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

Ascending Aortic Dissection Clinical Trial

Official title:

Endovascular Graft Anchoring Different Regions of Ascending Aorta in the Treatment of Ascending Aortic Dissection: a Prospective， Controlled and Multicenter Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04544579
• Other study ID #: https://orcid.org/0000-0002-07
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2020
• Source: Chinese Medical Association
• Contact: Zaiping Jing, professor
• Phone: 02131161670
• Email: xueguanky[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 30, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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;? 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.

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Ascending Aortic Dissection

Intervention

Device:
• Stent grafts anchored in different areas
Endovascular repair of ascending aortic dissection patients with stent grafts anchored in different areas

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Medical Association	Changhai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success of operation	The operation was completed successfully without complications.	before December 2022