Heart DiseaseNCT07407816
Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure
A study testing Supira System in people with Heart Disease and Coronary Arterial Disease (CAD), run by Supira Medical at 2 sites in Georgia.
Trial summary
The objective of this study is to assess the safety and feasibility of the Supira System in heart failure patients with low LVEF, undergoing HRPCI with use of mechanical circulatory support who may benefit from cardiovascular hemodynamic support beyond the PCI procedure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Disease, Coronary Arterial Disease (CAD), Heart Failure
- 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
- 45 participants
- Where
- 2 sitesGeorgia
- Study dates
- 12 Oct 2025to May 2027
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has pre-existing heart failure, with NYHA Class II, III or IV prior to the index admission and documented LVEF ≤ 45%
- Subject is presenting with one of the following criteria: unprotected left main coronary artery (ULMCA) disease, last patent vessel, or 3-vessel disease
- Subject may benefit from hemodynamic support beyond the index procedure
- Informed consent granted by the patient or legally authorized representative
Who cannot join
- Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
- Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE)
- Aortic stenosis and/or aortic regurgitation categorized as moderate or greater (mean gradient >20 mmHg or valve area <1.5 cm2 as assessed on TTE)
- Presence of decompensated liver disease; severe liver dysfunction (Child-Pugh Score class C)
- Ongoing renal replacement therapy with dialysis or continues renal replacement therapy
- Heparin-induced thrombocytopenia, current or any prior occurrences
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- 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 in the absence of medication or known fibrinogen ≤1.5 g/L)
- Breastfeeding or pregnant
- Currently participating in active follow-up phase of another clinical study of an investigational drug or device
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical contact
Georgia2 sites, 2 recruiting
- Recruiting
Tbilisi Heart and Vascular Clinic
Tbilisi, K'alak'i T'bilisi, 0112
Elene Khabeishvili, MD, +995 32 218 15 55, Elenekhabeishvili@outlook.com
- Recruiting
Israeli-Georgian Medical Research Clinic HealthyCore 13g Tevdore-Mghvdeli Street Tbilisi Georgia
Tbilisi
Eter Bekaia, + 995 32 243 33 43, annabekaia@gmail.com
About this study
Official title: Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) Who May Benefit From Mechanical Circulatory Support Beyond the PCI Procedure
The objective of this study is to assess the safety and feasibility of the Supira System in heart failure patients with low LVEF, undergoing HRPCI with use of mechanical circulatory support who may benefit from cardiovascular hemodynamic support beyond the PCI procedure.
Read the detailed description
The study is a prospective, non-randomized, single-arm, multi-center, feasibility study.
The Supira System is a minimally invasive, percutaneous ventricular assist device (pVAD) that is intended to provide hemodynamic support to patients undergoing high risk percutaneous coronary intervention (HRPCI) and requiring hemodynamic support. The Catheter is inserted percutaneously, across the aortic valve, and into the left ventricle under fluoroscopic guidance. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation.
- Being tested
- Supira System
- Keywords
- Percutanous ventricular assist device, Supira System
- Medical subject headings
- Heart Diseases, Heart Failure
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, percutaneous ventricular assist device (pVAD) that is intended to provide hemodynamic support to patients undergoing 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. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation.
| Study group | Role | What they receive |
|---|---|---|
| HRPCI with low LVEF and severe CAD | Experimental | Patients undergoing HRPCI with low LVEF and severe coronary artery disease who may benefit from cardiovascular hemodynamic support beyond the PCI procedure Receives: Device: Supira System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Rate of major device-related adverse events (MDRAEs), from device (Supira Introducer sheath) insertion through device removal (inclusive of Supira procedure-related serious adverse events [SAEs]).
Measured: Perioperative/Periprocedural
Feasibility:
Successful hemodynamic support using the Supira System during high-risk percutaneous coronary intervention (HRPCI) and post-PCI as needed, with planned removal of the Supira Pump without the need to escalate/exchange to another MCS device such as Intra-aortic Balloon Pump (IABP) or Extracorporeal Membrane Oxygenation (ECMO).
Measured: Perioperative/Periprocedural
Secondary outcomes (1)
Secondary Study Endpoints
- Rate of technical success
- Rate of procedural success
- Rate of composite MDRAEs from cath lab discharge to Supira Catheter removal
- Rate of composite MDRAEs from Supira Catheter removal to hospital discharge
- Rate of MDRAEs from hospital discharge to 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start12 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility Study
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Supira Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical, Study director, Supira Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407816
- Sponsor's protocol ID
- CP-10005
- Status last verified
- Feb 2026
- First submitted
- 31 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) Who May Benefit From Mechanical Circulatory Support Beyond the PCI Procedure
- ClinicalTrials.gov ID
- NCT07407816
- Acronym / sponsor ID
- CP-10005
- Keywords
- Percutanous ventricular assist device, Supira System
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Supira MedicalIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 12 Feb 2026 (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 assess the safety and feasibility of the Supira System in heart failure patients with low LVEF, undergoing HRPCI with use of mechanical circulatory support who may benefit from cardiovascular hemodynamic support beyond the PCI procedure.
Detailed description
The study is a prospective, non-randomized, single-arm, multi-center, feasibility study.
The Supira System is a minimally invasive, percutaneous ventricular assist device (pVAD) that is intended to provide hemodynamic support to patients undergoing high risk percutaneous coronary intervention (HRPCI) and requiring hemodynamic support. The Catheter is inserted percutaneously, across the aortic valve, and into the left ventricle under fluoroscopic guidance. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility Study
| Arm | Type | Receives |
|---|---|---|
| HRPCI with low LVEF and severe CAD | Experimental | Device: Supira SystemPatients undergoing HRPCI with low LVEF and severe coronary artery disease who may benefit from cardiovascular hemodynamic support beyond the PCI procedure |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has pre-existing heart failure, with NYHA Class II, III or IV prior to the index admission and documented LVEF ≤ 45%
- Subject is presenting with one of the following criteria: unprotected left main coronary artery (ULMCA) disease, last patent vessel, or 3-vessel disease
- Subject may benefit from hemodynamic support beyond the index procedure
- Informed consent granted by the patient or legally authorized representative
Key exclusion criteria (11 listed)
- Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
- Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE)
- Aortic stenosis and/or aortic regurgitation categorized as moderate or greater (mean gradient >20 mmHg or valve area <1.5 cm2 as assessed on TTE)
- Presence of decompensated liver disease; severe liver dysfunction (Child-Pugh Score class C)
- Ongoing renal replacement therapy with dialysis or continues renal replacement therapy
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, percutaneous ventricular assist device (pVAD) that is intended to provide hemodynamic support to patients undergoing 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. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation. | Device | HRPCI with low LVEF and severe CAD |
Primary outcome
Safety
Time frame: Perioperative/Periprocedural
Rate of major device-related adverse events (MDRAEs), from device (Supira Introducer sheath) insertion through device removal (inclusive of Supira procedure-related serious adverse events [SAEs]).
Feasibility:
Time frame: Perioperative/Periprocedural
Successful hemodynamic support using the Supira System during high-risk percutaneous coronary intervention (HRPCI) and post-PCI as needed, with planned removal of the Supira Pump without the need to escalate/exchange to another MCS device such as Intra-aortic Balloon Pump (IABP) or Extracorporeal Membrane Oxygenation (ECMO).
1 secondary outcome
Secondary Study Endpoints
Time frame: 30 days
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 17 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Clinical contact
Clinical study director
Supira Medical
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supira System in people with Heart Disease and Coronary Arterial Disease (CAD), run by Supira Medical 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. 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?
Contact Clinical (clinical@supiramedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Perioperative/Periprocedural). 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 17 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.