Clinical trial NCT06565039: A Safety and Effectiveness Study of the Supira System in Patients Undergoing HRPCI - CE 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventricular Assist Device
Lead sponsor: Supira Medical
Sponsor class: INDUSTRY
First posted: 2024-08-21
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is a prospective, non-randomized, single-arm, multicenter study
Primary purpose: TREATMENT

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years and ≤90 years
2. Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary as determined by the institutional Heart Team.
3. Informed consent granted by the patient or legally authorized representative

Exclusion Criteria:

1. 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.
2. Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
3. Evidence of left ventricular thrombus as assessed by Transthoracic Echocardiogram (TTE)
4. Aortic valvular disease or regurgitation categorized as moderate or greater (≥ 2+ on a 4-grade scale as assessed on TTE)
5. Aortic valve stenosis categorized as moderate or greater (gradient \>20 mmHg or valve area \<1.5 cm2 as assessed on TTE)
6. Previous aortic valve replacement or repair
7. Ascending or descending aortic dissection or aortic aneurysm \>4.5 cm
8. Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device
9. Presence of decompensated liver disease; severe liver dysfunction (Child class C)
10. Ongoing renal replacement therapy with dialysis
11. Infection of the proposed procedural access site or active systemic infection requiring ongoing antibiotic therapy
12. Heparin-induced thrombocytopenia, current or any prior occurrences
13. 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
14. 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)
15. Any condition or scheduled surgery that will require discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure
16. Planned coronary intervention within 30 days prior or post index procedure
17. Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure
18. 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
19. Active COVID-related infection or prior COVID-19 diagnosis with sequelae that could confound endpoint assessments
20. 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

Primary outcomes:
measure: Successful initiation and maintenance of hemodynamic support
timeFrame: 90 days from procedure
Secondary outcomes:
measure: Procedural Success
timeFrame: 90 days from procedure
Other outcomes:
Locations:
Study officials:
References: