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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Diseases; Aortic Dissection; Interventional Therapy; Left Subclavian Artery Occlusion
• Intervention / Treatment: Behavioral: In situ fenestration

• Study Type: Observational
• Enrollment (Anticipated): 217

Contacts and Locations

• Study Contact: Name: Hongkun Zhang, Doctor; Phone Number: +8687236745; Email: 1198050@zju.edu.cn
• Study Contact Backup: Name: Donglin Li, Doctor; Phone Number: +8687236745; Email: lidonglin@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Donglin Li, Doctor; Phone Number: +8687236745; Email: lidonglin@zju.edu.cn
      • Contact: Tianchi Chen, Doctor; Phone Number: +8687236745; Email: tianchichen@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Stanford B-type aortic dissection, the proximal landing area is less than 15mm, and the left subclavian artery needs to be reconstructed.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group RISEN STAR; Patients with Stanford B-type aortic dissection will be treated with endovascular repair with in situ needle fenestration of left subclavian artery.	Behavioral: In situ fenestration; Interventional therapy of aortic dissection. In situ needle fenestration of left subclavian artery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patency rate of main and branch stent.	Patency of main and branch stent will be evaluated by Computed Tomography Angiography.	1 month after interventional therapy.
Patency rate of main and branch stent.	Patency of main and branch stent will be evaluated by Computed Tomography Angiography.	6 months after interventional therapy.
Patency rate of main and branch stent.	Patency of main and branch stent will be evaluated by Computed Tomography Angiography.	12 months after interventional therapy
Patency rate of main and branch stent.	Patency of main and branch stent will be evaluated by Computed Tomography Angiography.	24 months after interventional therapy

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Investigators: Study Chair: Hongkun Zhang, Doctor, Zhejiang University

Publications and helpful links

General Publications

• Eggebrecht H, Mehta RH, Dechene A, Tsagakis K, Kuhl H, Huptas S, Gerken G, Jakob HG, Erbel R. Aortoesophageal fistula after thoracic aortic stent-graft placement: a rare but catastrophic complication of a novel emerging technique. JACC Cardiovasc Interv. 2009 Jun;2(6):570-6. doi: 10.1016/j.jcin.2009.03.010.
• Dake MD, Kato N, Mitchell RS, Semba CP, Razavi MK, Shimono T, Hirano T, Takeda K, Yada I, Miller DC. Endovascular stent-graft placement for the treatment of acute aortic dissection. N Engl J Med. 1999 May 20;340(20):1546-52. doi: 10.1056/NEJM199905203402004.
• Cambria RP, Conrad MF, Matsumoto AH, Fillinger M, Pochettino A, Carvalho S, Patel V, Matsumura J. Multicenter clinical trial of the conformable stent graft for the treatment of acute, complicated type B dissection. J Vasc Surg. 2015 Aug;62(2):271-8. doi: 10.1016/j.jvs.2015.03.026.
• Canaud L, Morishita K, Gandet T, Sfeir J, Bommart S, Alric P, Mandelli M. Homemade fenestrated stent-graft for thoracic endovascular aortic repair of zone 2 aortic lesions. J Thorac Cardiovasc Surg. 2018 Feb;155(2):488-493. doi: 10.1016/j.jtcvs.2017.07.045. Epub 2017 Aug 5.
• Xiang Y, Qiu C, He Y, Li D, Shang T, Wu Z, Zhang H. A Single Center Experience of In Situ Needle Fenestration of Supra-aortic Branches During Thoracic Endovascular Aortic Repair. Ann Vasc Surg. 2019 Nov;61:107-115. doi: 10.1016/j.avsg.2019.03.016. Epub 2019 Jun 11.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Aneurysm; Vascular Diseases; Aneurysm, Dissecting
• Other Study ID Numbers: IIT20210205B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No