Cerebral Embolic Protection Device During TAVR

June 2, 2026 updated by: Shanghai Shenqi Medical Technology Co., Ltd

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of a Cerebral Embolic Protection Device for Capturing and Removing Thrombus/Tissue Debris During Transcatheter Aortic Valve Replacement

To evaluate the safety and effectiveness of the Cerebral Protection System (model CEP016F, Shanghai Shenqi Medical Technology Co., Ltd.) for capturing and removing thrombotic and tissue debris during transcatheter aortic valve replacement (TAVR).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a prospective, multicenter, randomized controlled clinical trial designed to evaluate the safety and effectiveness of the Cerebral Protection System (model CEP016F, Shanghai Shenqi Medical Technology Co., Ltd.) for capturing and removing thrombotic and tissue debris during transcatheter aortic valve replacement (TAVR). The target study population includes adult patients who are suitable for TAVR using commercially available domestic transcatheter aortic valve systems and whose vascular anatomy is appropriate for placement of the device in the brachiocephalic artery and left common carotid artery. The planned sample size is 260 subjects. Eligible subjects will be randomized in a 1:1 ratio to the device group (TAVR with the cerebral protection system) or the control group (TAVR without the device) using a centralized stratified randomization system based on valve type (self-expanding or balloon-expandable). All subjects are planned to undergo follow-up within 24 hours after procedure, at 2±1 days, at 48-72 hours or before discharge (whichever comes first), and at 30 days after TAVR.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Xiamen, China
        • Xiamen Cardiovascular Hospital Xiamen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years, male or non-pregnant/non-lactating female.
  2. Suitable for TAVR and planned to undergo TAVR using an approved transcatheter aortic valve system.
  3. TAVR access limited to transfemoral or transapical approach.
  4. Imaging-confirmed left common carotid artery diameter of 6.5-10 mm and brachiocephalic artery diameter of 9-15 mm at the site of filter placement.
  5. No severe stenosis (>70%), dilation, dissection, ostial aneurysm, or aneurysm within 3 cm of the aortic origin in the target vessels.
  6. Brain imaging evaluable by 3-Tesla magnetic resonance imaging.
  7. Willing to comply with protocol-required follow-up assessments.
  8. Written informed consent provided by the subject or legal guardian.

Exclusion Criteria:

  1. Impaired right upper limb blood flow.
  2. Intracranial hemorrhage, stroke, or transient ischemic attack within 6 months before procedure.
  3. Acute myocardial infarction within 1 month before procedure.
  4. Calcification in the intended filter deployment region.
  5. Planned pacemaker or defibrillator implantation within 30 days after TAVR.
  6. Left ventricular ejection fraction ≤20%.
  7. Infective endocarditis, intracardiac/aortic mass, thrombus, or vegetation on echocardiography.
  8. Severe occlusive carotid disease requiring concomitant carotid intervention, or carotid stenting/endarterectomy within 6 weeks.
  9. Leukopenia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulation disorder.
  10. Active peptic ulcer disease or gastrointestinal bleeding within 3 months.
  11. Severe allergy or known contraindication to nitinol, stainless steel alloy, or contrast media.
  12. Contraindication to antiplatelet and/or anticoagulation therapy, or refusal of blood transfusion.
  13. Severe renal insufficiency (serum creatinine >3.0 mg/dL, eGFR <30 mL/min, or need for renal replacement therapy).
  14. Known psychiatric disease or substance abuse that may interfere with compliance or data interpretation.
  15. Life expectancy <1 year.
  16. Active infection requiring concurrent antibiotic therapy.
  17. Other clinical conditions preventing compliance with the instructions for use of the investigational device.
  18. Concurrent use or planned use of another investigational device or drug during the study period.
  19. Severe tortuosity of right upper extremity vessels or inability to accommodate a 6 F sheath.
  20. Contraindication to MRI, including implanted pacemaker/defibrillator, metal implants, metal fragments, clips, or intracranial/ocular implanted devices.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Use of a cerebral embolic protection device during TAVR
Device: Cerebral embolic protection device
The cerebral embolic protection device is a percutaneously delivered dual-filter protection device designed to capture and remove dislodged debris during transcatheter aortic valve replacement (TAVR). The system utilizes one filter delivered to the brachiocephalic trunk (proximal filter) and a second filter delivered to the left common carotid artery (distal filter). Upon completion of the procedure, the filters and debris are retrieved back into the catheter and removed from the patient.
No Intervention: TAVR without the use of a cerebral embolic protection device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The median total volume of new lesions within the protected brain territories, as assessed by diffusion-weighted magnetic resonance imaging (DW-MRI) at 2±1 days after TAVR.
Time Frame: At 2±1 days after TAVR.
Protected brain territories are defined as the cerebral regions perfused exclusively by the vessels protected by the cerebral embolic protection device, namely the brachiocephalic artery and the left common carotid artery. Total volume of new lesions is defined as the sum of all newly detected diffusion-positive brain lesions on post-TAVR DW-MRI relative to pre-TAVR DW-MRI.
At 2±1 days after TAVR.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Shenqi Medical Technology Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEPD01-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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