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Prospective, multicenter, single group, observational study for the safety and efficacy of Castor stent graft and delivery system in the real world for the treatment of thoracic aortic dissection involving left subclavian artery

Prospective, multicenter, single group, observational study for the safety and efficacy of Castor stent graft and delivery system in the real world for the treatment of thoracic aortic dissection involving left subclavian artery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032900
Enrollment
Unknown
Registered
2020-05-15
Start date
2019-06-01
Completion date
Unknown
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Disease

Interventions

Case series:Castor stent implantation

Sponsors

Renji Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patient's aged >=18 years old, male or non pregnant female; 2. Patients diagnosed as aortic dissection and suitable for the use of Castor branched aortic stent graft system; 3. The proximal rupture was between 15 mm distal of left common carotid artery and 20 mm distal of left subclavian artery (LSA), or the dissection was reversed to LSA; 4. Patients can understand the purpose of the study, voluntarily participate in and sign the informed consent; 5. Patients are willing to follow up and evaluate according to the requirements of the study plan.

Exclusion criteria

Exclusion criteria: 1. The lesions involved zone 0 and zone 1; 2. The patient was definitely diagnosed as connective tissue disease (such as Marfan syndrome); 3. The patient has a clear history of allergy to nitinol alloy; 4. The patient has or may have serious allergic reaction to the contrast medium; 5. The patient's compliance is poor and the follow-up is not expected on time; 6. The life expectancy of patients is less than 12 months. (if any of the above criteria is met, it cannot be selected)

Design outcomes

Primary

MeasureTime frame
Success rate after 12 month;

Secondary

MeasureTime frame
technical successful rate;Mortality associated with aortic dissection;endoleak rate;Rate of aortic rupture;Incidence of neurological complications;Incidence of stent displacement in 6 and 12 months after operation;Incidence of branch stenosis and occlusion in 6 and 12 months after operation;Unplanned stent implantation rate during operation;Reoperation rate;Conversion rate to open surgery;30 day major adverse event (MAE) incidence;Incidence of device related adverse events;

Countries

China

Contacts

Public ContactXue Song

Department of Cardiovascular Surgery, Renji Hospital,Shanghai Jiao Tong University School of Medicine

xuesong64@163.com+86 13501754558

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026