N/A N=66 Diagnostic

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

Endovascular Procedures

Bottom Line

View on ClinicalTrials.gov: NCT03621202 ↗

Enrolled (actual)

Serious AEs

15.0%

Results posted

Dec 2020

Primary outcome: Primary: Cohen's Kappa Coefficient (κ) — 0.84 proportion of agreement

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Saranas Early Bird Bleed Monitoring System (EBBMS) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Saranas, Inc.
Primary completion: Jun 2019

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	—

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

View full record on ClinicalTrials.gov →

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.