Safety and efficacy of coil-stent system for sealing distal entry tears of aortic dissection

Phase 1

Completed

• Conditions: distal entry tears of aortic dissection

• Registration Number: ChiCTR2400088751
• Lead Sponsor: Shanghai Changhai Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Non-pregnant subjects aged 18 to 85 years old;<br>Patients diagnosed with distal aortic dissection requiring endovascular treatment (the proximal tear of the aortic dissection has been treated, but there is still a dissection tear in the distal descending thoracic aorta and beyond and accompanied by any one or more of the following conditions: patients with distal dissection on the verge of rupture, poor perfusion of branch arteries, dissection-related pain, the maximum diameter of the aorta in the area affected by dissection >50mm, or patients with continued expansion of the dissection false lumen during follow-up));<br>Subjects judged by the investigator to be suitable for endovascular treatment;<br>Subjects who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to follow up;<br>Anatomical conditions: the diameter of the thoracoabdominal aorta is =14mm and =32mm; the number of distal tears is greater than or equal to 2, and the diameter of the tears is =20mm.

Exclusion Criteria

Women who are pregnant or breastfeeding;<br>The patient was clearly diagnosed with aorta-related connective tissue disease (such as Marfan syndrome, etc.);<br>The patient has a clear history of allergies to nickel-titanium alloy, platinum-tungsten alloy, contrast media, etc.;<br>Severe liver function abnormalities (alanine aminotransferase or aspartate aminotransferase 2.5 times higher than the upper limit of normal);<br>Hematological abnormalities: leukopenia (WBC<3×10^9/L), acute anemia (Hb<90g/L), thrombocytopenia (PLT<50×10^9/L), history of bleeding or coagulation disorder;<br>Myocardial infarction or stroke in the past month;<br>Cardiac function class IV (NYHA classification);<br>Uncontrolled infection, such as bacteremia or toxemia;<br>Patients who have malignant tumors with life expectancy less than 12 months;<br>The subject is participating in other clinical trials of drugs or medical devices and has not yet completed the primary endpoint of the study;<br>Patients with poor compliance and unable to follow up as planned;<br>Other situations determined by the investigator to be inappropriate for endovascular treatment, such as the lack of suitable vascular access or the inability of the subject to cooperate, etc.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of 30-day major adverse event;

Secondary Outcome Measures

Name	Time	Method
instant technical success rate;instant surgical success rate;clinical success rate(6-month,12-month);Aortic false lumen thrombosis(30-day, 6-month, 12-month);all-cause mortality;aortic dissection-related mortality;incidence of neurological complication;incidence of secondary intervention;aortic dissection maximum diameter and maximum diameter changes;incidence of major adverse event(6-month, 12-month);