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

Not Applicable

Recruiting

• Conditions: Aortic Dissection Aneurysm
• Interventions: Device: Aorta Vascular Plug System

• Registration Number: NCT06062524
• Lead Sponsor: Hangzhou Endonom Medtech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-15
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-02
• Study Start: 2023-10-24
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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:

  1. Aortic dissection aneurysm diameter ≥ 5.5cm
  2. The diameter of descending thoracic aorta dissection increased rapidly ≥5 mm/ year
  3. 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.

Exclusion Criteria

• 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;
• Life expectancy is less than 12 months (such as advanced malignant tumors);
• Investigator judged that not suitable for interventional treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WeFlow-EndoSeal Aorta Vascular Plug System	Aorta Vascular Plug System	WeFlow-EndoSeal Aorta Vascular Plug System

Primary Outcome Measures

Name	Time	Method
Aortic dissection-related mortality,	30 days, 6 months, and 12 months after operation	Refers to mortality caused by a ruptured aortic dissection or endovascular interventional treatment.
All-cause mortality	30 days, 6 months, and 12 months after operation	All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes.
No major adverse events within 30 days after operation.	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.
Serious adverse events.	30 days, 6 months, and 12 months after operation	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.
False lumen thrombosis of the descending thoracic aorta	1 month, 6 months, and 12 months after operation	False lumen thrombosis of the descending thoracic aorta (no thrombosis, partial thrombosis, complete thrombosis) observed by postoperative CTA review.
Aortic dissection progression under control	1 month, 6 months, and 12 months after operation	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.

Trial Locations

Locations (3)

The People's Hospital of Gaozhou; 🇨🇳 Gaozhou, Guangdong, China

Chinese PLA Gencral Hosptial; 🇨🇳 Beijing, Beijing, China

Zhongshan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China