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

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Status: Not yet enrolling

Conditions: Aortic Dissection Aneurysm

Treatments: Procedure: fenestration

Study type: Interventional

Funder types: Other

Identifiers

NCT06256757

K2024031

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

A（extracorporeal fenestration）

Experimental group

Description:

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.

Treatment:

Procedure: fenestration

B（In situ fenestration）

Sham Comparator group

Description:

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.

Treatment:

Procedure: fenestration