Clinical trial NCT06520774: Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
Official title: A Prospective, Multicenter, Single-Group Target-Value Clinical Trial: Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Arch Aneurysm
Penetrating Aortic Ulcer
Keywords: Lifetech
Concave Supra-arch Branched Stent-Graft System
Endovascular Treatment
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Second Xiangya Hospital of Central South University
First posted: 2024-07-25
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of the study is to evaluate the safety and efficacy of the Lifetech Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases

Detailed description: The physician must strictly adhere to the clinical study protocol and shall not deviate from or substantially alter it. However, in cases of emergency where there is an immediate risk to the subjects that must be eliminated immediately, a report may be submitted in written form afterward. During the study, any amendments to the clinical study protocol, informed consent documents, requests for deviation, and the resumption of a suspended clinical study must receive written approval from the Ethics Committee.

Eligibility criteria: Inclusion Criteria:

1. Patients who are aged 18 to 80 years inclusive；
2. Patients diagnosed with aortic arch aneurysms or penetrating ulcers that require intervention, and for whom the proximal end of the stent needs to be anchored in the Z0 zone;
3. Anatomical criteria, including:

   1. Ascending aorta length is greater than or equal to 50 mm (distance from aortic sinus to anterior edge of innominate artery);
   2. The diameter range of the anchoring area at the proximal end of the main body is between 25-45 mm and the length is greater than or equal to 30 mm;
   3. The diameter of the anchored area of supra-arch branch vessels (innominate artery, left common carotid artery, left subclavian artery) is between 5-18 mm, distal anchorage length is greater than or equal to 15 mm;
   4. Distance between the anterior edge of the innominate artery to the posterior edge of the left subclavian artery is less than or equal to 80 mm;
   5. Have a suitable iliac, femoral, and superior arch arterial access;
4. At least two researchers should assess that the subject is a high-risk patient for surgical treatment or has significant contraindications to surgery. It is recommended to refer to the following criteria: a score of ≥6 in the European System for Cardiac Operative Risk Evaluation (EuroSCORE) scoring system.;
5. Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up visits as required by the protocol.

Exclusion Criteria:

1. Patients either with ruptured or infected aneurysms;
2. Patients with aortic dissection;
3. Patients with general or local infections that may increase the risk of endovascular graft infection;
4. Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area, which is likely to impede stent-graft adherence or affect stent patency;
5. Previous endovascular intervention involving the aortic arch;
6. Underwent open or endovascular surgery for abdominal aorta within the past 3 months;
7. Patients with a history of stroke within the past 3 months (excluding TIA);
8. Patients with aneurysms involving the distal descending aorta and requiring reconstruction of important visceral branch vessels within the abdomen;
9. Patients with a history of myocardial infarction within the past 3 months;
10. Patients with congestive heart failure - NYHA Class IV;
11. Patients allergic to contrast agents, stent and delivery system materials (such as nitinol, polyester, PTFE, nylon polymer materials);
12. Patients with contraindications to anticoagulant or antiplatelet drugs;
13. Patients unable to tolerate general anesthesia;
14. Patients with abnormal liver and kidney function before surgery (ALT or AST more than 5 times the upper limit of normal; serum creatinine (Cr) \>150umol/L);
15. Patients with connective tissue diseases, such as Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease;
16. Patients with arteritis;
17. Patients with a life expectancy of less than 1 year;
18. Women who are planning to conceive, pregnant or breastfeeding;
19. Patients deemed by the investigator as unsuitable for endovascular treatment;
20. Patients who have participated in other clinical studies and have not withdrawn or been excluded within the 3 months prior to the screening period of this study.

Primary outcomes:
measure: Incidence of composite endpoints
timeFrame: within 30 days post-surgery
measure: The clinical treatment success rate within 12 months
timeFrame: pre-discharge (up to 14 days) and 12 months postoperatively
Secondary outcomes:
measure: Immediate technical success rate
timeFrame: Immediate intraoperative
measure: Incidence of increase in the maximum diameter of the aneurysm/depth of ulceration by more than 5 mm at 6 months and 12 months postoperatively.
timeFrame: 6 and 12 months postoperatively
measure: Incidence rate of Type I/III endoleak at Intraoperative, pre-discharge, 6 and 12 months postoperatively
timeFrame: Intraoperative, pre-discharge（up to 14 days）, 6 and 12 months postoperatively
measure: Incidence rate of stent graft migration at 6 and 12 months postoperatively
timeFrame: 6 and 12 months postoperatively
measure: The patency rate of the branch vessel at 6 and 12 months postoperatively
timeFrame: 6 and 12 months postoperatively
measure: Incidence rate of secondary surgical interventions related to the aortic arch and its branch arteries before discharge , at the 6 months and 12 months , and at 2-5 years postoperatively
timeFrame: before discharge （up to 14 days）, at the 6 months and 12 months , and at 2-5 years postoperative
measure: Incidence rate of aneurysm rupture at Intraoperative, pre-discharge, 6 and 12 months, 2-5 years postoperatively
timeFrame: Intraoperative, pre-discharge (up to 14 days）, 6 and 12 months 2-5 years postoperatively
measure: Incidence rate of delivery system-related complications during perioperative period (from surgery to 30 days after surgery)
timeFrame: perioperative period (from surgery to 30 days after surgery)
measure: Incidence rate of MAE at Intraoperative, pre-discharge and within 30 days postoperatively
timeFrame: Intraoperative, pre-discharge（up to 14 days） and within 30 days postoperatively
measure: All-cause mortality at 6 months, 12 months, and 2-5 years postoperatively
timeFrame: 6 months, 12 months, and 2-5 years postoperatively
measure: Aortic-related mortality at 6 months, 12 months, and 2-5 years postoperatively
timeFrame: 6 months, 12 months, and 2-5 years postoperatively
measure: Incidence rate of severe adverse events at 6 months, 12 months, and 2-5 years postoperatively
timeFrame: 6 months, 12 months, and 2-5 years postoperatively
measure: Incidence rate of Device-related adverse events at 6 months, 12 months, and 2-5 years postoperatively
timeFrame: 6 months, 12 months, and 2-5 years postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Peking
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: chang shu, Professor
role: PRINCIPAL_INVESTIGATOR
References: