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

A Multi-center Trial of Castor Single-Branched Stent Graft System for Endovascular Repair of Aortic Dissection.

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

Study Overview

• Status: Unknown
• Conditions: Distal Aortic Dissection
• Intervention / Treatment: Device: Castor Stent Graft

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zaiping JING, MD; Phone Number: 86-21-31166666; Email: jingzp@xueguan.net

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Department of Vascular Surgery, Changhai Hospital
      • Contact: Zaiping JING, MD; Phone Number: 86-21-31166666; Email: jingzp@xueguan.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Castor Stent Graft; To study the safety and efficacy of Castor single-branched stent graft system in endovascular repair of aortic dissection.	Device: Castor Stent Graft; Endovascular Repair of Aortic Dissection; Other Names: Castor Single-Branched Stent Graft System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 year stent related adverse event rate	unexpected breakage and shifting of the stent; type I or type III endoleak which needs intervention; dissection rupture around the stent	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 year success rate of treatment	complete exclusion of the dissection; no dissection rupture; no type I or type III endoleak which needs twice intervention; false lumen of aorta around stent graft closed with thrombus	1 year
1 year patency rate of branch stent	The incidence of more than 50% branch stent patency	1 year
in-hospital mortality	mortality of patients caused by dissection related postoperative complications before discharge.	participants will be followed for the duration of hospital stay, an expected average of 1 week
complication rate of neural system	complication rate of neural system related to the stent graft	2 years
1 year dissection or stent related mortality	1 year dissection or stent related mortality	1 year

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; China Medical University, China; Xijing Hospital; Peking University People's Hospital; Fudan University; Peking Union Medical College Hospital; Chinese PLA General Hospital; First Affiliated Hospital, Sun Yat-Sen University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Shandong Provincial Hospital; The First Affiliated Hospital of Zhengzhou University; Beijing Anzhen Hospital; Central South University; The Second Affiliated Hospital of Harbin Medical University; First Affiliated Hospital of Chongqing Medical University; Nanjing PLA General Hospital
• Investigators: Principal Investigator: Zaiping JING, MD, Department of Vascular Surgery, Changhai Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: July 30, 2013
• First Submitted That Met QC Criteria: August 1, 2013
• First Posted (Estimate): August 2, 2013

Study Record Updates

• Last Update Posted (Estimate): August 2, 2013
• Last Update Submitted That Met QC Criteria: August 1, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Aortic Dissection; Endovascular Repair; Single-Branched Stent Graft System
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting; Gastrointestinal Agents; Cathartics; Castor Oil
• Other Study ID Numbers: Castor-2012-04