Clinical trial NCT04544579: Endovascular Graft Anchoring Different Regions of Ascending Aorta in the Treatment of Ascending Aortic Dissection
Official title: Endovascular Graft Anchoring Different Regions of Ascending Aorta in the Treatment of Ascending Aortic Dissection: a Prospective， Controlled and Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ascending Aortic Dissection
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
Collaborators: name: Changhai Hospital
First posted: 2020-09-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: success of operation
timeFrame: before December 2022
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vascular surgery, Changhai Hospital
name: Zaiping Jing, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.