Controlled Arterial Protection to Ultimately Remove Embolic Material

NCT06103591 | Completed Results FDA Device

• 1 other identifier: EMS-CL-5000
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to demonstrate device feasibility, safety and investigate performance of the EmStop Embolic Protection System when used as indicated in 15 subjects at 2 investigational sites in the U.S.

Conditions

Aortic Valve Stenosis

Keywords

Transcatheter Aortic Valve Replacement; Aortic Valve Replacement

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Procedural Success

  Defined as successful insertion, deployment, positioning, and removal of the EmStop System in the absence of device interference

  During the procedure

• Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days

  Defined as composite of the VARC-2 defined components (all-cause mortality, all stroke (disabling and non-disabling), acute kidney injury stage 2 or 3 (including renal replacement therapy) within 72 hours)

  30 days follow-up

Secondary Outcomes (4)

• Average Number of Captured Embolic Debris

  During the procedure

• Average Number of Captured Particles ≥140 μm in Diameter

  Procedural

• Total Acute Infarct Burden

  14 days pre-procedure to 18-36 hours post-procedure

• Occurrence of Transient Ischemic Attack (TIA)

  30 days

Study Arms (1)

EmStop Embolic Protection System

EXPERIMENTAL

Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System).

Device: The EmStop Embolic Protection System (EmStop System)

Interventions

The EmStop Embolic Protection System (EmStop System) DEVICE

The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures.

EmStop Embolic Protection System

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 21 and 90 years of age at the time of consent
• Meets FDA approved indications for transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve using a commercially available Abbott or Medtronic transcatheter heart valve
• Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures
• Willing and able to comply with the protocol-specified procedures and assessments
• Subject anatomy is compatible with correct device deployment and positioning with:
• Ability to achieve access with a 21 French equivalent femoral access sheath
• Ascending aorta length ≥8 cm
• Ascending aorta/aortic arch diameter is ≥25 or ≤40 mm
• Ascending aorta or aortic arch exhibits ≤ Grade 1 atheromatous disease and limited wall calcification

You may not qualify if:

• Requires urgent or emergent TAVR procedure
• Contraindicated to MRI
• Previously implanted aortic or mitral valve bioprosthesis
• Hepatic failure (Child-Pugh class C)
• Hypercoagulable state that cannot be corrected by additional periprocedural heparin
• Planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 30 days prior to the TAVR procedure. NOTE: Diagnostic cardiac catheterization is permitted up until baseline MRI is obtained. Once baseline MRI is obtained, no additional intra-aortic or intracardiac procedure may occur.
• Acute myocardial infarction within 30 days of the planned index procedure
• Renal failure, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min
• Documented history of stroke or TIA within the prior 6 months, or any prior stroke with a permanent major disability or deficit (NIHSS \>1 at baseline)
• Left ventricular ejection fraction ≤30% within 3 months prior to procedure
• History of intolerance, allergic reaction, or contraindication to any of the study medications, including heparin, aspirin, clopidogrel, or a sensitivity to contrast media or anesthesia that cannot be adequately pre-treated
• Known allergy or sensitivity to nickel-titanium
• Active endocarditis or ongoing systemic infection, defined as fever (\>38°C) and/or white blood cell (WBC) \>15,000 IU
• Undergoing therapeutic thrombolysis
• History of bleeding diathesis or a coagulopathy

Sponsors & Collaborators

• EmStop Inc: lead
• Bright Research Partners: collaborator

Study Sites (2)

Mission Health

Asheville, North Carolina, 28801, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Phil Ebeling, CEO
• Organization: EmStop, Inc.

phil.ebeling@emstopeps.com

763-227-9954

Study Officials

• Emily Vollbrecht

  Bright Research Partners

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 27, 2023
• Study Start: December 27, 2023
• Primary Completion: September 4, 2024
• Study Completion: October 14, 2024
• Last Updated: April 29, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)