N/A
Completed N=15
Controlled Arterial Protection to Ultimately Remove Embolic Material
Source: ClinicalTrials.gov NCT06103591 ↗Enrolled (actual)
15
Serious AEs
40.0%
Results posted
Apr 2025
Primary outcomePrimary: Number of Participants With Procedural Success — 14 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Procedural Success |
14 | — |
| PRIMARY Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days |
1; 1; 0 | — |
| SECONDARY Average Number of Captured Embolic Debris |
3169.00 | — |
| SECONDARY Average Number of Captured Particles ≥140 μm in Diameter |
3169.00 | — |
| SECONDARY Total Acute Infarct Burden |
14.93 | — |
| SECONDARY Occurrence of Transient Ischemic Attack (TIA) |
— | — |
Eligibility Criteria
Inclusion Criteria
Clinical & Angiographic Inclusion Criteria
- 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
Exclusion Criteria
- 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) 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
- 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.
- Currently participating in another drug or device clinical study
- 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
- Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
Data sourced from ClinicalTrials.gov (NCT06103591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.