Clinical trial NCT06103591: Controlled Arterial Protection to Ultimately Remove Embolic Material
Official title: Controlled Arterial Protection to Ultimately Remove Embolic Material
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Transcatheter Aortic Valve Replacement
Aortic Valve Replacement
Lead sponsor: EmStop Inc
Sponsor class: INDUSTRY
Collaborators: name: Bright Research Partners
First posted: 2023-10-27
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Procedural Success
timeFrame: During the procedure
measure: Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days
timeFrame: 30 days follow-up
Secondary outcomes:
measure: Average Number of Captured Embolic Debris
timeFrame: During the procedure
measure: Average Number of Captured Particles ≥140 μm in Diameter
timeFrame: Procedural
measure: Total Acute Infarct Burden
timeFrame: 14 days pre-procedure to 18-36 hours post-procedure
measure: Occurrence of Transient Ischemic Attack (TIA)
timeFrame: 30 days
Other outcomes:
Locations:
city: Asheville
country: United States
facility: Mission Health
state: North Carolina
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
Study officials:
affiliation: Bright Research Partners
name: Emily Vollbrecht
role: STUDY_DIRECTOR
References: