Controlled Arterial Protection to Ultimately Remove Embolic Material

NCT ID: NCT06103591

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-27
• Study Completion Date: 2024-10-14

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.

Detailed Description

The investigation is a prospective, multi-center, single arm feasibility study. Subjects will undergo treatment with a currently marketed TAVR device and the EmStop Embolic Protection System and will then be followed to 30 days post-procedure. This is a treatment-only feasibility investigation intended to capture and characterize outcomes, especially safety outcomes, with the EmStop System.

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

EmStop Embolic Protection System

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

Group Type: EXPERIMENTAL

The EmStop Embolic Protection System (EmStop System)

Intervention Type: 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.

Interventions

The EmStop Embolic Protection System (EmStop System)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Between 21 and 90 years of age at the time of consent

2. 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

3. Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures

4. Willing and able to comply with the protocol-specified procedures and assessments

5. 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

Exclusion Criteria

1. Requires urgent or emergent TAVR procedure

2. Contraindicated to MRI

3. Previously implanted aortic or mitral valve bioprosthesis

4. Hepatic failure (Child-Pugh class C)

5. Hypercoagulable state that cannot be corrected by additional periprocedural heparin

6. 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.

7. Acute myocardial infarction within 30 days of the planned index procedure

8. Renal failure, defined as estimated glomerular filtration rate (eGFR) <30 mL/min

9. 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)

10. Left ventricular ejection fraction ≤30% within 3 months prior to procedure

11. 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

12. Known allergy or sensitivity to nickel-titanium

13. Active endocarditis or ongoing systemic infection, defined as fever (>38°C) and/or white blood cell (WBC) >15,000 IU

14. Undergoing therapeutic thrombolysis

15. History of bleeding diathesis or a coagulopathy

16. Known or suspected to be pregnant, or is lactating; female subjects of child-bearing potential must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure.

17. Currently participating in another drug or device clinical study

18. Any other clinical reason, as deemed by the investigators of the study, by which the patient would not be an appropriate candidate for the study

19. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bright Research Partners

INDUSTRY

Sponsor Role: collaborator

EmStop Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Vollbrecht

Role: STUDY_DIRECTOR

Bright Research Partners

Locations

Mission Health

Asheville, North Carolina, United States

Centennial Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EMS-CL-5000

Identifier Type: -

Identifier Source: org_study_id