WeFlow-EndoPatch for Distal Aortic Tear Repair in Chronic Dissection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective randomized trial compares the WeFlow-EndoPatch patch to conventional care for chronic aortic dissection with distal entry tears. It plans to enroll about 204 adults across multiple centers and follow participants for up to five years, with key visits at discharge, 30 days, 6 months, 12 months, and long-term milestones. The study focuses on safety and efficacy of the patch in sealing distal tears and maintaining descending thoracic aorta dimensions. Eligible patients have specific tear characteristics and vascular access suitable for endovascular repair. The trial is sponsored by Hangzhou Endonom Medtech and conducted at Chinese PLA General Hospital in Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged 18 to 80 years old, no gender limitation;
* The patient was diagnosed with chronic aortic dissection after the repair of the main artery dissection, with distal tears required seal;
* The maximum diameter of the descending thoracic aorta is 3.5-5cm；
* The number of thoracic descending aorta tears is ≤2, and the maximum diameter of the tears is 2-30 mm；
* With appropriate artery approaches, endovascular treatment can be performed；
* 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:

* Rupture or threatened rupture of aortic dissection;
* Proximal type I internal leakage after aortic repair;
* New distal SINE;
* Abdominal aortic dissection aneurysm diameter ≥5 cm;
* The edge of the tear from the opening of celiac trunk is\<4 mm;
* The same operation requires intervention in other vascular diseases (such as coronary artery, renal artery, superior mesenteric artery, etc.);
* Acute systemic infection;
* History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
* Cardiac function Grade IV (NYHA rating) or LVEF \&lt; 30%;
* Hematological abnormalities: leukopenia (WBC \&lt; 3×10\^9/L), anemia (Hb \&lt; 90 g/L); Coagulation dysfunction, thrombocytopenia (PLT count \&lt; 50×10\^9/L);
* Renal insufficiency: serum creatinine \&gt; 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, patchs, and delivery materials;
* Pregnant or breastfeeding;
* 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 it's running

• Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Wei Guo — Chinese PLA Gencral Hosptial
• Study coordinator: Wei Guo
• Email: Pla301dml@vip.sina.com
• Phone: 13910758706

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.