Aortic Dissection, Distal Entry Tear
Conditions
Keywords
Aortic Dissection, Distal tear, descending aorta
Brief summary
A Multicenter, Randomized Controlled Study About the Safety and Efficacy of WeFlow-EndoPatch Aortic Endovascular Patch System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for Chronic Aortic Dissection . (GALLANT Study)
Detailed description
This study is a multicenter, prospective, superiority, randomized controlled trial about the safety and efficacy of WeFlow-EndoPatch Aortic Endovascular Patch System. It is expected to complete the implantation of 204 patients in 15 centers within 24 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24th month, 36th month, 48th month and 60th month postoperatively.
Interventions
DEVICEWeFlow-EndoPatch Aortic Endovascular Patch System
The WeFlow-EndoPatch Aortic Endovascular Patch System for aortic dissection tear is composed of a dissection tear patch system and an adjustable bend conveyor. The patch system is composed of a patch and a conveying steel cable. The patch is pre-installed on the conveying steel cable.
Doctors prescribe conventional medicines and regular imaging tests.
Sponsors
Hangzhou Endonom Medtech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 < 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, 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success Rate | 12 months | The success rate of aortic dissection treatment at 12 months is a composite index, including immediate technical success after surgery, freedom from death or aortic dissection rupture, positive aortic remodeling, and freedom from device and/or procedure related reinterventions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Entry Tears Closure Success in EndoPatch Group | 30 days, 6 months, and 12 months | Entry tears closure success is defined as absence of TL or FL backflow through the tears on CTA. |
| False Lumen Thrombosis of the Descending Thoracic Aorta | 30 days, 6 months, and 12 months | False lumen thrombosis of the descending thoracic aorta (no thrombosis, partial thrombosis, complete thrombosis) observed by postoperative CTA review. |
| True Lumen/False Lumen/Maximum Total Diameter of Descending Thoracic Aorta | 30 days, 6 months, and 12 months | True lumen diameter, false lumen diameter and maximum total diameter of the descending thoracic aorta observed by postoperative CTA review. |
| Immediate Technical Success in EndoPatch Group | Immediately after the surgery | Immediate technical success is defined as successful delivery of the endopatch conveyors to their predetermined positions, accurate positioning and successful deployment of the patch, safe removal of the delivery device outside the body, and no conversion to thoracotomy. |
| No major adverse events within 30 days after surgery | Before discharge, 30 days after surgery | Major adverse events within 30 days after surgery refer to all-cause death, aortic dissection rupture, myocardial infarction, ischemic stroke, respiratory failure, renal failure, intestinal necrosis, paraplegia, and amputation. |
| Patch Fall-off in EndoPatch Group | 30 days, 6 months, and 12 months | — |
| All-cause Mortality, Aortic Dissection-related Mortality, Serious Adverse Events, and Device-related Adverse Events | 30 days, 6 months, and 12 months | — |
| Device and/or Procedure Related Reinterventions | 30 days, 6 months, and 12 months | — |
Contacts
Primary ContactWei Guo
Outcome results
None listed