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

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

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.

Study Overview

• Status: Unknown
• Conditions: Ascending Aortic Dissection
• Intervention / Treatment: Device: Stent grafts anchored in different areas

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Zaiping Jing, professor; Phone Number: 02131161670; Email: xueguanky@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This clinical trial included a prospective study of patients admitted to the hospital with aortic dissection between October 2020 and September 2023 who were treated with an endoluminal graft after exclusion of surgical contraindications.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ascending aortic dissection patients	Device: Stent grafts anchored in different areas; Endovascular repair of ascending aortic dissection patients with stent grafts anchored in different areas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success of operation	The operation was completed successfully without complications.	before December 2022

Collaborators and Investigators

• Sponsor: Chinese Medical Association
• Collaborators: Changhai Hospital
• Investigators: Principal Investigator: Zaiping Jing, Professor, Vascular surgery, Changhai Hospital

Publications and helpful links

General Publications

• Pei Y, Zhu H, Xiao Y, Zhou J, Jing Z. The Mini-Cross Prefenestration for Endovascular Repair of Aortic Arch Pathologies. Front Cardiovasc Med. 2022 Jan 11;8:745871. doi: 10.3389/fcvm.2021.745871. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: https://orcid.org/0000-0002-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No