Endovascular ProceduresNCT03621202

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

A study testing Saranas Early Bird Bleed Monitoring System (EBBMS) in people with Endovascular Procedures, run by Saranas, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Endovascular Procedures
What is being tested?: Saranas Early Bird Bleed Monitoring System (EBBMS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 5 sitesUnited States
Study dates: 13 Aug 2018to 30 Jun 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

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

Other trials in United States

About this study

Official title: 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.

Conditions: Endovascular Procedures
Being tested: Saranas Early Bird Bleed Monitoring System (EBBMS)
Keywords: large bore, femoral access, internal bleeding, retroperitoneal hematoma, bleeding complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Saranas Early Bird Bleed Monitoring System (EBBMS)Device
Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.

Study groups in NCT03621202
Study group	Role	What they receive
Saranas Early Bird Bleed Monitoring System (EBBMS)	Experimental	Not described Receives: Device: Saranas Early Bird Bleed Monitoring System (EBBMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Sensitivity measures the proportion of positives bleed detection events that are correctly identified by the EBBMS as compared to post-procedural computerized tomography.
Measured: 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.
Measured: Up to 8 hours post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Aug 201830 Jun 2019

First posted8 Aug 2018
Study start13 Aug 2018
Primary completion30 Jun 2019
Study completion30 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Endovascular ProceduresStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03621202
Sponsor's protocol ID: PVP004
Status last verified: Dec 2020
First submitted: 30 Jul 2018
Last updated: 28 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 24282682
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.
PubMed 21160056
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.
PubMed 13057644
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.
PubMed 2788227
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.
PubMed 11246238
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.
PubMed 14556868
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.
PubMed 17421023
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.
PubMed 14563340
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.
PubMed 20824761
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.
PubMed 15895402
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.
PubMed 7990185
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.
PubMed 8677663
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.
PubMed 15276106
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.
PubMed 1415915

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03621202
Acronym / sponsor ID: PVP004
Conditions: Endovascular Procedures
Keywords: large bore, femoral access, internal bleeding, retroperitoneal hematoma, bleeding complications
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Saranas, Inc.Industry (pharma, biotech, devices)
Collaborators: Proxima CRO, Medical Metrics Diagnostics, Inc
Study start: 13 Aug 2018 (actual)
Primary completion: 30 Jun 2019 (actual)
Study completion: 30 Jun 2019 (actual)
First posted: 8 Aug 2018 (actual)
Results: Posted 28 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Saranas Early Bird Bleed Monitoring System (EBBMS)	Experimental	Device: Saranas Early Bird Bleed Monitoring System (EBBMS)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

≥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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Saranas Early Bird Bleed Monitoring System (EBBMS)Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.	Device	Saranas Early Bird Bleed Monitoring System (EBBMS)

Primary outcome

Cohen's Kappa Coefficient (κ)
Time frame: 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.

2 secondary outcomes

Device Sensitivity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography
Time frame: Up to 8 hours post procedure
Device Specificity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography
Time frame: Up to 8 hours post procedure

Results and safety

Results posted to the registry on 28 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Saranas Early Bird Bleed Monitoring System (EBBMS)	66	60

Primary outcome: Cohen's Kappa Coefficient (κ)

Time frame: Up to 8 hours post procedure. Number. Unit: proportion of agreement

Measure	Saranas Early Bird Bleed Monitoring System (EBBMS) n = 60
Value	0.84

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Saranas Early Bird Bleed Monitoring System (EBBMS)	9 of 60 (15%)	28 of 60 (46.7%)	2 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24282682Nguyen 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.
Background: PubMed 21160056Roger 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.
Background: PubMed 13057644SELDINGER 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.
Background: PubMed 2788227Babu 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.
Background: PubMed 11246238Chandrasekar 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.
Background: PubMed 14556868Kinnaird 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.
Background: PubMed 17421023Yatskar 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.
Background: PubMed 14563340Moscucci 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.
Background: PubMed 20824761Crudu 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.
Background: PubMed 15895402Sherev 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.
Background: PubMed 7990185Kent 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.
Background: PubMed 8677663Fruhwirth J, Pascher O, Hauser H, Amann W. [Local vascular complications after iatrogenic femoral artery puncture]. Wien Klin Wochenschr. 1996;108(7):196-200. German.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philippe Genereux, M.D. principal investigator

Gagnon Cardiovascular Institute, Morristown Medical Center

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Saranas Early Bird Bleed Monitoring System (EBBMS) in people with Endovascular Procedures, run by Saranas, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohen's Kappa Coefficient (κ) (time frame: Up to 8 hours post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03621202, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2020.