Ventricular Assist DeviceSUPPORT CENCT06565039
A Safety and Effectiveness Study of the Supira System in Patients Undergoing HRPCI - CE Study
A study testing Supira System in people with Ventricular Assist Device, run by Supira Medical.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of utilizing the Supira System to provide hemodynamic support during HRPCI. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ventricular Assist Device
- What is being tested?
- Supira System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Sep 2026
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤90 years
- Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary as determined by the institutional Heart Team.
- Informed consent granted by the patient or legally authorized representative
Who cannot join
- Cardiogenic shock or acutely decompensated pre-existing chronic heart failure a. Note: Cardiogenic shock is defined as: systemic hypotension (systolic blood pressure [BP] <90 mmHg or the need for inotropes/pressors to maintain a systolic BP >90 mmHg) plus one of the following: any requirement for inotropes/pressors prior to arrival at the catheterization laboratory, clinical evidence of end-organ hypoperfusion or use of IABP or any other circulatory support device at time of screening.
- Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
- Evidence of left ventricular thrombus as assessed by Transthoracic Echocardiogram (TTE)
- Aortic valvular disease or regurgitation categorized as moderate or greater (≥ 2+ on a 4-grade scale as assessed on TTE)
- Aortic valve stenosis categorized as moderate or greater (gradient >20 mmHg or valve area <1.5 cm2 as assessed on TTE)
- Previous aortic valve replacement or repair
Show all 20Show fewer
- Ascending or descending aortic dissection or aortic aneurysm >4.5 cm
- Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device
- Presence of decompensated liver disease; severe liver dysfunction (Child class C)
- Ongoing renal replacement therapy with dialysis
- Infection of the proposed procedural access site or active systemic infection requiring ongoing antibiotic therapy
- Heparin-induced thrombocytopenia, current or any prior occurrences
- Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or known hypersensitivity to heparin, aspirin, adenosine diphosphate (ADP) receptor inhibitors, or nitinol
- Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000/mm³ or spontaneous International Normalized Ratio (INR) ≥ 1.5 or known fibrinogen ≤ 1.5 g/L)
- Any condition or scheduled surgery that will require discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure
- Planned coronary intervention within 30 days prior or post index procedure
- Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure
- Currently participating in active follow-up phase of another clinical study of an investigational drug or device or planning to enroll in such a study within 90 days of the HRPCI procedure
- Active COVID-related infection or prior COVID-19 diagnosis with sequelae that could confound endpoint assessments
- Other medical, social, or psychological problems that would have them be considered in any way to be part of a vulnerable population. This includes individuals who may have difficulty providing informed consent or are at a higher risk of coercion or undue influence, individuals permanently incapable of giving informed consent, and individuals whose ability to comply with study procedures may be compromised, in the opinion of the Investigator
About this study
Official title: The SUPPORT CE Study: A Safety and Effectiveness Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
The objective of this study is to evaluate the safety and effectiveness of utilizing the Supira System to provide hemodynamic support during HRPCI.
Read the detailed description
The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent high-risk percutaneous coronary interventions (HRPCI) performed in hemodynamically stable patients with severe coronary artery disease when a heart team, including a cardiac surgeon, has determined HRPCI is the appropriate therapeutic option.
Use of the Supira System in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and postprocedural adverse events
- Conditions
- Ventricular Assist Device
- Being tested
- Supira System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supira SystemDevice
The Supira System is a minimally invasive, miniaturized percutaneous ventricular assist (pVAD) system that is intended to provide temporary (≤4 hours) hemodynamic support to patients undergoing a high-risk percutaneous coronary intervention (HRPCI). The Catheter is inserted percutaneously via the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance, with a portion remaining in the ascending aorta. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation.
| Study group | Role | What they receive |
|---|---|---|
| Supira System | Experimental | Ventricular support indicated for use during elective or urgent high-risk percutaneous coronary interventions. Receives: Device: Supira System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful initiation and maintenance of hemodynamic support
A composite endpoint of safety and effectiveness outcomes, evaluated at 90 days, comprises the following outcomes:
- All-cause death
- Myocardial infarction (MI)
- Stroke or transient ischemic attack (TIA)
- Unplanned repeat revascularization
- Major bleeding (BARC ³ 3)
- Major vascular complications (MCS-ARC defined)
- Sustained hypotension during mechanical circulatory support
Measured: 90 days from procedure
Secondary outcomes (1)
Procedural Success
Freedom from:
- Major bleeding (BARC ³ 3)
- Major vascular complications (MCS-ARC defined)
- Sustained hypotension during mechanical circulatory support
- Need for mechanical circulatory support beyond the index procedure
Measured: 90 days from procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study startJan 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Why it stopped: Study was never submitted to any Ethics Committee, Competant Authorities or any regulatory body. It was decided to cancel the study and not to proceed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Assist DeviceStudies 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
- Model description
- The study is a prospective, non-randomized, single-arm, multicenter study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supira Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565039
- Sponsor's protocol ID
- CP-10006
- Acronym
- SUPPORT CE
- Status last verified
- Feb 2026
- First submitted
- 19 Aug 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SUPPORT CE Study: A Safety and Effectiveness Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
- ClinicalTrials.gov ID
- NCT06565039
- Acronym / sponsor ID
- SUPPORT CE / CP-10006
- Conditions
- Ventricular Assist Device
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never submitted to any Ethics Committee, Competant Authorities or any regulatory body. It was decided to cancel the study and not to proceed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Supira MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 21 Aug 2024 (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 evaluate the safety and effectiveness of utilizing the Supira System to provide hemodynamic support during HRPCI.
Detailed description
The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent high-risk percutaneous coronary interventions (HRPCI) performed in hemodynamically stable patients with severe coronary artery disease when a heart team, including a cardiac surgeon, has determined HRPCI is the appropriate therapeutic option.
Use of the Supira System in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and postprocedural adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a prospective, non-randomized, single-arm, multicenter study
| Arm | Type | Receives |
|---|---|---|
| Supira System | Experimental | Device: Supira SystemVentricular support indicated for use during elective or urgent high-risk percutaneous coronary interventions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years and ≤90 years
- Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary as determined by the institutional Heart Team.
- Informed consent granted by the patient or legally authorized representative
Key exclusion criteria (20 listed)
- Cardiogenic shock or acutely decompensated pre-existing chronic heart failure a. Note: Cardiogenic shock is defined as: systemic hypotension (systolic blood pressure [BP] <90 mmHg or the need for inotropes/pressors to maintain a systolic BP >90 mmHg) plus one of the following: any requirement for inotropes/pressors prior to arrival at the catheterization laboratory, clinical evidence of end-organ hypoperfusion or use of IABP or any other circulatory support device at time of screening.
- Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
- Evidence of left ventricular thrombus as assessed by Transthoracic Echocardiogram (TTE)
- Aortic valvular disease or regurgitation categorized as moderate or greater (≥ 2+ on a 4-grade scale as assessed on TTE)
- Aortic valve stenosis categorized as moderate or greater (gradient >20 mmHg or valve area <1.5 cm2 as assessed on TTE)
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 |
|---|---|---|
| Supira SystemThe Supira System is a minimally invasive, miniaturized percutaneous ventricular assist (pVAD) system that is intended to provide temporary (≤4 hours) hemodynamic support to patients undergoing a high-risk percutaneous coronary intervention (HRPCI). The Catheter is inserted percutaneously via the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance, with a portion remaining in the ascending aorta. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation. | Device | Supira System |
Primary outcome
Successful initiation and maintenance of hemodynamic support
Time frame: 90 days from procedure
A composite endpoint of safety and effectiveness outcomes, evaluated at 90 days, comprises the following outcomes: * All-cause death * Myocardial infarction (MI) * Stroke or transient ischemic attack (TIA) * Unplanned repeat revascularization * Major bleeding (BARC ³ 3) * Major vascular complications (MCS-ARC defined) * Sustained hypotension during mechanical circulatory support
1 secondary outcome
Procedural Success
Time frame: 90 days from procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Ventricular Assist Device
Active, not recruiting
Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
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dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation
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Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
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RecruitingPhase 3
SWITCH: Apixaban vs Vitamin K in HM3
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Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
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.
Questions about this trial
What is this clinical trial studying?
A study testing Supira System in people with Ventricular Assist Device, run by Supira Medical.
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 20 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: withdrawn, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Successful initiation and maintenance of hemodynamic support (time frame: 90 days from procedure). 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 12 Feb 2026.