Aortic root replacement
Conditions
Interventions
Experimental Group:Aortic root replacement
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: (1) Aged 18 to 75 years, with no gender restrictions; (2) Patients requiring aortic root replacement; (3) Able to understand the purpose of the trial, willing to participate voluntarily, sign the informed consent form, and accept vascular implantation and clinical follow-up.
Exclusion criteria
Exclusion criteria: Exclusion criteria (1) Subjects who underwent open surgery on the cardiovascular or cerebrovascular system within 3 months prior to screening; (2) Subjects planning to undergo coronary artery bypass grafting or establish hemodialysis access; (3) Subjects with active systemic infection; (4) Subjects with sepsis, active bleeding, refusal to receive blood transfusion, or coagulation dysfunction [Coagulation dysfunction is defined as: 1) Platelet count (PLT) 2.5 times the upper limit of normal]; (5) Subjects known to be allergic to polyester, bovine-derived products, or heparin; (6) Subjects unable to tolerate general anesthesia and cardiopulmonary bypass; (7) Subjects with an expected life expectancy < 6 months (excluding diseases caused by aortic dissection); (8) Subjects currently participating or planning to participate in other clinical studies involving drugs or devices during the trial period; (9) Subjects in pregnancy or lactation, or planning to become pregnant during the study period; (10) Other situations deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rate [12 months after surgery]; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patency rate of artificial blood vessels (from post-operation to discharge, and at 6 months);Structural integrity rate of artificial blood vessels (from postoperative to discharge, and at 6 months);Device success rate (immediately after surgery);Intraoperative blood loss;Intraoperative blood transfusion volume;Length of hospital stay;ICU time;Extracorporeal circulation time;Changes in hemodynamic indicators; | — |
Countries
China
Contacts
Public ContactYang Yan
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed