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

Naval Military Medical University

Status: Unknown

Conditions: Distal Aortic Dissection

Treatments: Device: Castor Stent Graft

Study type: Interventional

Funder types: Other

Identifiers

NCT01914237

Castor-2012-04

Details and patient eligibility

About

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

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

70 participants in 1 patient group

Castor Stent Graft

Experimental group

Description:

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

Treatment:

Device: Castor Stent Graft