Evaluating a new vascular plug system for aortic dissection aneurysms

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

This study is testing a new device to see if it can safely and effectively help people with a specific type of aneurysm after surgery for aortic dissection.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Hangzhou Endonom Medtech Co., Ltd. (Industry-sponsored)
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT06062524 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, single-center evaluation of the WeFlow-EndoSeal Aorta Vascular Plug System, designed specifically for patients with dissecting aneurysms of the descending thoracic aorta following aortic dissection repair. The study aims to assess both the safety and efficacy of this innovative device in managing aortic dissection complications. Eligible participants will be those diagnosed with specific criteria related to the size and progression of their aneurysms. The trial will involve careful imaging assessments to ensure appropriate anatomical conditions for the intervention.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 18 to 80 with a diagnosed dissecting aneurysm of the descending thoracic aorta that meets specific size and progression criteria.

Not a fit: Patients with smaller aneurysms or those not meeting the anatomical and symptomatic criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from aortic dissection aneurysms, potentially improving their outcomes and quality of life.

How similar studies have performed: While this approach is novel, similar studies evaluating vascular plug systems for aortic conditions have shown promise, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 2 other locations

• 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)

Study contacts

• Study coordinator: Wei Guo, Professor

Conditions Aortic Dissection Aneurysm