NCT01914237

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Distal Aortic Dissection

Interventions

Type	Name	Description
DEVICE	Castor Stent Graft	Endovascular Repair of Aortic Dissection

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-04-01
• Completion: 2017-04-01
• First posted: 2013-08-02
• Last updated: 2013-08-02

Locations

1 site across 1 country: China