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

Not Applicable

• Conditions: Distal Aortic Dissection
• Interventions: Device: Castor Stent Graft

• Registration Number: NCT01914237
• Lead Sponsor: Changhai Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-07-30
• Status Verified: 2013-08
• Study First Submitted QC: 2013-08-01
• Last Update Submitted: 2013-08-01
• Study First Posted: 2013-08-02
• Last Update Posted: 2013-08-02
• Primary Completion: 2015-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
success rate of endovascular repair	during the surgery	- 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.

Secondary Outcome Measures

Name	Time	Method
1 year stent related adverse event rate	1 year	* unexpected breakage and shifting of the stent; * type I or type III endoleak which needs intervention; * dissection rupture around the stent

Trial Locations

Locations (1)

Department of Vascular Surgery, Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China