Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study

NCT04674111 | Completed Results

• 1 other identifier: S2465
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 2

Brief Summary

Vortex - First in Human study to evaluate the feasibility, safety, clinical and technical success of the Vortex temporary percutaneous, transvalvular circulatory support system (Vortex System)

Conditions

Coronary Artery Disease

Keywords

Mechanical circulatory support; High risk percutaneous coronary intervention (HR PCI)

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Technical Success

  Successful delivery of the device to the correct anatomical position and successful operation and removal of the Vortex circulatory support system during high-risk PCI procedure.

  Technical success is measured during the procedure. Procedure time varies by patient and is measured from 1st vascular puncture for sheath insertion to vascular closure post sheath removal. Mean procedure time was 116.0 minutes (70.0 min, 148.0 max).

• Number of Participants With Clinical Success

  No conversion to open heart surgery during the high-risk PCI procedure and no in-hospital mortality.

  Clinical success is measured during the procedure. Procedure time varies by patient and is measured from 1st vascular puncture for sheath insertion to vascular closure post sheath removal. Mean procedure time was 116.0 minutes (70.0 min, 148.0 max).

Study Arms (1)

Vortex Feasibility Study (Vortex FIH)

EXPERIMENTAL

Vortex - First in Human Study to Evaluate the Feasibility, Safety, Clinical and Technical Success of the Vortex Temporary Percutaneous, Transvalvular Circulatory Support System (Vortex System)

Device: Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)

Interventions

Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System) DEVICE

The Vortex System is intended to provide temporary circulatory support in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).

Vortex Feasibility Study (Vortex FIH)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• IC1. Subject provides signed informed consent. IC2. Subject is ≥ 18 years and \< 90 years of age.
• IC3 Subject is indicated for NON-emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or coronary artery bypass graft (CABG) and has left ventricular ejection fraction (LVEF) ≤ 50% with the following:
• Unprotected left main -OR-
• Last remaining vessel -OR-
• Three vessel disease (≥ 50% diameter stenoses by visual estimate or total occlusion)
• EC1. Subject has had ST-elevation myocardial infarction (STEMI) within 24 hours.
• EC2. Subject has had pre-procedure cardiac arrest requiring cardiopulmonary resuscitation (CPR) within 24 hours of enrollment.
• EC3. Subject is in shock, defined as follows:
• Cardiac index (CI) \< 2.2 L/min/m2 and pulmonary capillary wedge pressure (PCWP) \> 15 mmHg -AND-
• Hypotension (systolic blood pressure \< 90 mmHg for \> 30 minutes) -OR-
• Need for supportive measures (i.e., inotropes or mechanical support) to maintain systolic blood pressure ≥ 90 mmHg and end organ hypoperfusion (cool extremities or urine \< 30 mL/hour and a heart rate \> 60 beats per minute) EC4. Subject has left ventricular mural thrombus. EC5. Subject has a prosthetic aortic valve. EC6. Subject has pericarditis or constrictive heart disease (constrictive pericarditis or restrictive cardiomyopathy).
• EC7. Subject has moderate or greater aortic valve stenosis or moderate or greater aortic valve insufficiency (by echocardiographic assessment, graded as ≥ 2+).
• EC8. Subject has abnormalities of the aorta that preclude safe delivery of the device, including severe calcification, tortuosity, aneurysm, or prior surgery.
• EC9. Subject has peripheral vessel disease (PVD) preventing passage of the device (e.g., calcification, small caliber) or tortuosity that would preclude safe placement of the 16 Fr introducer sheath.
• Note: Minimum required vessel diameter is \> 5.5 mm. EC10. Subject has advanced renal dysfunction (AKIN Stage 3). EC11. Subject has a history of liver dysfunction (Childs Class C) with elevation of liver enzymes and bilirubin \> 3× upper limit of normal (ULN) or international normalization ratio (INR) ≥ 2.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Skane University Hospital

Lund, 222-42, Sweden

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Amy Maurer, Director of Clinical Trials
• Organization: Boston Scientific Corporation

amy.maurer@bsci.com

800-876-9960

Study Officials

• Prof. Antony Walton, MBBS

  The Alfred

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open-label, single-arm feasibility study

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: September 28, 2021
• Primary Completion: April 8, 2022
• Study Completion: April 8, 2022
• Last Updated: April 24, 2024
• Results First Posted: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); SE (1)