Endovascular repair for aortic dissection involving the left subclavian artery

Endovascular Repair of Stanford B-type Thoracic Aortic Dissection With Insufficient Proximal Landing Zone by Left Subclavian Artery in Situ Stent Graft Puncture and Fenestration: A Prospective, Single-arm, Observational Clinical Trial.

This study is testing a new way to fix a specific type of aortic dissection that affects the left subclavian artery to see if it is safe and effective for patients.

Quick facts

• Study type: Observational
• Enrollment: 217 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05186181 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of a novel endovascular repair technique using in situ needle fenestration for patients with Stanford type B aortic dissection that involves the left subclavian artery. The trial aims to enroll 217 patients who meet specific criteria, including the proximity of the dissection to the left subclavian artery and the characteristics of the landing area for the stent. Participants will be monitored through follow-up assessments at 1, 6, 12, and 24 months post-procedure to evaluate outcomes and complications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 diagnosed with Stanford type B aortic dissection near the left subclavian artery.

Not a fit: Patients with congenital connective tissue diseases or those who have undergone previous ascending aorta surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with complex aortic dissections involving the left subclavian artery.

How similar studies have performed: While endovascular repair techniques have been widely used, this specific approach of in situ needle fenestration is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Hongkun Zhang, Doctor

Conditions Aortic Dissection; Left Subclavian Artery Occlusion; Vascular Diseases; Interventional Therapy