Endovascular Graft Anchoring Different Regions of Ascending Aorta in the Treatment of Ascending Aortic Dissection

• Conditions: Ascending Aortic Dissection
• Interventions: Device: Stent grafts anchored in different areas

• Registration Number: NCT04544579
• Lead Sponsor: Chinese Medical Association

Brief Summary

Aortic dissection is a deadly and dangerous disease. About 28% of patients with ascending aortic dissection can't tolerate open surgical trauma caused by thoracotomy and cardiopulmonary bypass, and the prognosis is poor. Minimally invasive endovascular treatment has been applied in the treatment of descending aortic dissection. However, due to the special anatomical structure and high speed /pressure blood flow, the treatment of ascending aorta dissection has become an international difficulty.

Detailed Description

This study was designed combination of retrospective and prospective methods, and focused on distal false lumen Aneurysmal Expansion of Aortic Dissection (DAEAD) . To formulate clinical data for the risk assessment of DAEAD, and best intracavitary treatment or long-term efficacy evaluation, we combined the results of genetic testing, evaluating the missense mutation, computer simulation of blood flow dynamics analysis, and clinical imaging analysis.

Study Timeline

• Study First Submitted: 2020-08-26
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-03
• Last Update Submitted: 2020-09-03
• Study First Posted: 2020-09-10
• Last Update Posted: 2020-09-10
• Study Start: 2020-10-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Aortic dissection diagnosed by CTA;
• With indications for endovascular treatment
• The luminal graft anchor is required to be located in the ascending aorta.

Exclusion Criteria

• Import difficult, such as external iliac artery diameter is less than 6 mm bilateral iliac, artery stenosis distortions;
• Patients with severe comorbidities, such as severe myocardial insufficient blood supply, heart failure, arrhythmia, severe renal dysfunction, and severe blood coagulation dysfunction;
• Patients with malignant tumor, or other serious illness, life expectancy of less than 1 year；
• Puncture local infection and high fever;⑤ within 1 month of the large area;
• Contrast media in patients with cerebrovascular accident or digestive tract hemorrhage patients with allergies;
• Aortic ulcer or aortic wall hematoma and other atypical dissection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ascending aortic dissection patients	Stent grafts anchored in different areas	Ascending aortic dissection patients

Primary Outcome Measures

Name	Time	Method
success of operation	before December 2022	The operation was completed successfully without complications.