Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System

NCT06062524 | Recruiting

• 1 other identifier: Endoseal V1.0
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

A prospective, single-center, first in man study to evaluate the safety and efficacy of WeFlow-EndoSeal Aorta Vascular Plug System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the dissecting aneurysm of descending thoracic aorta after aortic dissection repair.

Conditions

Aortic Dissection Aneurysm

Outcome Measures

Primary Outcomes (6)

• No major adverse events within 30 days after operation.

  Major adverse events within 30 days after operation refer to all-cause death, myocardial infarction, ischemic stroke, respiratory failure, renal failure, intestinal necrosis, paraplegia, and amputation within 30 days after operation. Among them, renal failure refers to long-lasting dialysis, kidney transplantation, or other fatal results. Intestinal necrosis is intestinal ischemia that requires bowel resection or other fatal consequences. Severe lower limb ischemia refers to new severe limp or resting pain after surgery.

  30 days after operation

• All-cause mortality

  All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes.

  30 days, 6 months, and 12 months after operation

• Aortic dissection-related mortality,

  Refers to mortality caused by a ruptured aortic dissection or endovascular interventional treatment.

  30 days, 6 months, and 12 months after operation

• Serious adverse events.

  Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.

  30 days, 6 months, and 12 months after operation

• False lumen thrombosis of the descending thoracic aorta

  False lumen thrombosis of the descending thoracic aorta (no thrombosis, partial thrombosis, complete thrombosis) observed by postoperative CTA review.

  1 month, 6 months, and 12 months after operation

• Aortic dissection progression under control

  Aortic dissection progression under control is defined as maximum increase in the diameter of false lumen diameter in descending thoracic aorta was ≤ 5 mm when compared with preoperative aortic dissection as of postoperative CTA review.

  1 month, 6 months, and 12 months after operation

Study Arms (1)

WeFlow-EndoSeal Aorta Vascular Plug System

EXPERIMENTAL

WeFlow-EndoSeal Aorta Vascular Plug System

Device: Aorta Vascular Plug System

Interventions

Aorta Vascular Plug System DEVICE

The Aorta Vascular Plug System for false lumen is composed of a vascular plug system and an adjustable bend conveyor. The plug system is composed of a patch and a conveying steel cable. The plug is pre-installed on the conveying steel cable.

WeFlow-EndoSeal Aorta Vascular Plug System

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 18 to 80 years old, no gender limitation;
• The patient was diagnosed with a dissecting aneurysm of the descending thoracic aorta after the repair of the main artery dissection, and the treatment indications were one of the following:
• Aortic dissection aneurysm diameter ≥ 5.5cm
• The diameter of descending thoracic aorta dissection increased rapidly ≥5 mm/ year
• Symptoms associated with dissection progression, such as chest and back pain
• The diameter of false lumen approximately 1 cm superiorly to the celiac trunk ≤40 mm
• Appropriate anatomical conditions were assessed by imaging to allow the adjustable bend conveyor to enter the pseudolumen through tears of the iliac artery, subrenal aorta, or renal artery levels.
• Those who can understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form by themselves or their legal representative, and are willing to complete the follow-up according to the protocol requirements.

You may not qualify if:

• Aortic rupture;
• Continuous malperfusion of internal artery branches caused by dissection;
• Had previously received false lumen embolization;
• Proximal type I endoleak after aortic repair;
• Abdominal aortic dissection aneurysm diameter \> 5 cm
• Infectious aortic disease, arteritis, Marfan syndrome (or other connective tissue diseases);
• Acute systemic infection;
• History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
• Cardiac function Grade IV (NYHA rating) or LVEF \< 30%;
• Hematological abnormalities: leukopenia (WBC \< 3×10\^9/L), anemia (Hb \< 90 g/L); Coagulation dysfunction, thrombocytopenia (PLT count \< 50×10\^9/L);
• Renal insufficiency: serum creatinine \> 150 umol/L (or 3.0 mg/dL) and/or advanced kidney disease requiring renal dialysis, as determined by the investigator after thorough analysis;
• Severe liver insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds the normal upper limit by 5 times; Serum total bilirubin (STB) exceeded the normal upper limit by 2 times;
• Allergic to contrast agents, anesthetics, plugs, and delivery materials;
• Pregnant, breastfeeding or cannot contraception during the trial period;
• Participated in clinical trials of other drugs or devices during the same period;

Sponsors & Collaborators

• Hangzhou Endonom Medtech Co., Ltd.: lead

Study Sites (3)

Chinese PLA Gencral Hosptial

Beijing, Beijing Municipality, China

RECRUITING

The People's Hospital of Gaozhou

Gaozhou, Guangdong, China

RECRUITING

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wei Guo, Professor

CONTACT

13910758706; Pla301dml@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: October 2, 2023
• Study Start: October 24, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 22, 2024

Record last verified: 2023-09

Locations

CN (3)