Cardiac ArrestEarly Phase 1REVAMPNCT03703453
Resuscitative EndoVascular Aortic Occlusion for Maximal Perfusion
A Early Phase 1 study testing ER-REBOA catheter in people with Cardiac Arrest, run by Yale University at 1 site in United States.
Trial summary
REBOA is an endovascular technique that is becoming more widely used in the setting of severe trauma. It is a procedure where one uses the seldigner technique to advance a balloon tipped catheter into the femoral artery and then into the aorta. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- ER-REBOA catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2020to 29 Apr 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have had a witnessed cardiac arrest2 of suspected medical etiology
- CPR initiation within approximately 6 minutes of collapse (as estimated based on history provided by EMS), either by EMS, hospital personnel, or a bystander
Who cannot join
- Known active terminal illness or severe dementia
- Known aortic disease
- Age 80 or older
- Total resuscitation time greater than approximately 45 minutes (from start of CPR)
- Age less than 18
- Wards of the state
Show all 10Show fewer
- Known or suspected (by physical exam or history) pregnancy
- Suspected traumatic cause of cardiac arrest
- Known Do Not Resuscitate (DNR) orders
- Anticipated difficult procedure (e.g. signs of peripheral vascular disease, severe obesity, or otherwise deemed likely to be difficult by enrollment staff)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06519
About this study
Official title: The Use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) as an Adjunct to Advanced Cardiac Life Support in Non-traumatic Cardiac Arrest: an Early Feasibility Trial
REBOA is an endovascular technique that is becoming more widely used in the setting of severe trauma. It is a procedure where one uses the seldigner technique to advance a balloon tipped catheter into the femoral artery and then into the aorta. The balloon is then inflated to fully occlude blood flow to the distal aorta.
Study investigators hypothesize that this technique may be of use in the setting of medical cardiac arrest. By occluding the aorta and preventing distal blood flow during CPR, physicians might maximize perfusion to the heart and the brain, and promote return of spontaneous circulation and neurologic recovery.
Investigators plan to conduct an IDE approved early feasibility study using the ER-REBOA catheter in five patients who are in cardiac arrest of medical (i.e. non-traumatic) etiology. The primary outcomes will be feasibility and safety. Secondary outcomes will focus on procedural performance, hemodynamic response to aortic occlusion, and patient-centered outcome variables. Investigators plan to expand the study to an additional 15 patients if, after the initial five patients, the risk-benefit profile remains favorable.
Read the detailed description
The proposed study will assess the safety, feasibility, and efficacy of the use of the ER-REBOA™ catheter as a means of increasing cardio-cerebral perfusion in medical cardiac arrest patients. The ER-REBOA™ catheter is a device that has been gaining increased use in the setting of severe trauma for the purposes of stopping intra-abdominal hemorrhage. The catheter is advanced through a femoral artery sheath into the aorta, where a balloon at its tip is inflated, occluding all distal blood flow (and stopping any hemorrhage while the patient can be prepared for definitive operative intervention).
Dr. Daley (along with previous investigators) has hypothesized that by using the device to occlude distal blood flow during medical cardiac arrest, one might increase the perfusion to the brain and heart, maximizing the patient's chance for cardiac and neurologic recovery. Aortic occlusion for medical cardiac arrest is supported by robust pre-clinical literature, but has not yet been studied in humans.
The proposed study is divided into two phases, with a different primary outcome in each phase. Phase 1 of the study is expected to occur over a period of 1 year. Phase 2 expected duration is 1.5 years. Each phase of the study will require separate FDA/IRB approval. Enrollment will take place at Yale-New Haven Hospital in New Haven, CT, the primary site for Phase 1 and Phase 2 of the study. A potential secondary site, the University of California, Davis, has been approved for trial participation but will not contribute to enrollment during Phase 1.
Phase 1 will primarily examine the feasibility and safety of the use of the ER-REBOA catheter in five non-traumatic cardiac arrest patients. If deemed feasible and safe, the PI will request permission from the FDA and the IRB to expand the study to Phase 2. Phase 2 will consist of the enrollment of a subsequent 15 patients (20 in total for both phase 1 and 2) with a primary focus on procedural performance, hemodynamic response to aortic occlusion, and patient-centered outcome variables. Per our hypothesis, if the ER-REBOA catheter is efficacious in medical cardiac arrest patients, an increase in systolic and diastolic blood pressure should be evident after the inflation of the intra-aortic balloon. Phase 2 will utilize the built in continuous arterial blood pressure monitoring capabilities of the device to assess for a significant blood pressure increase after the deployment of the aortic balloon.
- Conditions
- Cardiac Arrest
- Being tested
- ER-REBOA catheter
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ER-REBOA catheterDevice
The ER-REBOA™ catheter is a device that has been gaining increased use in the setting of severe trauma for the purposes of stopping intra-abdominal hemorrhage. The catheter is advanced through a femoral artery sheath into the aorta, where a balloon at its tip is inflated, occluding all distal blood flow (and stopping any hemorrhage while the patient can be prepared for definitive operative intervention).
| Study group | Role | What they receive |
|---|---|---|
| REBOA | Experimental | Patients undergoing REBOA for medical cardiac arrest Receives: Device: ER-REBOA catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of aortic occlusion
The successful inflation of the aortic balloon at the level of the diaphragm with resultant occlusion of aortic blood flow. The procedure will be considered feasible if aortic balloons are deployed at the level of the diaphragm in at least 70% of patients attempted. The location of the balloon will be confirmed with bedside ultrasound and/or X-ray. Successful aortic occlusion will be confirmed using flow measurements on bedside ultrasound as well as detecting a lack of blood pressure distal to the aortic balloon using a pressure transducer in the femoral artery.
Measured: The time expected for the procedure typically take between 10 and 15 minutes.
Safety of Procedure
Safety is defined by a composite prevalence of five pre-specified adverse events.
•Composite events: blood vessel damage requiring intervention, arterial thromboembolism, lower extremity amputation, renal failure requiring non-temporary dialysis, lower extremity paralysis
Measured: Time of procedure to 90-days post-discharge
Secondary outcomes (13)
Time from first needle stick to sheath insertion
Procedural
Measured: Time of micropuncture needle first insertion into common femoral artery until successful 7 French (Fr) sheath insertion into common femoral artery
Time from first needle stick to Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) balloon inflation
Procedural
Measured: Time when micropuncture needle first insertion into common femoral artery until REBOA catheter balloon successfully inflated with 8 cc saline
Number of needle sticks required for sheath insertion
Procedural
Measured: Time from first micropuncture needle stick until successful insertion of 7 Fr sheath into common femoral artery up to 30 minutes
Change in systolic blood pressure after aortic occlusion
Hemodynamic
Measured: 1 minutes before and 15 minutes after aortic occlusion
Change in diastolic blood pressure after aortic occlusion
Hemodynamic
Measured: 1 minute before and 15 minutes after aortic occlusion
Change in end tidal carbon dioxide after aortic occlusion
Hemodynamics
Measured: 1 minute before and 15 minutes after aortic occlusion
Change in oxygen saturation from pulse oximeter
Hemodynamics
Measured: 1 minute before and 15 minutes after aortic occlusion
Change in coronary perfusion pressure
Hemodynamics
Measured: 1 minute before and 15 minutes after aortic occlusion
Change in Electrocardiogram (ECG) patterns
Hemodynamics
Measured: 1 minute before and 15 minutes after aortic occlusion
Neurologic function at 30 and 90 days
Measured by Modified Rankin Scale (mRS) and Cerebral Performance Category (CPC).
The mRS can help users determine the degree of disability in patients who have suffered a stroke or other causes of neurological disability by measuring the degree of disability or dependence in the daily activities of people. An mRS of a patient is compared over time to check for recovery and degree of continued disability. A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death. The mRS has been used in clinical research for over 30 years and is a common standard for assessing functional outcomes in patients. Multiple studies have shown that the mRS correlates with physiological indicators for neurological impairment.
The CPC score is the most commonly used tool to assess this for both research and audit purposes. Most studies define a good outcome as a CPC score of 1 or 2, and a poor outcome (severe neurological disability, persistent vegetative state or
Measured: 30 and 90 days post enrollment
Rate of return of spontaneous circulation (ROSC)
Patient Oriented
Measured: Arrival in ED to sustained ROSC or death, assessed up to 1 hour
Rate of Intensive Care Unit (ICU) Admission
Patient Oriented
Measured: Death in ED or admission to ICU post sustained ROSC, assessed up to 24 hours
Length of stay in ICU and total length of hospitalization
Patient Oriented
Measured: Time of admission in ICU to discharge or death, assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start28 Jan 2020
- Primary completion29 Apr 2021
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- REBOA in medical cardiac arrest patients
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James I. Daley, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703453
- Sponsor's protocol ID
- 2000023899
- Acronym
- REVAMP
- Status last verified
- Aug 2021
- First submitted
- 9 Oct 2018
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Daley J, Morrison JJ, Sather J, Hile L. The role of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct to ACLS in non-traumatic cardiac arrest. Am J Emerg Med. 2017 May;35(5):731-736. doi: 10.1016/j.ajem.2017.01.010. Epub 2017 Jan 12.
PubMed 28117180
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) as an Adjunct to Advanced Cardiac Life Support in Non-traumatic Cardiac Arrest: an Early Feasibility Trial
- ClinicalTrials.gov ID
- NCT03703453
- Acronym / sponsor ID
- REVAMP / 2000023899
- Conditions
- Cardiac Arrest
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
REBOA is an endovascular technique that is becoming more widely used in the setting of severe trauma. It is a procedure where one uses the seldigner technique to advance a balloon tipped catheter into the femoral artery and then into the aorta. The balloon is then inflated to fully occlude blood flow to the distal aorta.
Study investigators hypothesize that this technique may be of use in the setting of medical cardiac arrest. By occluding the aorta and preventing distal blood flow during CPR, physicians might maximize perfusion to the heart and the brain, and promote return of spontaneous circulation and neurologic recovery.
Investigators plan to conduct an IDE approved early feasibility study using the ER-REBOA catheter in five patients who are in cardiac arrest of medical (i.e. non-traumatic) etiology. The primary outcomes will be feasibility and safety. Secondary outcomes will focus on procedural performance, hemodynamic response to aortic occlusion, and patient-centered outcome variables. Investigators plan to expand the study to an additional 15 patients if, after the initial five patients, the risk-benefit profile remains favorable.
Detailed description
The proposed study will assess the safety, feasibility, and efficacy of the use of the ER-REBOA™ catheter as a means of increasing cardio-cerebral perfusion in medical cardiac arrest patients. The ER-REBOA™ catheter is a device that has been gaining increased use in the setting of severe trauma for the purposes of stopping intra-abdominal hemorrhage. The catheter is advanced through a femoral artery sheath into the aorta, where a balloon at its tip is inflated, occluding all distal blood flow (and stopping any hemorrhage while the patient can be prepared for definitive operative intervention).
Dr. Daley (along with previous investigators) has hypothesized that by using the device to occlude distal blood flow during medical cardiac arrest, one might increase the perfusion to the brain and heart, maximizing the patient's chance for cardiac and neurologic recovery. Aortic occlusion for medical cardiac arrest is supported by robust pre-clinical literature, but has not yet been studied in humans.
The proposed study is divided into two phases, with a different primary outcome in each phase. Phase 1 of the study is expected to occur over a period of 1 year. Phase 2 expected duration is 1.5 years. Each phase of the study will require separate FDA/IRB approval. Enrollment will take place at Yale-New Haven Hospital in New Haven, CT, the primary site for Phase 1 and Phase 2 of the study. A potential secondary site, the University of California, Davis, has been approved for trial participation but will not contribute to enrollment during Phase 1.
Phase 1 will primarily examine the feasibility and safety of the use of the ER-REBOA catheter in five non-traumatic cardiac arrest patients. If deemed feasible and safe, the PI will request permission from the FDA and the IRB to expand the study to Phase 2. Phase 2 will consist of the enrollment of a subsequent 15 patients (20 in total for both phase 1 and 2) with a primary focus on procedural performance, hemodynamic response to aortic occlusion, and patient-centered outcome variables. Per our hypothesis, if the ER-REBOA catheter is efficacious in medical cardiac arrest patients, an increase in systolic and diastolic blood pressure should be evident after the inflation of the intra-aortic balloon. Phase 2 will utilize the built in continuous arterial blood pressure monitoring capabilities of the device to assess for a significant blood pressure increase after the deployment of the aortic balloon.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- REBOA in medical cardiac arrest patients
| Arm | Type | Receives |
|---|---|---|
| REBOA | Experimental | Device: ER-REBOA catheterPatients undergoing REBOA for medical cardiac arrest |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient must have had a witnessed cardiac arrest2 of suspected medical etiology
- CPR initiation within approximately 6 minutes of collapse (as estimated based on history provided by EMS), either by EMS, hospital personnel, or a bystander
Key exclusion criteria (10 listed)
- Known active terminal illness or severe dementia
- Known aortic disease
- Age 80 or older
- Total resuscitation time greater than approximately 45 minutes (from start of CPR)
- Age less than 18
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 |
|---|---|---|
| ER-REBOA catheterThe ER-REBOA™ catheter is a device that has been gaining increased use in the setting of severe trauma for the purposes of stopping intra-abdominal hemorrhage. The catheter is advanced through a femoral artery sheath into the aorta, where a balloon at its tip is inflated, occluding all distal blood flow (and stopping any hemorrhage while the patient can be prepared for definitive operative intervention). | Device | REBOA |
Primary outcome
Feasibility of aortic occlusion
Time frame: The time expected for the procedure typically take between 10 and 15 minutes.
The successful inflation of the aortic balloon at the level of the diaphragm with resultant occlusion of aortic blood flow. The procedure will be considered feasible if aortic balloons are deployed at the level of the diaphragm in at least 70% of patients attempted. The location of the balloon will be confirmed with bedside ultrasound and/or X-ray. Successful aortic occlusion will be confirmed using flow measurements on bedside ultrasound as well as detecting a lack of blood pressure distal to the aortic balloon using a pressure transducer in the femoral artery.
Safety of Procedure
Time frame: Time of procedure to 90-days post-discharge
Safety is defined by a composite prevalence of five pre-specified adverse events. •Composite events: blood vessel damage requiring intervention, arterial thromboembolism, lower extremity amputation, renal failure requiring non-temporary dialysis, lower extremity paralysis
13 secondary outcomes
Time from first needle stick to sheath insertion
Time frame: Time of micropuncture needle first insertion into common femoral artery until successful 7 French (Fr) sheath insertion into common femoral artery
Time from first needle stick to Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) balloon inflation
Time frame: Time when micropuncture needle first insertion into common femoral artery until REBOA catheter balloon successfully inflated with 8 cc saline
Number of needle sticks required for sheath insertion
Time frame: Time from first micropuncture needle stick until successful insertion of 7 Fr sheath into common femoral artery up to 30 minutes
Change in systolic blood pressure after aortic occlusion
Time frame: 1 minutes before and 15 minutes after aortic occlusion
Change in diastolic blood pressure after aortic occlusion
Time frame: 1 minute before and 15 minutes after aortic occlusion
Change in end tidal carbon dioxide after aortic occlusion
Time frame: 1 minute before and 15 minutes after aortic occlusion
Change in oxygen saturation from pulse oximeter
Time frame: 1 minute before and 15 minutes after aortic occlusion
Change in coronary perfusion pressure
Time frame: 1 minute before and 15 minutes after aortic occlusion
Change in Electrocardiogram (ECG) patterns
Time frame: 1 minute before and 15 minutes after aortic occlusion
Neurologic function at 30 and 90 days
Time frame: 30 and 90 days post enrollment
Rate of return of spontaneous circulation (ROSC)
Time frame: Arrival in ED to sustained ROSC or death, assessed up to 1 hour
Rate of Intensive Care Unit (ICU) Admission
Time frame: Death in ED or admission to ICU post sustained ROSC, assessed up to 24 hours
Length of stay in ICU and total length of hospitalization
Time frame: Time of admission in ICU to discharge or death, assessed up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Background: PubMed 28117180Daley J, Morrison JJ, Sather J, Hile L. The role of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct to ACLS in non-traumatic cardiac arrest. Am J Emerg Med. 2017 May;35(5):731-736. doi: 10.1016/j.ajem.2017.01.010. Epub 2017 Jan 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ER-REBOA catheter in people with Cardiac Arrest, run by Yale University at 1 site 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 2 inclusion and 10 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 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of aortic occlusion (time frame: The time expected for the procedure typically take between 10 and 15 minutes.). The study lists 2 primary outcomes in all. 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 NCT03703453, which also lists 1 linked publication.
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 24 Aug 2021.