Cerebral Embolicprotection DeviceNCT07627984
Cerebral Embolic Protection Device During TAVR
A study testing Cerebral embolic protection device in people with Cerebral Embolicprotection Device and TAVR, run by Shanghai Shenqi Medical Technology Co., Ltd at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Embolicprotection Device, TAVR
- What is being tested?
- Cerebral embolic protection device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2023to 16 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, male or non-pregnant/non-lactating female.
- Suitable for TAVR and planned to undergo TAVR using an approved transcatheter aortic valve system.
- TAVR access limited to transfemoral or transapical approach.
- 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.
- No severe stenosis (>70%), dilation, dissection, ostial aneurysm, or aneurysm within 3 cm of the aortic origin in the target vessels.
- Brain imaging evaluable by 3-Tesla magnetic resonance imaging.
- Willing to comply with protocol-required follow-up assessments.
- Written informed consent provided by the subject or legal guardian.
Who cannot join
- Impaired right upper limb blood flow.
- Intracranial hemorrhage, stroke, or transient ischemic attack within 6 months before procedure.
- Acute myocardial infarction within 1 month before procedure.
- Calcification in the intended filter deployment region.
- Planned pacemaker or defibrillator implantation within 30 days after TAVR.
- Left ventricular ejection fraction ≤20%.
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- Infective endocarditis, intracardiac/aortic mass, thrombus, or vegetation on echocardiography.
- Severe occlusive carotid disease requiring concomitant carotid intervention, or carotid stenting/endarterectomy within 6 weeks.
- Leukopenia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulation disorder.
- Active peptic ulcer disease or gastrointestinal bleeding within 3 months.
- Severe allergy or known contraindication to nitinol, stainless steel alloy, or contrast media.
- Contraindication to antiplatelet and/or anticoagulation therapy, or refusal of blood transfusion.
- Severe renal insufficiency (serum creatinine >3.0 mg/dL, eGFR <30 mL/min, or need for renal replacement therapy).
- Known psychiatric disease or substance abuse that may interfere with compliance or data interpretation.
- Life expectancy <1 year.
- Active infection requiring concurrent antibiotic therapy.
- Other clinical conditions preventing compliance with the instructions for use of the investigational device.
- Concurrent use or planned use of another investigational device or drug during the study period.
- Severe tortuosity of right upper extremity vessels or inability to accommodate a 6 F sheath.
- Contraindication to MRI, including implanted pacemaker/defibrillator, metal implants, metal fragments, clips, or intracranial/ocular implanted devices.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Cerebral Embolicprotection Device, TAVR
- Being tested
- Cerebral embolic protection device
- Keywords
- cerebral embolicprotection device, TAVR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral embolic protection deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Use of a cerebral embolic protection device during TAVR | Experimental | Use of a cerebral embolic protection device during TAVR Receives: Device: Cerebral embolic protection device |
| TAVR without the use of a cerebral embolic protection device | No intervention | TAVR without the use of a cerebral embolic protection device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 2±1 days after TAVR.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start20 Sep 2023
- Primary completion16 Apr 2025
- Study completion16 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Embolicprotection DeviceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627984
- Sponsor's protocol ID
- CEPD01-001
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07627984
- Acronym / sponsor ID
- CEPD01-001
- Conditions
- Cerebral Embolicprotection Device, TAVR
- Keywords
- cerebral embolicprotection device, TAVR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Shanghai Shenqi Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of a cerebral embolic protection device during TAVR | Experimental | Device: Cerebral embolic protection deviceUse of a cerebral embolic protection device during TAVR |
| TAVR without the use of a cerebral embolic protection device | No intervention | –TAVR without the use of a cerebral embolic protection device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years, male or non-pregnant/non-lactating female.
- Suitable for TAVR and planned to undergo TAVR using an approved transcatheter aortic valve system.
- TAVR access limited to transfemoral or transapical approach.
- 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.
- No severe stenosis (>70%), dilation, dissection, ostial aneurysm, or aneurysm within 3 cm of the aortic origin in the target vessels.
Key exclusion criteria (20 listed)
- Impaired right upper limb blood flow.
- Intracranial hemorrhage, stroke, or transient ischemic attack within 6 months before procedure.
- Acute myocardial infarction within 1 month before procedure.
- Calcification in the intended filter deployment region.
- Planned pacemaker or defibrillator implantation within 30 days after TAVR.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral embolic protection deviceThe 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. | Device | Use of a cerebral embolic protection device during TAVR |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral embolic protection device in people with Cerebral Embolicprotection Device and TAVR, run by Shanghai Shenqi Medical Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.