Cerebral Embolicprotection Device, TAVR
Conditions
Keywords
cerebral embolicprotection device, TAVR
Brief 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).
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.
Interventions
DEVICECerebral 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.
Sponsors
Shanghai Shenqi Medical Technology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
China
Outcome results
None listed