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New treatment option for Aortic Valve Stenosis
Official title CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material
ClinicalTrials.gov ID: NCT07276711
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Clinical 1. Age ≥ 22 years at the time of consent
- Meets FDA-approved indications for elective transfemoral self-expanding transcatheter aortic valve replacement (TAVR) procedure on a native or...
- Left ventricular ejection fraction ≥ 30% as confirmed by echocardiogram
- 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 Imaging 1. Echocardiogram including left ventricular ejection...
You likely can't join if
- Requires use of a balloon-expandable transcatheter aortic valve for the index procedure
- Documented history of stroke or transient ischemic attack (TIA) within the prior 6 months, or any prior stroke with a permanent major disability or...
- Left ventricular ejection fraction \<30%, cardiogenic shock, or hypotension requiring inotropes or mechanical circulatory support, within 3 months...
- Acute myocardial infarction (MI) within 30 days of the planned index procedure
- Planned to undergo any other open cardiac surgical or left heart treatment procedure (e.g., concurrent coronary revascularization) during the TAVR...
- Renal failure, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min
See the full eligibility criteria
Who can join
- Clinical 1. Age ≥ 22 years at the time of consent
- 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...
- Left ventricular ejection fraction ≥ 30% as confirmed by echocardiogram
- 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 Imaging 1. Echocardiogram including left ventricular ejection fraction ≥ 30% within 6 months (180 days) prior to the index procedure and...
- people 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...
- 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) 1\. Subject anatomy, excluding bovine arch anatomy, is compatible with correct device...
- 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
What rules you out
- Requires use of a balloon-expandable transcatheter aortic valve for the index procedure
- 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...
- Left ventricular ejection fraction \<30%, cardiogenic shock, or hypotension requiring inotropes or mechanical circulatory support, within 3 months prior to index procedure
- Acute myocardial infarction (MI) within 30 days of the planned index procedure
- Planned to undergo any other open cardiac surgical or left heart treatment procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 30 days prior to the TAVR procedure. The need for a...
- Renal failure, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min
- Hypercoagulable state that cannot be corrected by additional periprocedural heparin
- 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...
- Undergoing therapeutic thrombolysis
- History of bleeding diathesis or major coagulopathy
- Hepatic failure (Child-Pugh class C)
- Active endocarditis or ongoing systemic infection, defined as fever (\>38°C) and/or WBC \>15,000 IU
- Known allergy to any materials used in the EmStop system (e.g., nitinol)
- Currently participating in another drug or device clinical study
- 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
- Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
- Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study
The study team makes the final eligibility decision.
Where it's taking place
- New Orleans, Louisiana, United States
- Asheville, North Carolina, United States
- Rapid City, South Dakota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Orleans, Louisiana, United States; Asheville, North Carolina, United States; Rapid City, South Dakota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.