Type B Aortic Dissection Quality Control Platform

Official title

Construction of Type B Aortic Dissection Quality Control Platform and Risk Prediction Mechanism

Overview

This study aims to establish a multicenter, prospective, observational registry database for type B aortic dissection based on approximately 60 regional sentinel hospitals across China. It develops a digital intelligent management system, formulates quality control indicators and data collection standards for type B aortic dissection, and optimizes the data quality control and evaluation system to realize comprehensive evaluation covering the entire diagnosis and treatment process and long-term prognosis. Artificial intelligence algorithms are adopted to construct a risk prediction model for adverse events, and auxiliary decision-making software is developed to identify potential risks of adverse events in a timely manner and establish an early warning system, ultimately reducing the in-hospital complication and mortality rates. Relying on the National Quality Control Platform for Peripheral Vascular Intervention, this study further builds a national quality control platform for type B aortic dissection covering more than 5,000 hospitals nationwide by establishing a three-level quality control system. By integrating health administrative data, quality control data, electronic medical record data and clinical research data, a high-quality, multi-dimensional national quality control platform is constructed to support the sustainable development of quality control work. In addition, a clinical research collaboration network will be established to conduct in-depth evaluation of the national diagnosis and treatment patterns and outcomes of type B aortic dissection. Regular national training and assessment programs will be organized to improve the overall diagnosis and treatment capacity of medical institutions at all levels and reduce regional and institutional disparities in the quality of clinical care for the disease.

Interventions

• Procedure Endo vascular repair
  This is an observational study, and the intervention is the routine and standard care for patients.

Primary outcome measures

• Number of major adverse events [Time frame: From surgery completion to 30 days after surgery completion]

Secondary outcome measures (7)

• Number of participants with adverse events [Time frame: From surgery completion to 6, 12 and 24 months after surgery completion]
• The change of distal true lumen diameter (unit: mm) [Time frame: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion]
• The change of distal false lumen diameter (unit: mm) [Time frame: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion]
• The number of false lumen thrombosis [Time frame: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion]
• The maximum aortic diameter at the dissected thoracic aortic segment [Time frame: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion]
• The maximum aortic diameter at the diaphragmatic level (unit: mm) [Time frame: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion]
• Maximum diameter of the abdominal aortic segment affected by dissection (unit: mm) [Time frame: From surgery completion to 30 days, 6 months, 12 month, and 24 months after surgery completion]

Eligibility criteria

Inclusion criteria

• Aged between 18 and 80 years (inclusive);
• Definite diagnosis of Stanford type B aortic dissection confirmed by three-dimensional CTA reconstruction;
• Underwent TEVAR, including standalone TEVAR and hybrid procedures (only non-thoracotomy hybrid procedures);
• Patients and their families signed informed consent and agreed to complete the 2-year full follow-up.

Exclusion criteria

• Presence of severe comorbidities or other diseases (e.g., severe chronic obstructive pulmonary disease, malignant tumors, dementia) or any physical condition that may affect patient compliance with this study;
• A previous history of thoracic aortic surgery (including TEVAR, hybrid surgery, and open surgery);
• Congenital aortic malformations;
• Requiring concurrent intervention for cardiac or aortic sinus root lesions, or cardiac diseases that would alter the postoperative medication regimen;
• Pregnant or breastfeeding women;
• Complicated with Stanford type A intramural hematoma, supra-aortic vessel occlusion, or refusal of relevant repair;
• A history of stroke or acute myocardial infarction within 30 days prior to surgery;
• Receipt of any major surgical or interventional procedures within 30 days prior to surgery;
• Scheduled to undergo any major elective surgical or interventional procedures within 30 days after index surgery;
• Participation in other ongoing drug or device trials with unmet primary study endpoints.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07745309 · FW2024-2503

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗