Aortic valve stenosis
Conditions
Interventions
Test group:Antithrombotic Cerebral Protection Device (ReSong [Shanghai] Medical Technology Co., Ltd.)
Control group:Antithrombotic Cerebral Protection Device, Sentinel Cerebral Protection System (Boston Scientific)
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Males aged >=18 years or non-pregnant females; 2. Symptomatic patients with severe aortic stenosis scheduled for TAVR using a domestically marketed transcatheter aortic valve system; 3. Patients with a left common carotid artery diameter of 6.5–10 mm and a brachiocephalic artery diameter of 9–15 mm, both without significant stenosis (>70%); 4. Patients capable of understanding the study objectives, voluntarily participating and signing the informed consent form, and willing to undergo relevant examinations and clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. Factors precluding MRI examination exist, or the implantable devices planned for this procedure are incompatible with MRI; or implantation of an MRI-incompatible pacemaker or defibrillator is scheduled within 30 days postoperatively; 2. Patients with an NIHSS score >0 or mRS score =2; 3. Acute myocardial infarction within 30 days prior to surgery; 4. Patients with isolated aortic valve regurgitation; 5. Any therapeutic cardiac surgery or interventional procedure (excluding angiography) within 30 days prior to surgery; 6. Patients requiring any additional cardiac surgery or interventional procedure during TAVR (excluding coronary artery protection during TAVR); 7. Previous implantation of an artificial aortic valve; 8. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) =20%; 9. Echocardiographic evidence of intracardiac masses, thrombi, or vegetations; 10. Stroke or transient ischaemic attack (TIA) within 6 months prior to surgery; 11. Renal insufficiency (endogenous creatinine clearance 70%), dilatation, or dissection of the brachiocephalic or left carotid arteries; or those with aneurysms at the aortic root or within 3 cm of the aortic root; 24. Presence of severe peripheral arterial disease (e.g., significant stenosis/sinusoidal tortuosity) preventing device access or smooth passage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of being free from major adverse cardiovascular and cerebrovascular events (MACCE) within 30 days post-surgery;Diffusion-weighted MRI (DW-MRI) performed 2-7 days postoperatively to assess the total volume of new cerebral infarct lesions within protected brain areas (TLV, mm^3); | — |
Secondary
| Measure | Time frame |
|---|---|
| Equipment success rate;Surgical success rate;Histopathological analysis of captured thrombi/fragments, including thrombus/fragment type, number, and size;Incidence of major adverse cardiovascular and cerebrovascular events before discharge;Incidence of device defects;Evaluate the protected brain regions, the number of new cerebral infarcts, and the total volume in the whole brain using DW-MRI within 2-7 days postoperatively.;At 30 days post-surgery, FLAIR-MRI was used to assess the protected areas of the brain, the number of new cerebral infarcts in the whole brain, and the total volume.;Changes in mRS and NIHSS scores compared to baseline before discharge and 30 days postoperatively;All-cause mortality before discharge and within 30 days postoperatively, incidence of disabling or non-disabling stroke, incidence of acute kidney injury stage 3 or higher, and incidence of serious vascular complications;Overall incidence of AE and SAE; | — |
Countries
China
Contacts
Public ContactJunbo Ge
Zhongshan Hospital, Fudan University
Outcome results
None listed