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

NCT03621202 | Completed Results FDA Device

• 1 other identifier: PVP004
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 5

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.

Conditions

Endovascular Procedures

Keywords

large bore; femoral access; internal bleeding; retroperitoneal hematoma; bleeding complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Device Sensitivity in Bleeding Detection of the Saranas 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

  Up to 8 hours post procedure

Study Arms (1)

Saranas Early Bird Bleed Monitoring System (EBBMS)

EXPERIMENTAL

Device: Saranas Early Bird Bleed Monitoring System (EBBMS)

Interventions

Saranas Early Bird Bleed Monitoring System (EBBMS) DEVICE

Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.

Saranas Early Bird Bleed Monitoring System (EBBMS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saranas, Inc.: lead
• Proxima CRO: collaborator
• Medical Metrics Diagnostics, Inc: collaborator

Study Sites (5)

North Florida Regional Medical Center

Gainesville, Florida, 32605, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

Related Publications (14)

• 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.

  PMID: 24282682 BACKGROUND

• 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.

  PMID: 21160056 BACKGROUND

• SELDINGER SI. Catheter replacement of the needle in percutaneous arteriography; a new technique. Acta Radiol (Stockh). 1953 May;39(5):368-76. doi: 10.3109/00016925309136722. No abstract available.

  PMID: 13057644 BACKGROUND

• 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.

  PMID: 2788227 BACKGROUND

• 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.

  PMID: 11246238 BACKGROUND

• 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.

  PMID: 14556868 BACKGROUND

• 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.

  PMID: 17421023 BACKGROUND

• 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.

  PMID: 14563340 BACKGROUND

• 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.

  PMID: 20824761 BACKGROUND

• 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.

  PMID: 15895402 BACKGROUND

• 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.

  PMID: 7990185 BACKGROUND

• 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.

  PMID: 8677663 BACKGROUND

• 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.

  PMID: 15276106 BACKGROUND

• 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.

  PMID: 1415915 BACKGROUND

Results Point of Contact

• Title: Zaffer Syed
• Organization: Saranas, Inc.

zaffer@saranas.com

833-375-9273

Study Officials

• Philippe Genereux, M.D.

  Gagnon Cardiovascular Institute, Morristown Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 8, 2018
• Study Start: August 13, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: December 28, 2020
• Results First Posted: December 28, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)