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Evaluation of the Castor Single Branch Stent Graft in Treatment of Acute Aortic Syndrome

NCT ID: NCT05965453

Last Updated: 2023-07-28

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

RECRUITING

Total Enrollment

205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2032-06-01

Brief Summary

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The objective of this study to evaluate the safety and effectiveness of the Castor single branch stent graft for endovascular repair of acute aortic syndrome patients without an inadequate proximal landing zone (\<15mm)

Detailed Description

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The goal of this observational, ambispective, and multicenter cohort study is to evaluate efficacy and safety of the Castor single branch stent graft.

205 patients who received thoracic endovascular aortic repair by meant of the Castor single branch stent graft from June 2018 to June 2022 were enrolled in our study. All enrolled patients have an inadequate proximal landing zone (\<15mm) , and they underwent routine follow-up after thoracic endovascular aortic repair at 1-month, 6-months, and 1-year for the following, but not limited to assessment: physical examination, laboratory test and the CT angiography.

Meanwhile, the enrolled patients will come for continuous follow-up at 2-years, 3-years, and annually to 10-years post-procedure.

Conditions

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Acute Aortic Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Participants received thoracic endovascular aortic repair with Castor single branch stent graft

Participants who have an inadequate proximal landing zone received thoracic endovascular aortic repair by meant of the Castor single branch stent graft

the Castor single branch stent graft

Intervention Type DEVICE

Participants who received thoracic endovascular aortic repair by meant of the Castor single branch stent graft from June 2018 to June 2022 were enrolled in our study.

Interventions

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the Castor single branch stent graft

Participants who received thoracic endovascular aortic repair by meant of the Castor single branch stent graft from June 2018 to June 2022 were enrolled in our study.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with acute Stanford type B aortic syndrome who received thoracic endovascular aortic repair by meant of Castor single branch stent graft from June 2018 to June 2022

Exclusion Criteria

* Patients with acute type B aortic syndrome with an adequate proximal landing zone (≥15mm)
* Previous endovascular repair of the aorta
* Patients with missing data and loss of follow-up
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanzhong Central Hospital

OTHER

Sponsor Role collaborator

Affiliated Hospital of Gansu Medical College

UNKNOWN

Sponsor Role collaborator

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Xianyang Hospital of Yan'an University

UNKNOWN

Sponsor Role collaborator

Baoji Central Hospital

OTHER

Sponsor Role collaborator

General Hospital of Ningxia Medical University

OTHER

Sponsor Role collaborator

People's Hospital of Ningxia Hui Autonomous Region

OTHER

Sponsor Role collaborator

Qinghai Red Cross Hospital

OTHER

Sponsor Role collaborator

Hanzhong People's Hospital

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongyan Tian, MD

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Locations

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First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongyan Tian, MD

Role: CONTACT

Phone: 0086-13891981101

Email: [email protected]

Mengyang Kang, MD

Role: CONTACT

Phone: 0086-18717366324

Email: [email protected]

Facility Contacts

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Hongyan Tian

Role: primary

Other Identifiers

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No.XJTU1AF2023LSK-148

Identifier Type: -

Identifier Source: org_study_id