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

NCT01914237 | Unknown

• 1 other identifier: Castor-2012-04
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 year success rate of treatment
• 1 year patency rate of branch stent
• safety:
• in-hospital mortality
• complication rate of neural system
• 1 year dissection or stent related mortality

Conditions

Distal Aortic Dissection

Keywords

Single-Branched Stent Graft System; Aortic Dissection; Endovascular Repair

Outcome Measures

Primary Outcomes (1)

• success rate of endovascular repair

  \- during the surgery: successful conduction, accurate positioning and release, and no warping, folding, narrowing or blocking of the stent graft system. Immediately after the stent release, angiography shows both main stent and side arm stent patency, successful exclusion of dissection and no arteriorrhexis or dissection rupture.

  during the surgery

Secondary Outcomes (1)

• 1 year stent related adverse event rate

  1 year

Other Outcomes (5)

• 1 year success rate of treatment

  1 year

• 1 year patency rate of branch stent

  1 year

• in-hospital mortality

  participants will be followed for the duration of hospital stay, an expected average of 1 week

Study Arms (1)

Castor Stent Graft

EXPERIMENTAL

To study the safety and efficacy of Castor single-branched stent graft system in endovascular repair of aortic dissection.

Device: Castor Stent Graft

Interventions

Castor Stent Graft DEVICE

Endovascular Repair of Aortic Dissection

Also known as: Castor Single-Branched Stent Graft System

Castor Stent Graft

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead
• Fudan University: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Central South University: collaborator
• Beijing Anzhen Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• Peking University People's Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Nanjing PLA General Hospital: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Shandong Provincial Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Xijing Hospital: collaborator
• China Medical University, China: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (1)

Department of Vascular Surgery, Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

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

Study Officials

• Zaiping JING, MD

  Department of Vascular Surgery, Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zaiping JING, MD

CONTACT

86-21-31166666; jingzp@xueguan.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Vascular Surgery

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 2, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2017
• Last Updated: August 2, 2013

Record last verified: 2013-08

Locations

CN (1)