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

NCT04544579 | Unknown

• 1 other identifier: https://orcid.org/0000-0002-07
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ascending Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• success of operation

  The operation was completed successfully without complications.

  before December 2022

Study Arms (1)

Ascending aortic dissection patients

Ascending aortic dissection patients

Device: Stent grafts anchored in different areas

Interventions

Stent grafts anchored in different areas DEVICE

Endovascular repair of ascending aortic dissection patients with stent grafts anchored in different areas

Ascending aortic dissection patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Medical Association: lead
• Changhai Hospital: collaborator

Related Publications (1)

• 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.

  PMID: 35087876 DERIVED

MeSH Terms

Conditions

Dissection, Ascending Aorta

Condition Hierarchy (Ancestors)

Dissection, Thoracic Aorta; Aortic Dissection; Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• Zaiping Jing, Professor

  Vascular surgery, Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zaiping Jing, professor

CONTACT

02131161670; xueguanky@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 10, 2020
• Study Start: October 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 30, 2022
• Last Updated: September 10, 2020

Record last verified: 2020-09