High-risk Percutaneous Coronary InterventionNCT05727059
Magenta Elevate™ EFS in High-Risk PCI Patients
A study testing The Elevate™ System in people with High-risk Percutaneous Coronary Intervention, run by Magenta Medical Ltd. at 2 sites in United States.
Trial summary
The Elevate™ EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary interventions. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- High-risk Percutaneous Coronary Intervention
- What is being tested?
- The Elevate™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2023to 2 Jan 2024
- Phase
- Interventional
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-emergent, percutaneous coronary intervention is planned in at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis).
- Ejection fraction of ≤ 50% and at least one of the following:
- Intervention on an unprotected left main coronary artery
- Intervention on a last patent coronary conduit
- Three-vessel disease (in case of left coronary artery dominance, the combination of a left anterior descending artery (LAD) lesion and a proximal left circumflex artery (LCX) lesion qualifies as three-vessel disease).
- A heart team that includes a cardiac surgeon has determined that high-risk PCI is the appropriate therapeutic option.
- Subject signed informed consent.
Who cannot join
- Subject age < 18 or ≥ 85 years.
- Cardiogenic shock (systolic blood pressure < 90 mmHg with evidence of end organ hypoperfusion, such as cool extremities or urine < 30 mL/hour); acutely decompensated pre-existing chronic heart failure; any use of inotropic or vasopressor in the previous 48 hours; or any use of mechanical circulatory support or an extracorporeal membrane oxygenation device within 14 days.
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis
- Evidence of left ventricular thrombus.
- Previous aortic valve replacement or repair or a heart-constrictive device.
- Aortic stenosis
Show all 22Show fewer
- Aortic regurgitation (≥ 2+ on a 4-grade scale by Transthoracic Echocardiography).
- Aortic pathology, such as aortic aneurysms, dissection, extreme tortuosity, calcifications, or prior aortic surgery, that could pose undue additional risk to the placement of a pLVAD device.
- Left ventricle rupture.
- Cardiac tamponade.
- Subject is scheduled for a staged PCI within 90 days of the index procedure
- Subject has any condition or scheduled surgery that will require discontinuation of the antiplatelet and/or anticoagulant therapy within 90 days of the index procedure.
- Chronic renal dysfunction (eGFR <30 mL/min/1.73 m²) and patients requiring renal replacement therapy with dialysis.
- Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000 or spontaneous INR ≥ 1.5 or known fibrinogen ≤ 1.5 g/L).
- Infection of the proposed procedural access site or suspected systemic active infection, including any fever.
- Active COVID-19 infection.
- Stroke or transient ischemic attack within 6 months of enrollment.
- Subject participation in another investigational drug or device trial (with the exception of post-market registries and observational studies, subject to Sponsor review and approval).
- Female subjects who are pregnant or breast-feeding.
- Any non-cardiac condition with a life expectancy <24 months
- Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to provide written informed consent and/or to comply with study procedures.
- Subject belongs to a vulnerable population defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of providing informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mount Sinai Hospital
New York, New York, 10029
New York-Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Early Feasibility Study (EFS) of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients Undergoing Non-emergent, High-risk Percutaneous Coronary Interventions
The Elevate™ EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary interventions.
Read the detailed description
The Elevate™ EFS is planned as a prospective, single-arm, interventional multi-center study enrolling up to 20 subjects.
The Magenta Elevate™ Pump is a catheter-mounted, self-expanding and retrievable pump, designed to unload the left ventricle by actively transporting blood from the left ventricle into the ascending aorta.
The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.
- Being tested
- The Elevate™ System
- Keywords
- HRPCI, High-risk percutaneous coronary intervention, Circulatory support, Left ventricular unloading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Elevate™ SystemDevice
The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.
| Study group | Role | What they receive |
|---|---|---|
| HR-PCI patients | Experimental | Patients undergoing non-emergent, high-risk percutaneous coronary interventions Receives: Device: The Elevate™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Device-Related Adverse Events (MDRAE)
The rate of Elevate™ related Serious Adverse Events
Measured: From device delivery through device removal (up to 6 hours)
Rate of successful initiation and maintenance of hemodynamic support without Severe Hypotension
Rate of successful initiation and maintenance of Elevate™ hemodynamic support without Severe Hypotension
Measured: From device delivery through device removal (up to 6 hours)
Secondary outcomes (4)
Rate of Elevate™ Technical Success
The rate of complete Elevate™ Pump delivery procedures, including operation of the Pump without Device Malfunction and successful retrieval of the Pump
Measured: From device delivery through device removal (up to 6 hours)
Rate of Elevate™ Procedural Success
The rate of Elevate™ Technical Success without Severe Hypotension
Measured: From device delivery through device removal (up to 6 hours)
Rate of Major Device-Related Adverse Events (MDRAE)
The rate of Elevate™ related Serious Adverse Events
Measured: From device removal through hospital discharge (assessed up to 30 days)
Rate of Major Device-Related Adverse Events (MDRAE)
The rate of Elevate™ related Serious Adverse Events
Measured: From hospital discharge through 30-days post device removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start8 May 2023
- Primary completion1 Dec 2023
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk Percutaneous Coronary InterventionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Magenta Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zohar Bronshtine, Study director, Magenta Medical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727059
- Sponsor's protocol ID
- DRD00417
- Status last verified
- Sep 2024
- First submitted
- 25 Jan 2023
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study (EFS) of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients Undergoing Non-emergent, High-risk Percutaneous Coronary Interventions
- ClinicalTrials.gov ID
- NCT05727059
- Acronym / sponsor ID
- DRD00417
- Keywords
- HRPCI, High-risk percutaneous coronary intervention, Circulatory support, Left ventricular unloading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Magenta Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 May 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 14 Feb 2023 (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 Elevate™ EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary interventions.
Detailed description
The Elevate™ EFS is planned as a prospective, single-arm, interventional multi-center study enrolling up to 20 subjects.
The Magenta Elevate™ Pump is a catheter-mounted, self-expanding and retrievable pump, designed to unload the left ventricle by actively transporting blood from the left ventricle into the ascending aorta.
The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HR-PCI patients | Experimental | Device: The Elevate™ SystemPatients undergoing non-emergent, high-risk percutaneous coronary interventions |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Non-emergent, percutaneous coronary intervention is planned in at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis).
- Ejection fraction of ≤ 50% and at least one of the following:
- A heart team that includes a cardiac surgeon has determined that high-risk PCI is the appropriate therapeutic option.
- Subject signed informed consent.
Key exclusion criteria (22 listed)
- Subject age < 18 or ≥ 85 years.
- Cardiogenic shock (systolic blood pressure < 90 mmHg with evidence of end organ hypoperfusion, such as cool extremities or urine < 30 mL/hour); acutely decompensated pre-existing chronic heart failure; any use of inotropic or vasopressor in the previous 48 hours; or any use of mechanical circulatory support or an extracorporeal membrane oxygenation device within 14 days.
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis
- Evidence of left ventricular thrombus.
- Previous aortic valve replacement or repair or a heart-constrictive device.
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 |
|---|---|---|
| The Elevate™ SystemThe Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease. | Device | HR-PCI patients |
Primary outcome
Rate of Major Device-Related Adverse Events (MDRAE)
Time frame: From device delivery through device removal (up to 6 hours)
The rate of Elevate™ related Serious Adverse Events
Rate of successful initiation and maintenance of hemodynamic support without Severe Hypotension
Time frame: From device delivery through device removal (up to 6 hours)
Rate of successful initiation and maintenance of Elevate™ hemodynamic support without Severe Hypotension
4 secondary outcomes
Rate of Elevate™ Technical Success
Time frame: From device delivery through device removal (up to 6 hours)
Rate of Elevate™ Procedural Success
Time frame: From device delivery through device removal (up to 6 hours)
Rate of Major Device-Related Adverse Events (MDRAE)
Time frame: From device removal through hospital discharge (assessed up to 30 days)
Rate of Major Device-Related Adverse Events (MDRAE)
Time frame: From hospital discharge through 30-days post device removal
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 26 Sep 2024.
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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.
Zohar Bronshtine study director
Magenta Medical Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Elevate™ System in people with High-risk Percutaneous Coronary Intervention, run by Magenta Medical Ltd. at 2 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 7 inclusion and 22 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 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Rate of Major Device-Related Adverse Events (MDRAE) (time frame: From device delivery through device removal (up to 6 hours)). 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?
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 26 Sep 2024.