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

NCT06256757 | Not Yet Recruiting

• 1 other identifier: K2024031
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• all-cause mortality

  all-cause mortality

  1 month postoperative

Secondary Outcomes (5)

• incidence of endoleak

  postoperative (1, 6，12 months)

• incidence of secondary intervention

  postoperative (1, 6，12 months)

• incidence of major adverse events (MAE)

  postoperative (1, 6，12 months)

• immediate technical success rate

  immediate postoperative

• all-cause mortality

  postoperative (6, 12 months)

Study Arms (2)

A（extracorporeal fenestration）

EXPERIMENTAL

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

B（In situ fenestration）

SHAM COMPARATOR

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

Interventions

fenestration PROCEDURE

Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations

A（extracorporeal fenestration）; B（In situ fenestration）

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged greater than 18 years old and less than 80 years old.
• Patients diagnosed with thoracic aortic disease, including thoracic aortic dissection, thoracic aortic aneurysm, thoracic aortic ulcer and intramural hematoma.
• Patients needed endovascular repair (TEVER).
• Patients who needed complete coverage of the left subclavian artery (planned landing Zone was in Zone 2 of the aortic zone).
• 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).
• Suitable femoral artery, iliac artery and brachial artery access can be used for endovascular treatment.
• 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.
• Patients were willing to undergo follow-up evaluation as required by the study protocol.
• The life expectancy of the patient is more than 12 months.

You may not qualify if:

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

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Related Publications (1)

• 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.

  PMID: 39885531 DERIVED

MeSH Terms

Conditions

Aortic Dissection

Interventions

Fenestration, Labyrinth

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Yanbo Lou

  The Fourth Affiliated Hospital Zhejiang University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Yanbo Lou

CONTACT

15088201610; yanbo_lou@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share