Triple Branched Stent Graft System for Aortic Arch Lesions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChanghai Hospital
About this trial
The goal of this clinical trial is to evaluate the safety and efficacy of the Triple Branched Covered Stent Graft System in treating aortic arch lesions. The main questions it aims to answer are:
* Does the Triple Branched Covered Stent Graft System achieve a 12-month treatment success rate that meets or exceeds the predefined target value? * What is the 30-day major adverse event (MAE) rate following the use of the Triple Branched Covered Stent Graft System?
Researchers will use a single-arm study design with predefined target values for the primary endpoints to assess the performance of the stent system.
Participants will:
* Undergo a comprehensive screening process to determine eligibility based on specific inclusion and exclusion criteria. * Receive the Triple Branched Covered Stent Graft System implantation as part of the treatment for their aortic arch lesions. * Attend follow-up visits at specified intervals (e.g., pre-discharge, 30 days post-surgery, 6 months, 12 months, and annually up to 5 years) for evaluations including imaging studies (CTA) and clinical assessments. * Report any adverse events or changes in their health status during the follow-up period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
：
Patients aged 18-80 years.
Diagnosed with aortic arch lesions that require treatment, including true aortic arch aneurysms, false aortic arch aneurysms, and aortic arch ulcers.
The investigator determines that the subject is suitable for endovascular therapy.
Disqualifiers
Pregnant or breastfeeding women.
Patients diagnosed with connective tissue diseases related to the aorta (e.g., Marfan syndrome).
Infectious aortic diseases or Takayasu arteritis.
Patients who have undergone endovascular treatment of the ascending aorta or aortic arch.
Trial design
Design model
Single group
Treatments tested in this trial
Treated with the triple branched stent graft system
DeviceParticipants treated with the triple branched stent graft system
Treatment groups
96 Participants
are divided into 1 treatment groupGroup A: Treated with the triple branched stent graft systemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
12-month Treatment Success Rate
Definition: Treatment success at 12 months is defined as immediate technical success, with no device/aneurysm-related death or unplanned secondary intervention postoperatively, and no increase in the diameter of the treated aorta segment (aneurysm or ulcer lesion diameter increased by ≥5mm) due to type I/III endoleak on CTA imaging follow-up at 12 months.
Time frame
12 months postoperatively2
30-day Major Adverse Event Rate
Any of the following events occurring within 30 days: 1.All-cause death: Any death from any cause within 30 days. 2.Disabling stroke: Defined as a Modified Rankin Scale (MRS) score ≥2 due to neurological deficits, with an increase of at least one grade from baseline. 3.Persistent paraplegia: Defined as a spinal ischemia grade ≥3 according to the spinal ischemia grading system. 4.Renal failure: New-onset persistent renal failure with a creatinine increase of more than 50% above preoperative levels, requiring dialysis. 5.Myocardial infarction: Clinically diagnosed as a new acute myocardial infarction, or requiring Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG). 6.Respiratory failure: Intubation for more than 1 week during hospitalization.
Time frame
30 days postoperativelySecondary outcomes
1
Immediate Technical Success Rate
The main and branch stents are successfully delivered to the predetermined position, accurately positioned and successfully deployed, the main and branch delivery systems are safely removed from the body, there is no branch stent stenosis or occlusion, and no device/aneurysm-related death or unplanned additional surgery.
Time frame
Immediately after the surgery2
Branch Stent Patency Rate
Based on imaging follow-up using Digital Subtraction Angiography (DSA) or Computed Tomographic Angiography (CTA), the degree of stenosis in the branches of the brachiocephalic artery, left common carotid artery, and left subclavian artery is ≤50%.
Time frame
pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively3
All-cause Mortality Rate
The rate of death from any cause postoperatively.
Time frame
pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively4
Aortic Lesion-related Mortality Rate
The rate of death related to aortic lesions.
Time frame
pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Changhai Hospital
Lead sponsor
Zhongnan Hospital
Collaborator
The University of HongKong-Shenzhen Hospital
Collaborator
West China Hospital
Collaborator
Meizhou People's Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
The Third Affiliated Hospital of Wenzhou Medical University
Collaborator
The First Affiliated Hospital of University of South China
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Guangyuan Central Hospital
Collaborator
Jining First People's Hospital
Collaborator
The First People's Hospital of Yunnan
Collaborator
Dalian Municipal Central Hospital
Collaborator
Tianjin Chest Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
The Affiliated Hospital Of Southwest Medical University
Collaborator
Kunming Yan'an Hospital
Collaborator
Source ClinicalTrials.gov
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