NCT07276711 CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material
| NCT ID | NCT07276711 |
| Status | Recruiting |
| Phase | — |
| Sponsor | EmStop Inc |
| Condition | Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 663 participants |
| Start Date | 2026-05-12 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 663 participants in total. It began in 2026-05-12 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus/debris during self-expanding transcatheter aortic valve replacement (TAVR) procedures.
Eligibility Criteria
Clinical Inclusion Criteria 1. Age ≥ 22 years at the time of consent 2. Meets FDA-approved indications for elective transfemoral self-expanding transcatheter aortic valve replacement (TAVR) procedure on a native or non-native (valve-in-valve) aortic valve. Note: Due to Neurologist availability and importance of capturing the neurological assessments, procedures must be performed Monday-Thursday. 3. Left ventricular ejection fraction ≥ 30% as confirmed by echocardiogram 4. Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures 5. Willing and able to comply with the protocol-specified procedures and assessments Imaging Inclusion Criteria 1. Echocardiogram including left ventricular ejection fraction ≥ 30% within 6 months (180 days) prior to the index procedure and prior to randomization to confirm adequate cardiac function. 2. Subjects must undergo a computed tomography angiography (CTA) scan within 6 months (180 days) prior to the index procedure and prior to randomization to confirm anatomic compatibility with the study device and the control device. Subjects must meet the following anatomical inclusion criteria: EmStop Angiographic (CTA) Inclusion Criteria 1. Subject anatomy is compatible with correct device positioning with: * Ascending aorta length ≥8 cm * Femoral and iliac artery minimal lumen diameter of ≥ 8.0 mm * Ascending aorta/aortic arch diameter is ≥25 or ≤40 mm. * Ascending aorta or aortic arch exhibits ≤ Grade 1 atheromatous disease and limited wall calcification Sentinel Angiographic (CTA) Inclusion Criteria 1\. Subject anatomy, excluding bovine arch anatomy, is compatible with correct device positioning with: * Artery diameter is 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery * Arterial stenosis \<70% in either the left common carotid artery or the brachiocephalic artery * Brachiocephalic or left carotid artery without significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium * Adequate blood flow to the right upper extremity * Access vessels without excessive tortuosity Exclusion Criteria: 1. Requires use of a balloon-expandable transcatheter aortic valve for the index procedure 2. Documented history of stroke or transient ischemic attack (TIA) within the prior 6 months, or any prior stroke with a permanent major disability or deficit (National Institute of Health Stroke Scale \[NIHSS\] \>1 at baseline) 3. Left ventricular ejection fraction \<30%, cardiogenic shock, or hypotension requiring inotropes or mechanical circulatory support, within 3 months prior to index procedure 4. Acute myocardial infarction (MI) within 30 days of the planned index procedure 5. Planned to undergo any other open cardiac surgical or left heart interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 30 days prior to the TAVR procedure. The need for a postoperative pacemaker implant after TAVR is not exclusionary. 6. Renal failure, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min 7. Hypercoagulable state that cannot be corrected by additional periprocedural heparin 8. 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 9. Undergoing therapeutic thrombolysis 10. History of bleeding diathesis or major coagulopathy 11. Hepatic failure (Child-Pugh class C) 12. Active endocarditis or ongoing systemic infection, defined as fever (\>38°C) and/or WBC \>15,000 IU 13. Known allergy to any materials used in the EmStop system (e.g., nitinol) 14. Currently participating in another drug or device clinical study 15. Known or suspected to be pregnant, or is lactating; women of child bearing age must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure 16. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults) 17. Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study
Contact & Investigator
Stanley J Chetcuti, MD
PRINCIPAL INVESTIGATOR
University of Michigan Health
Frequently Asked Questions
Who can join the NCT07276711 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07276711 currently recruiting?
Yes, NCT07276711 is actively recruiting participants. Contact the research team at k.vo@emstopeps.com for enrollment information.
Where is the NCT07276711 trial being conducted?
This trial is being conducted at New Orleans, United States, Asheville, United States, Rapid City, United States.
Who is sponsoring the NCT07276711 clinical trial?
NCT07276711 is sponsored by EmStop Inc. The principal investigator is Stanley J Chetcuti, MD at University of Michigan Health. The trial plans to enroll 663 participants.