Controlled Arterial Protection to Ultimately Remove Embolic Material (CAPTURE-1)

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: The EmStop Embolic Protection System (EmStop System)

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scott Thome; Phone Number: 320-420-1992; Email: thome.scott62@gmail.com
• Study Contact Backup: Name: Emily Vollbrecht; Phone Number: 612-345-4544; Email: evollbrecht@brightresearchpartners.com

Study Locations

• United States
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Recruiting
      • Mission Health
      • Principal Investigator: Michael Chenier, MD
      • Contact: Christi Riggsbee; Phone Number: 828-213-5632
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Not yet recruiting
      • Centennial Medical Center
      • Principal Investigator: Andrew Goodman, MD
      • Contact: Hannah Vaughn; Phone Number: 615-981-1689

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Clinical & Angiographic 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EmStop Embolic Protection System; Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System).	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device procedural success	Defined as successful insertion, deployment, positioning, and removal of the EmStop System in the absence of device interference	Procedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross and histologic evaluation of captured embolic debris	Assessed by an independent pathology core laboratory	Procedural
Average number of captured particles ≥140 μm in diameter	Assessed by an independent pathology core laboratory	Procedural
Total acute infarct burden	As measured by diffusion-weighted imaging (DWI), also referred to as DW-MRI. This outcome will be evaluated and tabulated to include total lesion count, average (mean) lesion volume and median lesion volume.	14 days pre-procedure and at 18-36 hours post-procedure
Occurrence of Transient Ischemic Attack (TIA)		30 days

Collaborators and Investigators

• Sponsor: EmStop Inc
• Collaborators: Bright Research Partners
• Investigators: Study Director: Emily Vollbrecht, Bright Research Partners

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Aortic Valve Replacement; Transcatheter Aortic Valve Replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: EMS-CL-5000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes