- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06087575
Early Feasibility Study of the Supira System in Patients Undergoing HRPCI (SUPPORT1)
Early Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) - The SUPPORT I Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥18 and ≤90 years
- Presents with hemodynamic stability and need for elective or urgent (not emergent) HRPCI, where hemodynamic support is needed, as determined by the institutional heart team
- Informed consent granted by the patient or legally authorized representative
Exclusion Criteria:
- Cardiogenic shock or acutely decompensated pre-existing chronic heart failure
- Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
- Evidence of left ventricular thrombus as assessed by TTE
- Aortic valvular disease or regurgitation categorized as moderate or greater (≥ 2+ on a 4-grade scale as assessed on TTE)
- Aortic stenosis categorized as moderate or greater (gradient >20 mmHg or valve area <1.5 cm2 as assessed on TTE)
- Previous aortic valve replacement or reconstruction
- 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 systemic active infection requiring ongoing antibiotic therapy
- Heparin-induced thrombocytopenia (HIT), 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 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 post index procedure
- Breastfeeding or pregnant
- Currently participating in active follow-up phase of another clinical study of an investigational drug or device
- Active COVID-related infection or prior COVID-19 diagnosis with sequelae that could confound endpoint assessments
- 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
- Considered to be part of a vulnerable population
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supira System
Ventricular support indicated for use during elective or urgent high-risk percutaneous coronary interventions.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility - Successful initiation and maintenance of hemodynamic support
Time Frame: From device delivery through device removal (up to 4 hours)
|
Successful initiation and maintenance of hemodynamic support without severe hypotension throughout the index procedure.
Severe hypotension is defined as sustained mean arterial pressure (MAP) < 55 mmHg requiring inotropic/pressor medications and/or alternative mechanical circulatory support.
|
From device delivery through device removal (up to 4 hours)
|
Safety - Rate of composite major device-related adverse events (MDRAE)
Time Frame: From device delivery through device removal (up to 4 hours)
|
Rate of composite major device-related adverse events (MDRAE), device delivery through device removal.
MDRAEs are defined as any events that are adjudicated by the CEC as definitely, possibly, or probably related to the Supira System.
|
From device delivery through device removal (up to 4 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical Success
Time Frame: From device delivery through device removal (up to 4 hours)
|
Rate of technical success, defined as completion of the entire Supira System procedure, including delivery, operation without device malfunction, and successful removal of the Catheter
|
From device delivery through device removal (up to 4 hours)
|
Procedural Success
Time Frame: From device delivery through device removal (up to 4 hours)
|
Rate of procedural success, defined as the rate of technical success without procedural serious adverse events (SAEs)
|
From device delivery through device removal (up to 4 hours)
|
Composite major MDRAE
Time Frame: From discharge through 30 days post device removal
|
Rate of composite major device-related adverse events (MDRAE) from device removal through hospital discharge
|
From discharge through 30 days post device removal
|
Composite MDRAE
Time Frame: From discharge through 30 days post device removal
|
Rate of composite MDRAE from hospital discharge through 30 days post device removal
|
From discharge through 30 days post device removal
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CP-10003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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