Study on the Aortic Arch Single Branch Stent Graft System

Official title

Study on the Safety and Efficacy of the Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

Overview

The objective of the study is to evaluate the Safety and Efficacy of Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

Detailed description

The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee

Interventions

• Device Aortic Arch Single Branch Covered Stent System
  to Evaluate the Safety and Efficacy of the Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

Primary outcome measures

• Incidence rate for freedom from major adverse events (MAE) within 30 days postoperatively [Time frame: pre-discharge up to 14 days and 30 days post-surgery]
• Procedural success rate of aortic dissection treatment 12 months postoperatively [Time frame: intraoperative and 12 months postoperatively]

Secondary outcome measures (10)

• All-cause mortality [Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively]
• Mortality rate related to aortic dissection [Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively]
• Incidence rate of severe adverse events [Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively]
• Incidence rate of Device-related adverse events [Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively]
• The incidence rate of left upper limb ischemia [Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively]
• Incidence rate of Type I/III endoleak [Time frame: Intraoperative, pre-discharge（up to 14 days）, within 30 days and 6 and 12 months postoperatively]
• Incidence rate of stent graft migration [Time frame: 6 and 12 months postoperatively]
• The patency rate of the branch vessel [Time frame: Pre-discharge up to 14 days, 6 and 12 months postoperatively]
• The success rate of vascular remodeling for aortic dissection [Time frame: within 30 days and 6 and 12 months postoperatively]
• The incidence rate of conversion to thoracotomy or secondary interventional surgery due to aortic dissection [Time frame: Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively]

Eligibility criteria

Inclusion criteria

• Age between 18 and 80 years, gender unrestricted.
• Patients are diagnosed with Stanford Type B aortic dissection and need revascularization of the left subclavian artery.
• Anatomical criteria:

• The diameter range of the proximal aortic landing zone is 20-42 mm.
• The length of the proximal aortic landing zone (the distance from the posterior edge of the left common carotid artery orifice to the first intimal tear) is ≥15 mm.
• The distance between the left common carotid artery and the left subclavian artery is ≥5 mm.
• The length of the left subclavian artery landing zone is ≥25 mm, and the diameter range of the landing zone is 5-15 mm.
• Suitable access to the femoral artery, iliac artery, and upper limb artery.
• Patients understand the purpose of the study, volunteer to participate, and are willing to complete follow - up visits as required by the protocol.

Exclusion criteria

• Previously undergone endovascular interventional treatment involving the aortic arch, or having a history of aortic surgical repair surgery, which affects the implantation and evaluation of the single branched covered stent system of the aortic arch.
• Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area pose challenges. Such conditions may easily prevent covered stents from adhering to the vessel wall or affect stent patency.
• Infectious aortic diseases, giant cell arteritis, Marfan syndrome (or other hereditary connective tissue diseases).
• Patients with systemic or local infections that may increase the risk of infection of the endovascular graft.
• Patients who have received abdominal aortic surgical or endovascular interventional surgery within the past 3 months.
• Patients who have had a stroke attack (excluding transient ischemic attack, TIA) or myocardial infarction within the past 3 months.
• Patients known to be allergic to contrast agents, stent materials, and delivery device materials (referring to nitinol, Dacron, PTFE, nylon polymer materials).
• Patients known to have contraindications to anticoagulant and antiplatelet drugs.
• Patients intolerant to general anesthesia.
• Patients with severe abnormalities in liver, kidney, and cardiac function before the operation \[Subjects with a serum creatinine level exceeding 150 μmol/L; Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 5 times the upper limit of the normal value; Subjects with serum total bilirubin (STB) exceeding 2 times the upper limit of the normal value; Subjects with a left ventricular ejection fraction lower than 50% as indicated by echocardiography.\].
• Patients whose expected lifespan is shorter than 1 year.
• Female patients who are planning to conceive, are currently pregnant, or are breastfeeding.
• Patients whom, in the researcher's judgment, are not appropriate candidates for endovascular treatment.
• Patients who have been involved in other clinical studies and have not withdrawn from or exited the respective study groups within the three months preceding the screening period of this present 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 · 1 center

• Second Xiangya Hospital of Central South University — Changsha

Identifiers

NCT: NCT06915545 · P158CT(CN)-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗