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New treatment option for Heart Disease
Official title Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure
ClinicalTrials.gov ID: NCT07407816
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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...
- Subject may benefit from hemodynamic support beyond the index procedure
- Informed consent granted by the patient or legally authorized representative
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tbilisi, K'alak'i T'bilisi, Georgia
- Tbilisi, Georgia
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tbilisi, K'alak'i T'bilisi, Georgia; Tbilisi, Georgia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.