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

NCT ID: NCT06256757

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2029-04-30

Brief Summary

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.

Conditions

Aortic Dissection Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

fenestration

Intervention Type: PROCEDURE

Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations

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.

Group Type: SHAM_COMPARATOR

fenestration

Intervention Type: PROCEDURE

Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations

Interventions

fenestration

Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanbo Lou

Role: STUDY_DIRECTOR

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Central Contacts

Yanbo Lou

Role: CONTACT

yanbo_lou@zju.edu.cn

15088201610

References

Jia X, Wu J, Ding C, Lou Y. Safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery: a prospective, single-center, randomized controlled study. Trials. 2025 Jan 30;26(1):33. doi: 10.1186/s13063-025-08746-5.

Reference Type: DERIVED

PMID: 39885531 (View on PubMed)

Other Identifiers

K2024031

Identifier Type: -

Identifier Source: org_study_id