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Pivotal Randomized Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)

NCT ID: NCT07296744

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

358 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-07-31

Brief Summary

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The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. Eligible patients will be randomized to undergo HRPCI with either the Supira System (investigational device) or the commercially available Impella systems (comparator device).

Detailed Description

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The Supira System is a minimally invasive percutaneous ventricular assist device (pVAD) that is intended to provide temporary hemodynamic support (≤ 4 hours) to patients undergoing HRPCI. The Supira Catheter is inserted percutaneously through the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance, with the pump outlet remaining in the ascending aorta. The pump portion of the Catheter compresses during insertion in the Introducer Sheath and re-expands during use. It actively unloads the left ventricle by pumping blood from the ventricle into the ascending aorta and systemic circulation.

Conditions

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Coronary Artery Disease High Risk Percutaneous Coronary Intervention Interventional Cardiology Mechanical Circulatory Support

Keywords

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Percutaneous ventricular assist device Supira System Mechanical Circulatory Support US Pivotal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective, multicenter, open label, randomized controlled trial (RCT). Subjects undergoing HRPCI will be randomized (1:1)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supira System

Subjects receiving the Supira System

Group Type EXPERIMENTAL

The Supira System

Intervention Type DEVICE

The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent HRPCI performed in hemodynamically stable patients with severe coronary artery disease when a heart team has determined HRPCI is the appropriate therapeutic option.

Impella

Subjects receiving the Impella

Group Type ACTIVE_COMPARATOR

Impella

Intervention Type DEVICE

The current commercially available Impella CP with SmartAssist Catheter is indicated for providing temporary (≤ 6 hours) ventricular support during elective or urgent high risk percutaneous coronary i

Interventions

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The Supira System

The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent HRPCI performed in hemodynamically stable patients with severe coronary artery disease when a heart team has determined HRPCI is the appropriate therapeutic option.

Intervention Type DEVICE

Impella

The current commercially available Impella CP with SmartAssist Catheter is indicated for providing temporary (≤ 6 hours) ventricular support during elective or urgent high risk percutaneous coronary i

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 subject 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
* Left ventricular thrombus
* Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device or the comparator device
* Ongoing renal replacement therapy with dialysis
* Presence of decompensated liver disease; severe liver dysfunction
* Infection of the proposed procedural access site or active infection
* 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
* Any condition, coagulopathy, planned procedure or contraindication that requires discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the 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
* 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 per the investigator's assessment
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Supira Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Supira Medical

Role: CONTACT

Email: [email protected]

Other Identifiers

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CP-10004

Identifier Type: -

Identifier Source: org_study_id