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

Overview

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.

Interventions

• Device Concave Supra-arch Branched Stent-Graft System
  To evaluate the efficacy and safety of Concave Supra-arch Branched Stent-Graft System for endovascular treatment of Aortic Arch Diseases

Primary outcome measures

• Incidence of composite endpoints [Time frame: within 30 days post-surgery]
• The clinical treatment success rate within 12 months [Time frame: pre-discharge (up to 14 days) and 12 months postoperatively]

Secondary outcome measures (12)

• Immediate technical success rate [Time frame: Immediate intraoperative]
• 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. [Time frame: 6 and 12 months postoperatively]
• Incidence rate of Type I/III endoleak at Intraoperative, pre-discharge, 6 and 12 months postoperatively [Time frame: Intraoperative, pre-discharge（up to 14 days）, 6 and 12 months postoperatively]
• Incidence rate of stent graft migration at 6 and 12 months postoperatively [Time frame: 6 and 12 months postoperatively]
• The patency rate of the branch vessel at 6 and 12 months postoperatively [Time frame: 6 and 12 months postoperatively]
• 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 [Time frame: before discharge （up to 14 days）, at the 6 months and 12 months , and at 2-5 years postoperative]
• Incidence rate of aneurysm rupture at Intraoperative, pre-discharge, 6 and 12 months, 2-5 years postoperatively [Time frame: Intraoperative, pre-discharge (up to 14 days）, 6 and 12 months 2-5 years postoperatively]
• Incidence rate of delivery system-related complications during perioperative period (from surgery to 30 days after surgery) [Time frame: perioperative period (from surgery to 30 days after surgery)]
• Incidence rate of MAE at Intraoperative, pre-discharge and within 30 days postoperatively [Time frame: Intraoperative, pre-discharge（up to 14 days） and within 30 days postoperatively]
• All-cause mortality at 6 months, 12 months, and 2-5 years postoperatively [Time frame: 6 months, 12 months, and 2-5 years postoperatively]
• Aortic-related mortality at 6 months, 12 months, and 2-5 years postoperatively [Time frame: 6 months, 12 months, and 2-5 years postoperatively]
• Incidence rate of severe adverse events at 6 months, 12 months, and 2-5 years postoperatively [Time frame: 6 months, 12 months, and 2-5 years postoperatively]

Eligibility criteria

Inclusion criteria

• Patients who are aged 18 to 80 years inclusive；
• 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;
• Anatomical criteria, including:

• Ascending aorta length is greater than or equal to 50 mm (distance from aortic sinus to anterior edge of innominate artery);
• 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;
• 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;
• 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;
• Have a suitable iliac, femoral, and superior arch arterial access;
• 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.;
• 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

• Patients either with ruptured or infected aneurysms;
• Patients with aortic dissection;
• Patients with general or local infections that may increase the risk of endovascular graft infection;
• 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;
• Previous endovascular intervention involving the aortic arch;
• Underwent open or endovascular surgery for abdominal aorta within the past 3 months;
• Patients with a history of stroke within the past 3 months (excluding TIA);
• Patients with aneurysms involving the distal descending aorta and requiring reconstruction of important visceral branch vessels within the abdomen;
• Patients with a history of myocardial infarction within the past 3 months;
• Patients with congestive heart failure - NYHA Class IV;
• Patients allergic to contrast agents, stent and delivery system materials (such as nitinol, polyester, PTFE, nylon polymer materials);
• Patients with contraindications to anticoagulant or antiplatelet drugs;
• Patients unable to tolerate general anesthesia;
• 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);
• Patients with connective tissue diseases, such as Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease;
• Patients with arteritis;
• Patients with a life expectancy of less than 1 year;
• Women who are planning to conceive, pregnant or breastfeeding;
• Patients deemed by the investigator as unsuitable for endovascular treatment;
• 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.

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

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

China · 16 centers

• Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing
• Second Xiangya Hospital of Central South University — Changsha
• West China Hospital, Sichuan University — Chengdu
• The First Affiliated Hospital of Fujian Medical University — Fuzhou
• Union Hospital Affiliated to Fujian Medical University — Fuzhou
• The First Affiliated Hospital of Zhejiang University School of Medicine — Hanzhou
• The First Affiliated Hospital of Kunming Medical University — Kunming
• The First People's Hospital of Yunnan Province — Kunming
• … and 8 more centers

Germany · 1 center

• Universitäts-Herzzentrum Freiburg - Bad Krozingen — Freiburg im Breisgau

Identifiers

NCT: NCT06520774 · P134-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗