Resuscitative EndoVascular Aortic Occlusion for Maximal Perfusion (REVAMP)

August 22, 2021 updated by: James I. Daley, Yale University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: REBOA
Patients undergoing REBOA for medical cardiac arrest
Device: ER-REBOA catheter
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
The time expected for the procedure typically take between 10 and 15 minutes.
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
Time of procedure to 90-days post-discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Procedural
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
Procedural
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
Procedural
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
Hemodynamic
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
Hemodynamic
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
Hemodynamics
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
Hemodynamics
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
Hemodynamics
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
Hemodynamics
1 minute before and 15 minutes after aortic occlusion
Neurologic function at 30 and 90 days
Time Frame: 30 and 90 days post enrollment

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
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
Patient Oriented
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
Patient Oriented
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
Patient Oriented
Time of admission in ICU to discharge or death, assessed up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000023899

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Arrest

Clinical Trials on ER-REBOA catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings