A Multi-center Trial of Single-Branched Stent Graft System to Treat Aortic Dissection

Summary

Aim:Castor is a novel single-branched stent graft system for endovascular repair of aortic arch dissection. This is a prospective, one-arm, open, multi-center, pre-market study of Castor stent to evaluate its efficacy and safety in treatment of aortic dissection.

Number of patients: 70 patients will be included and undertaken endovascular repair with Castor stent.

Follow-up: 1.aortic computed tomographic angiography (CTA) examination 6 and 12 months after the surgery 2.telephone or clinical follow-up 30 days and 2-5 years after the surgery

Primary Outcome Measure: success rate of endovascular repair for efficacy measurement.

Secondary Outcome Measure: 1 year stent related adverse event rate for safety measurement.

Other Outcome Measures:

1. efficacy:

* 1 year success rate of treatment
* 1 year patency rate of branch stent
2. safety:

* in-hospital mortality
* complication rate of neural system
* 1 year dissection or stent related mortality

Conditions

• Distal Aortic Dissection

Interventions

DEVICE

Castor Stent Graft

Endovascular Repair of Aortic Dissection

Sponsors & Collaborators

• Fudan University

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• Central South University

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Nanjing PLA General Hospital

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Xijing Hospital

  collaborator OTHER

• China Medical University, China

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Changhai Hospital

  lead OTHER

Principal Investigators

• Zaiping JING, MD · Department of Vascular Surgery, Changhai Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2015-04-30

Completion

2017-04-30

Countries

• China

Study Locations