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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Dissection Aneurysm
• Intervention / Treatment: Device: Aorta Vascular Plug System

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Guo, Professor; Phone Number: 13910758706; Email: Pla301dml@vip.sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Chinese PLA Gencral Hosptial
      • Contact: Wei Guo; Email: Pla301dml@vip.sina.com
  • Guangdong
    • Gaozhou, Guangdong, China
      • Recruiting
      • The People's Hospital of Gaozhou
      • Contact: Yu Cao, professor
      • Principal Investigator: Yu Cao, professor
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Zhongshan Hospital Affiliated to Fudan University
      • Contact: Weiguo Fu, Professor
      • Principal Investigator: Weiguo Fu, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WeFlow-EndoSeal Aorta Vascular Plug System	Device: Aorta Vascular Plug System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hangzhou Endonom Medtech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aneurysm; Aortic Dissection
• Other Study ID Numbers: Endoseal V1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No