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

NCT05186181 | Unknown

• 1 other identifier: IIT20210205B
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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

Interventions

In situ fenestration BEHAVIORAL

Interventional therapy of aortic dissection. In situ needle fenestration of left subclavian artery.

group RISEN STAR

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 19539264 BACKGROUND

• 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.

  PMID: 10332016 RESULT

• 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.

  PMID: 26211376 RESULT

• 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.

  PMID: 28867380 RESULT

• 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.

  PMID: 31200061 RESULT

MeSH Terms

Conditions

Aortic Dissection; Vascular Diseases

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• Hongkun Zhang, Doctor

  Zhejiang University

  STUDY CHAIR

Central Study Contacts

Hongkun Zhang, Doctor

CONTACT

+8687236745; 1198050@zju.edu.cn

Donglin Li, Doctor

CONTACT

+8687236745; lidonglin@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 11, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)