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

Distal Aortic Dissection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01914237
• Other study ID #: Castor-2012-04
• Status: Recruiting
• Phase: N/A
• First received: July 30, 2013
• Last updated: August 1, 2013
• Start date: April 2013
• Est. completion date: April 2017

Study information

• Verified date: August 2013
• Source: Changhai Hospital
• Contact: Zaiping JING, MD
• Phone: 86-21-31166666
• Email: jingzp[@]xueguan.net
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distal Aortic Dissection

Intervention

Device:
• Castor Stent Graft
Endovascular Repair of Aortic Dissection

Locations

Country	Name	City	State
China	Department of Vascular Surgery, Changhai Hospital	Shanghai	Shanghai

Sponsors (17)

Lead Sponsor

Collaborator

Changhai Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	1 year patency rate of branch stent	The incidence of more than 50% branch stent patency	1 year	No
Other	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	Yes
Other	complication rate of neural system	complication rate of neural system related to the stent graft	2 years	Yes
Other	1 year dissection or stent related mortality	1 year dissection or stent related mortality	1 year	Yes
Primary	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	No
Secondary	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	Yes