Health TrialsbyHealthPanel

CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material

ConditionsAortic Valve StenosisAortic StenosisAortic Valve Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorEmStop Inc

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

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

Disqualifiers

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 baseline)

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • EmStop Embolic Protection System

    Device

    EmStop Embolic Protection System used during TAVR procedure

  • Boston Scientific Sentinel

    Device

    Sentinel device used during TAVR procedure

Treatment groups

663 Participants
are divided into 2 treatment groups
Group A: EmStop SystemExperimental treatment 1 intervention
Group B: Boston Scientific Sentinel deviceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Non-Inferiority

Primary combined safety and efficacy endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30-days

Time frame
Non-inferiority of 30-day EmStop device MACCE patient incidence rate compared to the Sentinel device patient incidence rate

Secondary outcomes

1

Non-Inferiority

Hypothesis-driven secondary efficacy endpoint is the composite rate through 30-days post-procedure of NeuroARC defined ischemic embolic stroke, VARC-3 defined AKI, and systemic embolization

Time frame
30 days
2

Debris Capture

Hypothesis-driven secondary efficacy endpoint is the total debris capture, defined as the number of captured particles of at least ≥ 150micron

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EmStop Inc

Lead sponsor

Bright Research Partners

Collaborator

Source ClinicalTrials.gov
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