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

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

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.

Study Overview

• Status: Completed
• Conditions: Endovascular Procedures
• Intervention / Treatment: Device: Saranas Early Bird Bleed Monitoring System (EBBMS)

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32605
      • North Florida Regional Medical Center
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77030
      • Texas Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Saranas Early Bird Bleed Monitoring System (EBBMS)	Device: Saranas Early Bird Bleed Monitoring System (EBBMS); Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Saranas, Inc.
• Collaborators: Proxima Clinical Research; Medical Metrics Diagnostics, Inc
• Investigators: Principal Investigator: Philippe Genereux, M.D., Gagnon Cardiovascular Institute, Morristown Medical Center

Publications and helpful links

General Publications

• Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15. Erratum In: Circulation. 2011 Feb 15;123(6):e240. Circulation. 2011 Oct 18;124(16):e426.
• Moscucci M, Fox KA, Cannon CP, Klein W, Lopez-Sendon J, Montalescot G, White K, Goldberg RJ. Predictors of major bleeding in acute coronary syndromes: the Global Registry of Acute Coronary Events (GRACE). Eur Heart J. 2003 Oct;24(20):1815-23. doi: 10.1016/s0195-668x(03)00485-8.
• Kinnaird TD, Stabile E, Mintz GS, Lee CW, Canos DA, Gevorkian N, Pinnow EE, Kent KM, Pichard AD, Satler LF, Weissman NJ, Lindsay J, Fuchs S. Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions. Am J Cardiol. 2003 Oct 15;92(8):930-5. doi: 10.1016/s0002-9149(03)00972-x.
• Nguyen CT, Lee E, Luo H, Siegel RJ. Echocardiographic guidance for diagnostic and therapeutic percutaneous procedures. Cardiovasc Diagn Ther. 2011 Dec;1(1):11-36. doi: 10.3978/j.issn.2223-3652.2011.09.02.
• SELDINGER SI. Catheter replacement of the needle in percutaneous arteriography; a new technique. Acta radiol. 1953 May;39(5):368-76. doi: 10.3109/00016925309136722. No abstract available.
• Babu SC, Piccorelli GO, Shah PM, Stein JH, Clauss RH. Incidence and results of arterial complications among 16,350 patients undergoing cardiac catheterization. J Vasc Surg. 1989 Aug;10(2):113-6. doi: 10.1067/mva.1989.0100113.
• Chandrasekar B, Doucet S, Bilodeau L, Crepeau J, deGuise P, Gregoire J, Gallo R, Cote G, Bonan R, Joyal M, Gosselin G, Tanguay JF, Dyrda I, Bois M, Pasternac A. Complications of cardiac catheterization in the current era: a single-center experience. Catheter Cardiovasc Interv. 2001 Mar;52(3):289-95. doi: 10.1002/ccd.1067.
• Yatskar L, Selzer F, Feit F, Cohen HA, Jacobs AK, Williams DO, Slater J. Access site hematoma requiring blood transfusion predicts mortality in patients undergoing percutaneous coronary intervention: data from the National Heart, Lung, and Blood Institute Dynamic Registry. Catheter Cardiovasc Interv. 2007 Jun 1;69(7):961-6. doi: 10.1002/ccd.21087.
• Crudu V, Blankenship J, Berger P, Scott T, Skelding K. Complications related to access site after percutaneous coronary interventions: are the adverse events underreported? Catheter Cardiovasc Interv. 2011 Apr 1;77(5):643-7. doi: 10.1002/ccd.22759. Epub 2011 Mar 8.
• Sherev DA, Shaw RE, Brent BN. Angiographic predictors of femoral access site complications: implication for planned percutaneous coronary intervention. Catheter Cardiovasc Interv. 2005 Jun;65(2):196-202. doi: 10.1002/ccd.20354.
• Kent KC, Moscucci M, Mansour KA, DiMattia S, Gallagher S, Kuntz R, Skillman JJ. Retroperitoneal hematoma after cardiac catheterization: prevalence, risk factors, and optimal management. J Vasc Surg. 1994 Dec;20(6):905-10; discussion 910-3. doi: 10.1016/0741-5214(94)90227-5.
• Fruhwirth J, Pascher O, Hauser H, Amann W. [Local vascular complications after iatrogenic femoral artery puncture]. Wien Klin Wochenschr. 1996;108(7):196-200. German.
• Berry C, Kelly J, Cobbe SM, Eteiba H. Comparison of femoral bleeding complications after coronary angiography versus percutaneous coronary intervention. Am J Cardiol. 2004 Aug 1;94(3):361-3. doi: 10.1016/j.amjcard.2004.04.036.
• Khoury M, Batra S, Berg R, Rama K, Kozul V. Influence of arterial access sites and interventional procedures on vascular complications after cardiac catheterizations. Am J Surg. 1992 Sep;164(3):205-9. doi: 10.1016/s0002-9610(05)81071-2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 13, 2018
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (ACTUAL): August 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 28, 2020
• Last Update Submitted That Met QC Criteria: December 24, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: large bore; femoral access; internal bleeding; retroperitoneal hematoma; bleeding complications
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: PVP004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No