Coronary Artery DiseaseSAFE-MCSNCT05077657
Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System
An observational study of Coronary Artery Disease, run by Saranas, Inc. at 11 sites in United States.
Trial summary
The objective of this study is to establish the safety of complex high-risk Percutaneous Coronary Intervention (PCI) using Mechanical Circulatory Support (MCS) and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Early Bird® Bleed Monitoring System and Impella®
- Type of treatment
- Medical device
- How many people
- 203 participants
- Where
- 11 sitesUnited States
- Study dates
- 29 Nov 2021to 19 Dec 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing complex high-risk percutaneous coronary intervention (PCI) with mechanical circulatory support (MCS) via Impella® and transfemoral arterial approach will be enrolled. The Saranas Early Bird Bleed Monitoring System will be used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.
Who may be able to join
- ≥18 years of age
- Planned complex high-risk PCI using MCS with Impella from a femoral access and use of Saranas Early Bird Bleed Monitoring System
- The study patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the institutional review board of the respective clinical site.
Who cannot join
- Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
- Active bleeding
- Incapacity to access safely femoral artery or femoral vein
- Significant femoral, iliac, abdominal, or thoracic aortic disease which precludes placement of MCS
- Anemia (Hgb <9 g/dL), thrombocytopenia (Plt <50,000 cell/mL), history of bleeding diathesis or coagulopathy, or hypercoagulable states
- Active infection not controlled with antibiotic therapy
Show all 9Show fewer
- Currently pregnant or women of child-bearing potential without documented negative pregnancy test
- Estimated life expectancy < 24 hours
- Patient is in cardiogenic shock at the time of enrollment
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Ascension - St. John
Dearborn, Michigan, 48124
Henry Ford Health System
Detroit, Michigan, 48202
Hackensack Meridian Health
Edison, New Jersey, 08837
Methodist Hospitals
Gary, Indiana, 46402
Memorial Hermann / UTH
Houston, Texas, 77030
St. Luke's / Texas Heart
Houston, Texas, 77030
Memorial Hermann NE / TCR Institute
Kingwood, Texas, 77021
Morristown Medical Center
Morristown, New Jersey, 07960
Northwell / Lenox Hill & Staten Island
New Hyde Park, New York, 11042
St. Joseph Hospital / Arizona Heart
Phoenix, Arizona, 85013
Tucson Medical Center / PIMA Heart
Tucson, Arizona, 85719
About this study
The objective of this study is to establish the safety of complex high-risk Percutaneous Coronary Intervention (PCI) using Mechanical Circulatory Support (MCS) and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS).
Read the detailed description
To demonstrate that patients undergoing complex high-risk PCI using MCS and surveillance with the Saranas Early Bird Bleed Monitoring System will have relative incidence rate reduction of access site related BARC type III or V bleeding. An optimal outcome will show a a reduction in access-site related bleeding rate when using MCS with the Saranas EBBMS in high-risk PCI patients compared to historical incidence rate.
- Conditions
- Coronary Artery Disease
- Being tested
- Early Bird® Bleed Monitoring System, Impella®
- Keywords
- Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Bird® Bleed Monitoring SystemDevice
The Early Bird Bleed Monitoring System is used in endovascular procedures to monitor and detect internal bleeding complications in real-time.
Impella®Device
Impella is an FDA-approved percutaneous heart pump indicated for patients with severe coronary artery disease requiring high-risk PCI.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm | This is a multi-center, single arm, open-label study to evaluate the safety of complex high-risk PCI using Impella and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS). Receives: Device: Early Bird® Bleed Monitoring System; Device: Impella® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of access site related BARC type III or V bleeding
Measured: Within 24 hours
Secondary outcomes (2)
Incidence of activation of each Saranas Early Bird level 1, 2 and 3 indicator
Measured: Within 24 hours
Incidence of all BARC type III or V bleeding
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start29 Nov 2021
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saranas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Proxima CRO, Cardiovascular Research Foundation, New York
- Responsible party
- Sponsor
- Investigators
- Mir Basir, DO, Principal investigator, Henry Ford HospitalPhilippe Généreux, MD, Principal investigator, Gagnon Cardiovascular Institute - Morristown Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077657
- Sponsor's protocol ID
- PVP012
- Acronym
- SAFE-MCS
- Status last verified
- Feb 2024
- First submitted
- 1 Oct 2021
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System
- ClinicalTrials.gov ID
- NCT05077657
- Acronym / sponsor ID
- SAFE-MCS / PVP012
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Saranas, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Proxima CRO, Cardiovascular Research Foundation, New York
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 14 Oct 2021 (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.
The objective of this study is to establish the safety of complex high-risk Percutaneous Coronary Intervention (PCI) using Mechanical Circulatory Support (MCS) and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS).
Detailed description
To demonstrate that patients undergoing complex high-risk PCI using MCS and surveillance with the Saranas Early Bird Bleed Monitoring System will have relative incidence rate reduction of access site related BARC type III or V bleeding. An optimal outcome will show a a reduction in access-site related bleeding rate when using MCS with the Saranas EBBMS in high-risk PCI patients compared to historical incidence rate.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm | – | Device: Early Bird® Bleed Monitoring System, Device: Impella®This is a multi-center, single arm, open-label study to evaluate the safety of complex high-risk PCI using Impella and surveillance with the 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
- Study population
- Patients undergoing complex high-risk percutaneous coronary intervention (PCI) with mechanical circulatory support (MCS) via Impella® and transfemoral arterial approach will be enrolled. The Saranas Early Bird Bleed Monitoring System will be used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.
Key inclusion criteria (3 listed)
- ≥18 years of age
- Planned complex high-risk PCI using MCS with Impella from a femoral access and use of Saranas Early Bird Bleed Monitoring System
- The study patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the institutional review board of the respective clinical site.
Key exclusion criteria (9 listed)
- Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
- Active bleeding
- Incapacity to access safely femoral artery or femoral vein
- Significant femoral, iliac, abdominal, or thoracic aortic disease which precludes placement of MCS
- Anemia (Hgb <9 g/dL), thrombocytopenia (Plt <50,000 cell/mL), history of bleeding diathesis or coagulopathy, or hypercoagulable states
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 |
|---|---|---|
| Early Bird® Bleed Monitoring SystemThe Early Bird Bleed Monitoring System is used in endovascular procedures to monitor and detect internal bleeding complications in real-time. | Device | Single-Arm |
| Impella®Impella is an FDA-approved percutaneous heart pump indicated for patients with severe coronary artery disease requiring high-risk PCI. | Device | Single-Arm |
Primary outcome
Incidence of access site related BARC type III or V bleeding
Time frame: Within 24 hours
2 secondary outcomes
Incidence of activation of each Saranas Early Bird level 1, 2 and 3 indicator
Time frame: Within 24 hours
Incidence of all BARC type III or V bleeding
Time frame: Within 24 hours
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 16 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Mir Basir, DO principal investigator
Henry Ford Hospital
Philippe Généreux, MD principal investigator
Gagnon Cardiovascular Institute - Morristown Medical Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Saranas, Inc. at 11 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 9 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 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
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?
Incidence of access site related BARC type III or V bleeding (time frame: Within 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2024.