N/A
Completed N=66
Safety and Accuracy of the Saranas EBBMS for the Detection of Endovascular Procedure Related Bleeding Events
Endovascular Procedures
Source: ClinicalTrials.gov NCT03621202 ↗
Enrolled (actual)
66
Serious AEs
15.0%
Results posted
Dec 2020
Primary outcomePrimary: Cohen's Kappa Coefficient (κ) — 0.84 proportion of agreement
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohen's Kappa Coefficient (κ) |
0.84 | — |
| SECONDARY Device Sensitivity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography |
60 | — |
| SECONDARY Device Specificity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography |
75 | — |
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
Data sourced from ClinicalTrials.gov (NCT03621202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.