Clinical trial NCT01914237: A Multi-center Trial of Single-Branched Stent Graft System to Treat Aortic Dissection
Official title: A Multi-center Trial of Castor Single-Branched Stent Graft System for Endovascular Repair of Aortic Dissection.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Aortic Dissection
Keywords: Single-Branched Stent Graft System
Aortic Dissection
Endovascular Repair
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Fudan University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Central South University
name: Beijing Anzhen Hospital
name: Peking Union Medical College Hospital
name: Peking University People's Hospital
name: Chinese PLA General Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: The First Affiliated Hospital with Nanjing Medical University
name: Nanjing PLA General Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: Shandong Provincial Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Xijing Hospital
name: China Medical University, China
name: First Affiliated Hospital of Chongqing Medical University
First posted: 2013-08-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* age from 18 to 80, male or unpregnant female
* diagnosed as aortic dissection
* proximal tear of the dissection locates between 15mm to the distal end of left common carotid artery and 20mm to the distal end of left subclavian artery (LSA) or inverse tear to LSA
* good compliance with the instructions and cooperate with follow-up
* voluntarily signed the informed consent form

Exclusion Criteria:

* Pregnant female
* no appropriate vessel approaches
* patients with connective tissue diseases (such as Marfan syndrome)
* allergic to nitinol or contrast medium
* bad compliance with the instructions and follow-up
* estimated remaining life is less than 12 months

Primary outcomes:
measure: success rate of endovascular repair
timeFrame: during the surgery
Secondary outcomes:
measure: 1 year stent related adverse event rate
timeFrame: 1 year
Other outcomes:
measure: 1 year success rate of treatment
timeFrame: 1 year
measure: 1 year patency rate of branch stent
timeFrame: 1 year
measure: in-hospital mortality
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: complication rate of neural system
timeFrame: 2 years
measure: 1 year dissection or stent related mortality
timeFrame: 1 year
Locations:
city: Shanghai
country: China
facility: Department of Vascular Surgery, Changhai Hospital
state: Shanghai
Study officials:
affiliation: Department of Vascular Surgery, Changhai Hospital
name: Zaiping JING, MD
role: PRINCIPAL_INVESTIGATOR
References: