Cerebral Embolic Protection Device During TAVR

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: Completed
• Conditions: Cerebral Embolicprotection Device; TAVR
• Intervention / Treatment: Device: Cerebral embolic protection device

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: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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.	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

• Sponsor: Shanghai Shenqi Medical Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Actual): April 16, 2025
• Study Completion (Actual): April 16, 2025

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: TAVR; cerebral embolicprotection device
• Other Study ID 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