None listed
Conditions
Interventions
experimental group: TriGUARD 3 Cerebral Embolic Protection Device
Sponsors
General Hospital of Norther Theater Command
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or non pregnant female over 18 years old; 2. Those patients who are suitable for TAVR and plan to use Venus a valve for TAVR; 3. Patients who are willing to accept the follow-up evaluation specified in the protocol. 4. The patients or their legal representatives who participated in the study have been informed of the nature of the study, agreed with the study regulations and provided written informed consent approved by EC of their respective clinical trial institutions.
Exclusion criteria
Exclusion criteria: 1.Patients undergoing TAVI via the trans-apical, trans-axillary, trans-subclavian, or trans-aortic route. 2.Patients with a previously implanted prosthetic aortic valve (i.e., planned valve-in-valve TAVI). 3.Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 14 days prior to index procedure per site standard test. 4.Patients with known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (according to definition) or AMI >72 hours preceding the index procedure, in whom CK and CK-MB have not returned to within normal limits at the time of procedure, or patients who are currently experiencing clinical symptoms consistent with new-onset AMI, such as nitrate-unresponsive prolonged chest pain. 5.Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, patients who will refuse transfusion, or patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months. 6.Patients with known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year. 7.Patients with severe allergy or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated. 8.Patients with a history of a stroke or transient ischemic attack (TIA) within the prior year. 9.Patients with renal failure (estimated Glomerular Filtration Rate [eGFR] <30 mL/min calculated from serum creatinine by the Cockcroft-Gault formula or the Modification of Diet in Renal Disease formula). 10.Patients with hepatic failure (Child-Pugh class C). 11.Patients with hypercoagulable states that cannot be corrected by additional peri-procedural heparin. 12.Patients presenting with cardiogenic shock at the time of the index procedure. 13.Patients with severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath vascular access. 14.Patients in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous. 15.Patients with any other condition that would prevent adherence to the TriGUARD 3 Instructions for Use. 16.Patients who have a planned treatment with any other investigational device or procedure during the study period. 17.Patients planned to undergo any other cardiac surgical or interventional procedure during the TAVI procedure or within 10 days prior to the TAVI procedure. (NOTE: Diagnostic cardiac catheterization is permitted within 10 days prior to the TAVI procedure. Patients planned to undergo preventive coronary stenting during TAVI because they are deemed at high risk for coronary artery obstruction by the TAVI device are permitted to be enrolled.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device related safety, defined as the composite of the following Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) adjudicated as related to the investigational device, evaluated immediately prior to discharge from index procedure hospitalization or at 7 days post procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Second Endpoint: Primary Device efficacy measured as numerical reduction of the mean total lesion volume (TLV, mm3) of lesions >400 mm3 (clinically meaningful lesions) with full coverage of all three (3) cerebral branches based on REFLECT phase 2 data of 272 mm3; | — |
Countries
China
Contacts
Public ContactCong Ma
Venus Medtech (Hangzhou) Inc.
Outcome results
None listed