Endovascular Repair With In Situ nEedle feNestration of Left Subclavian Artery to Treat AoRtic Dissection(RISEN STAR):A Multicenter Prospective Trial.

Launched by FIRST AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY · Jan 6, 2022

Keywords

ClinConnect Summary

The RISEN STAR clinical trial is studying a new way to treat a serious condition called aortic dissection, specifically when it involves the left subclavian artery. Aortic dissection is when the inner layer of the aorta tears, which can be life-threatening. The trial aims to see if a special technique called "in situ needle fenestration" can safely and effectively repair the left subclavian artery during endovascular repair. This procedure is designed for patients diagnosed with Stanford type B aortic dissection, where the dissection is close to the left subclavian artery, and who meet specific health criteria.

To participate in this trial, individuals should be between 18 and 85 years old and must have a confirmed diagnosis of Stanford type B aortic dissection. They should also have a specific type of blood vessel structure near the left subclavian artery. Participants will undergo the endovascular repair procedure and will be monitored for up to two years with follow-up visits at 1, 6, 12, and 24 months. This study is currently recruiting patients, and all participants will need to provide informed consent before joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Based on Computed Tomography Angiography, it is clearly diagnosed as Stanford B type aortic dissection with a breach close to the left subclavian artery;
• • The dissection the left subclavian artery, and the proximal landing area is less than 1.5cm. The proximal end of the stent needs to be anchored in zone 2 and the left subclavian needs to be performed arterial revascularization;
• • Landing area requirements: no dissection, no intermural hematoma, no severe calcification, no aneurysm-like expansion, diameter 21-44mm, distance between left common carotid artery and left subclavian artery≥10mm;
• • The puncture in situ fenestration technique was used to reconstruct the left subclavian artery;
• • Signed informed consent;
• • Age ≥18 years old, ≤85 years old, no gender limit.
• Exclusion Criteria:
• • Combined ascending aorta disease or performed ascending aorta surgery before;
• • Congenital connective tissue disease (Marfan syndrome, etc.);
• • Patients with renal failure or chronic kidney disease before endovascular repair(eGFR≤30ml/min, Dialysis needed, serum creatinine ≥2.5mg/mL within 30 days before operation);
• • Cerebral hemorrhage, symptomatic cerebral infarction within 6 weeks before treatment, myocardial infarction within 6 weeks before treatment;
• • Combined systemic diseases that cannot be controlled by current medical level (Such as severe heart function, lung function or liver function abnormalities, patients with advanced tumors, patients with cachexia, severe coronary heart disease symptoms that cannot be relieved, abnormal blood coagulation caused by genetic diseases, etc.) ；
• • Patient under 18 years or older than 85 years;
• • The life expectancy of the patient is shorter than 2 years;
• • Those suffering from mental illness or subjectively unable to cooperate;
• • Women who are breastfeeding or pregnant, or women or men who have recently had a childbirth plan;
• • Currently participating in other interventions research or patients who have been enrolled in this study;
• • Have a history of aortic or left subclavian artery surgery;
• • Active systemic infection or uncontrolled coagulation dysfunction within 14 days before treatment;
• • Those who are unable to take the medication as required by the protocol, or are allergic to antiplatelet drugs (aspirin or clopidogrel), low molecular weight heparin or contrast agents;
• • Type II heparin-induced thrombocytopenia (HIT-2) or known hypersensitivity to heparin;
• • Thoracic aortic aneurysm, pseudoaneurysm, simple thoracic aortic transmural ulcer, thoracic aortic intermural hematoma;
• • There are prominent or irregular thrombus and/or atheroma in the aortic arch or ascending aorta;
• • The iliac artery or femoral artery approach is severely diseased and the stent cannot be passed;
• • The left subclavian artery is occluded or left Those who have no suitable access for the upper extremities;
• • The left subclavian artery is abnormally twisted or angled and is not suitable for fenestration;
• • Other conditions that the investigator judges are not suitable for enrollment.