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

  • STATUS
    Recruiting
  • End date
    Dec 22, 2025
  • participants needed
    217
  • sponsor
    First Affiliated Hospital of Zhejiang University
Updated on 22 March 2022
angiography
vascular surgery
aneurysm

Summary

Background: Aortic dissection (AD) is a common emergency in vascular surgery, which seriously threatens human life and health. The rupture of Stanford type B dissection is located in aortic arch and the dissection range is from the descending aorta or involves the abdominal aorta. At present, the endovascular repair of the thoracic aorta (TEVAR) for AD has been widely deployed worldwide and has become the standard surgical procedure for the treatment of AD. However, there is still controversy regarding the Stanford B aortic dissection that involves the left subclavian artery or the stent landing area less than 1.5 cm.

Study objective: To evaluate the effectiveness and safety of endovascular repair with in situ needle fenestration of left subclavian artery.

Methods: This study intends to enroll 217 patients with Stanford type B aortic dissection who meet the enrollment criteria. The patients will be followed up at 1, 6, 12, and 24 months after endovascular repair, and the CTA images of the thoracic aorta were collected.

Details
Condition Aortic Dissection, Left Subclavian Artery Occlusion, Vascular Diseases, Interventional Therapy
Treatment In situ fenestration
Clinical Study IdentifierNCT05186181
SponsorFirst Affiliated Hospital of Zhejiang University
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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
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