Proxima CRO
Medical Metrics Diagnostics, Inc
Saranas, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Saranas Early Bird Bleed Monitoring System (EBBMS) Saranas Early Bird Bleed Monitoring System (EBBMS): Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Saranas Early Bird Bleed Monitoring System (EBBMS) |
|---|---|
| Age, Continuous | 76 years STANDARD_DEVIATION 10 |
| Atrial Fibrillation | 17 Participants |
| Body Mass Index (BMI) | 28 kg/m^2 STANDARD_DEVIATION 6 |
| Diabetes | 25 Participants |
| Hypertension | 37 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 57 Participants |
| Renal Insufficiency | 7 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 60 |
| other Total, other adverse events | 28 / 60 |
| serious Total, serious adverse events | 9 / 60 |
Outcome results
Primary
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.
Time frame: Up to 8 hours post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saranas Early Bird Bleed Monitoring System (EBBMS) | Cohen's Kappa Coefficient (κ) | 0.84 proportion of agreement |
Secondary
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.
Time frame: Up to 8 hours post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Saranas Early Bird Bleed Monitoring System (EBBMS) | Device Sensitivity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography | 60 Participants |
Secondary
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.
Time frame: Up to 8 hours post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saranas Early Bird Bleed Monitoring System (EBBMS) | Device Specificity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography | 75 Percentage |