Safety and Validity of Extracorporeal Fenestration and in Situ Fenestration in Patients With Aortic Disease Involving the Left Subclavian Artery

This trial aims to demonstrate the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Dissection Aneurysm
• Intervention / Treatment: Procedure: fenestration

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanbo Lou; Phone Number: 15088201610; Email: yanbo_lou@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:(All of the following criteria were met for enrolment):

1. Patients aged greater than 18 years old and less than 80 years old.
2. Patients diagnosed with thoracic aortic disease, including thoracic aortic dissection, thoracic aortic aneurysm, thoracic aortic ulcer and intramural hematoma.
3. Patients needed endovascular repair (TEVER).
4. Patients who needed complete coverage of the left subclavian artery (planned landing Zone was in Zone 2 of the aortic zone).
5. The proximal lesion involved the proximal aorta within 1.5cm of the posterior edge of the left subclavian artery (LSA) opening, but not the left common carotid artery (LCCA).
6. Suitable femoral artery, iliac artery and brachial artery access can be used for endovascular treatment.
7. The patients could understand the purpose of the study, volunteered to participate in the study, and informed consent was signed by the subjects themselves or their legal representatives.
8. Patients were willing to undergo follow-up evaluation as required by the study protocol.
9. The life expectancy of the patient is more than 12 months.

Exclusion Criteria:(If any of the following criteria is met):

1. The lesion involved the proximal aorta of the LCCA opening (Zone 0 and Zone 1).
2. The patient has a definite connective tissue disease (e.g., Marfan syndrome).
3. The subjects had a history of previous thoracic endovascular aortic repair (TEVAR).
4. Patients who have had or may have had severe allergic reactions to contrast media (anaphylactic shock, exfoliative dermatitis, etc.).
5. Patients with contraindications to antiplatelet and anticoagulant drugs.
6. The patient's compliance was poor and the follow-up could not be expected on time.
7. Patients with acute systemic infection.
8. Patients cannot tolerate general anesthesia.
9. Patients judged by the investigator to be ineligible for endovascular treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A（extracorporeal fenestration）; Based on the preoperative CTA reconstructions, the diameter of the aorta and branch vessels, lengths, angles to the arch, clock positions, and related relationships are measured, and a preoperative design for the fenestrations is developed. The outer sheath of the stent graft is then pushed back for several centimeters under sterile conditions, allowing the proximal portion of the stent graft to be released. The length of the released segment should be one to two centimeters distal from the location of fenestration. Using a sterile ruler, the location of the fenestration is determined in accordance with the preoperative plan. The 12 o'clock position is considered to be at the front of the trigger. The position of the stent graft relative to the trigger is also referred to as the 12 o'clock position. If the fenestration must avoid stent struts, then the fenestration is deemed to be at 12 o'clock, as is the position of the trigger relative to the stent graft.	Procedure: fenestration; Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations
Sham Comparator: B（In situ fenestration）; From the left brachial artery (LBA), a 6F angle-adjustable sheath (Lifetech, Inc., Shenzhen, China) is introduced retrogradely until its tip reaches the aortic stent graft. The tip is then adjusted to be as perpendicular as possible to the larger curve of the aortic stent graft. Once the sheath gets to the ideal position, a flexible needle (21 gauge, Futhrough, Lifetech, Inc.) is employed to create the fenestration in the aortic stent graft. Following the puncture, a 0.018-inch guidewire (V-18 ControlWire; Boston Scientific, Natick, MA) is inserted through the needle aperture and into the ascending aorta.	Procedure: fenestration; Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality	all-cause mortality	1 month postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of endoleak	incidence of endoleak	postoperative (1, 6，12 months)
incidence of secondary intervention	incidence of secondary intervention	postoperative (1, 6，12 months)
incidence of major adverse events (MAE)	incidence of major adverse events (MAE)	postoperative (1, 6，12 months)
immediate technical success rate	immediate technical success rate	immediate postoperative
all-cause mortality	all-cause mortality	postoperative (6, 12 months)

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Investigators: Study Director: Yanbo Lou, The Fourth Affiliated Hospital Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aneurysm; Aortic Diseases; Aortic Dissection
• Other Study ID Numbers: K2024031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Upon reasonable request, the corresponding author will provide access to the full protocol, participant level-data and statistical code

Drug and device information, study documents

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