High-Risk Percutaneous Coronary InterventionELEVATE INCT06099548
Magenta Elevate™ First-in-Human Clinical Study 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 Georgia.
Trial summary
The Elevate™ First-In-Human (FIH) study is designed to evaluate the initial safety and device functionality of the 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 40 to 83 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
- 20 participants
- Where
- 2 sitesGeorgia
- Study dates
- 17 Dec 2020to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 83 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 ≤ 45% 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)
- Femoral artery diameter compatible with the use of Elevate™
- Subject signed informed consent
Who cannot join
- Subject age < 40 or ≥ 83 years
- Cardiogenic shock
- Left ventricular mural thrombus
- Presence of a mechanical aortic valve or a heart-constrictive device
- Aortic stenosis
- Moderate or severe aortic regurgitation (≥ 2+ by Transthoracic Echocardiography)
Show all 13Show fewer
- Severe peripheral vascular disease
- Aortic pathology, such as aortic aneurysms, extreme tortuosity or calcifications that could pose an undue additional risk to the placement of a pLVAD device
- Chronic renal dysfunction (serum creatinine ≥ 3.5 mg/dL)
- Uncorrectable abnormal coagulation parameters (defined as platelet count ≤ 75,000 or INR ≥ 2.0 or fibrinogen ≤ 1.5 g/L)
- Active systemic infection
- Stroke or transient ischemic attack within 3 months of enrollment
- Female subjects who are pregnant or breast-feeding
Trial locations and contacts
2 sites in 1 country.
Georgia2 sites
Israeli-Georgian Medical Research Clinic "Helsicore"
Tbilisi
Tbilisi Heart and Vascular Clinic
Tbilisi
About this study
Official title: First-in-Human (FIH) Clinical Investigation Protocol of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients Undergoing Non-emergent, High-risk Percutaneous Coronary Interventions (ELEVATE I)
The Elevate™ First-In-Human (FIH) study is designed to evaluate the initial safety and device functionality of the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary interventions.
Read the detailed description
The Elevate™ System FIH study is planned as a prospective, single-arm, interventional study of up to 20 patients.
The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (HR-PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.
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.
- Being tested
- The Elevate™ System
- Keywords
- HR-PCI, High-risk percutaneous coronary intervention, Mechanical Circulatory Support, Left ventricular unloading, HRPCI, Temporary MCS
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 (HR-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.
Device Performance
Rate of procedural hypotension
Measured: Through the end of the procedure
Device Safety
Rate of Major Device-Related Adverse Events
Measured: Through the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start17 Dec 2020
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
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 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Magenta Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099548
- Sponsor's protocol ID
- DRD00385
- Acronym
- ELEVATE I
- Status last verified
- May 2025
- First submitted
- 18 Oct 2023
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schwammenthal E, Gogorishvili I, Sievert H, Fefer P, Pinto DS. High-Output Mechanical Circulatory Support in Left Main Interventions: The Magenta Elevate High-Risk PCI First-in-Human Study. JACC Cardiovasc Interv. 2024 Dec 23;17(24):2851-2862. doi: 10.1016/j.jcin.2024.09.017.
PubMed 39722267
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human (FIH) Clinical Investigation Protocol of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients Undergoing Non-emergent, High-risk Percutaneous Coronary Interventions (ELEVATE I)
- ClinicalTrials.gov ID
- NCT06099548
- Acronym / sponsor ID
- ELEVATE I / DRD00385
- Keywords
- HR-PCI, High-risk percutaneous coronary intervention, Mechanical Circulatory Support, Left ventricular unloading, HRPCI, Temporary MCS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Magenta Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 25 Oct 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™ First-In-Human (FIH) study is designed to evaluate the initial safety and device functionality of the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary interventions.
Detailed description
The Elevate™ System FIH study is planned as a prospective, single-arm, interventional study of up to 20 patients.
The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (HR-PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.
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.
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
- 40 to 83 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 ≤ 45% and at least one of the following:
- Femoral artery diameter compatible with the use of Elevate™
- Subject signed informed consent
Key exclusion criteria (13 listed)
- Subject age < 40 or ≥ 83 years
- Cardiogenic shock
- Left ventricular mural thrombus
- Presence of a mechanical aortic valve or a heart-constrictive device
- Aortic stenosis
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 (HR-PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease. | Device | HR-PCI patients |
Primary outcome
Device Performance
Time frame: Through the end of the procedure
Rate of procedural hypotension
Device Safety
Time frame: Through the end of the procedure
Rate of Major Device-Related Adverse Events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 39722267Schwammenthal E, Gogorishvili I, Sievert H, Fefer P, Pinto DS. High-Output Mechanical Circulatory Support in Left Main Interventions: The Magenta Elevate High-Risk PCI First-in-Human Study. JACC Cardiovasc Interv. 2024 Dec 23;17(24):2851-2862. doi: 10.1016/j.jcin.2024.09.017.
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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.
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 Georgia.
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 13 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: under way, not looking for participants, as of the sponsor's last update on 30 May 2025. 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 Georgia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Device Performance (time frame: Through the end of the procedure). 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 NCT06099548, 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 30 May 2025; AzTrials last refreshed its copy on 1 Nov 2026.