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

NCT ID: NCT04544579

Last Updated: 2020-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-09-30

Brief Summary

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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

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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.

Conditions

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Ascending Aortic Dissection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ascending aortic dissection patients

Ascending aortic dissection patients

Stent grafts anchored in different areas

Intervention Type DEVICE

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

Interventions

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Stent grafts anchored in different areas

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role collaborator

Chinese Medical Association

NETWORK

Sponsor Role lead

Responsible Party

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Zaiping Jing

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zaiping Jing, Professor

Role: PRINCIPAL_INVESTIGATOR

Vascular surgery, Changhai Hospital

Central Contacts

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Zaiping Jing, professor

Role: CONTACT

02131161670

References

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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.

Reference Type DERIVED
PMID: 35087876 (View on PubMed)

Other Identifiers

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https://orcid.org/0000-0002-07

Identifier Type: -

Identifier Source: org_study_id

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