Guo&Amp;'s Distal Entry Tear Repair With WeFlow-EndoPatch System (Gallant Study)

Official title

Guo&Amp;'s Distal Entry Tear Repair: a Multicenter, Prospective, Superiority, Randomized Controlled Trial of the Novel WeFlow-EndoPatch Aortic Endovascular Patch System

Overview

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

• Device WeFlow-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.
• Other Conventional Treatment group
  Doctors prescribe conventional medicines and regular imaging tests.

Primary outcome measures

• Treatment Success Rate [Time frame: 12 months]

Secondary outcome measures (8)

• Immediate Technical Success in EndoPatch Group [Time frame: Immediately after the surgery]
• Entry Tears Closure Success in EndoPatch Group [Time frame: 30 days, 6 months, and 12 months]
• False Lumen Thrombosis of the Descending Thoracic Aorta [Time frame: 30 days, 6 months, and 12 months]
• True Lumen/False Lumen/Maximum Total Diameter of Descending Thoracic Aorta [Time frame: 30 days, 6 months, and 12 months]
• Device and/or Procedure Related Reinterventions [Time frame: 30 days, 6 months, and 12 months]
• No major adverse events within 30 days after surgery [Time frame: Before discharge, 30 days after surgery]
• Patch Fall-off in EndoPatch Group [Time frame: 30 days, 6 months, and 12 months]
• All-cause Mortality, Aortic Dissection-related Mortality, Serious Adverse Events, and Device-related Adverse Events [Time frame: 30 days, 6 months, and 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Erbel R, Aboyans V, Boileau C, Bossone E, Bartolomeo RD, Eggebrecht H, Evangelista A, Falk V, Frank H, Gaemperli O, Grabenwoger M, Haverich A, Iung B, Manolis AJ, Meijboom F, Nienaber CA, Roffi M, Rousseau H, Sechtem U, Sirnes PA, Allmen RS, Vrints CJ; ESC Committee for Practice Guidelines. 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: Document covering acute and chronic a PMID 25173340
• Hofferberth SC, Nixon IK, Mossop PJ. Aortic false lumen thrombosis induction by embolotherapy (AFTER) following endovascular repair of aortic dissection. J Endovasc Ther. 2012 Aug;19(4):538-45. doi: 10.1583/JEVT-12-3844R.1. PMID 22891838
• Kolbel T, Tsilimparis N, Wipper S, Larena-Avellaneda A, Diener H, Carpenter SW, Debus ES. TEVAR for chronic aortic dissection - is covering the primary entry tear enough? J Cardiovasc Surg (Torino). 2014 Aug;55(4):519-27. Epub 2014 Jun 11. PMID 24918196
• Zhu C, Huang B, Zhao J, Ma Y, Yuan D, Yang Y, Xiong F, Wang T. Influence of distal entry tears in acute type B aortic dissection after thoracic endovascular aortic repair. J Vasc Surg. 2017 Aug;66(2):375-385. doi: 10.1016/j.jvs.2016.12.142. Epub 2017 Apr 21. PMID 28438361
• Wojciechowski J, Znaniecki L, Kaszubowski M, Rogowski J. Late Aortic Remodeling after Endovascular Repair of Complicated Type B Aortic Dissection-TEVAR Protects Only the Covered Segment of Thoracic Aorta. Ann Vasc Surg. 2019 Feb;55:148-156. doi: 10.1016/j.avsg.2018.05.057. Epub 2018 Aug 4. PMID 30081168
• David TE. Adventitial inversion in the distal anastomosis in surgical treatment of acute DeBakey type I aortic dissection. J Thorac Cardiovasc Surg. 2016 May;151(5):1346-7. doi: 10.1016/j.jtcvs.2016.01.028. Epub 2016 Jan 22. No abstract available. PMID 26874601
• Nienaber CA, Yuan X, Aboukoura M, Blanke P, Jakob R, Janosi RA, Lovato L, Riambau V, Trebacz J, Trimarchi S, Zipfel B, van den Berg JC; ASSIST study group. Improved Remodeling With TEVAR and Distal Bare-Metal Stent in Acute Complicated Type B Dissection. Ann Thorac Surg. 2020 Nov;110(5):1572-1579. doi: 10.1016/j.athoracsur.2020.02.029. Epub 2020 Mar 20. PMID 32205112

Identifiers

NCT: NCT06945809 · WQ11-2402

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗