Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Concave Supra-arch Branched Stent-Graft System
DeviceTo evaluate the efficacy and safety of Concave Supra-arch Branched Stent-Graft System for endovascular treatment of Aortic Arch Diseases
Treatment groups
103 Participants
are divided into 1 treatment groupGroup A: Concave Supra-arch Branched Stent-Graft SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of composite endpoints
Composite endpoints refer to the occurrence of any of the following within 30 days post-surgery: all-cause mortality, disabling stroke, or permanent paraplegia.
Time frame
within 30 days post-surgery2
The clinical treatment success rate within 12 months
The 12-month clinical treatment success rate is a composite endpoint that includes immediate technical success after surgery and the absence of the following conditions at 12 months postoperatively: death, displacement of the aortic or branch covered stents on CTA follow-up, Type I or III endoleak, branch stent occlusion, and the need for secondary surgical intervention during the follow-up period.
Time frame
pre-discharge (up to 14 days) and 12 months postoperativelySecondary outcomes
1
Immediate technical success rate
Immediate technical success refers to the successful delivery of the delivery system to the predetermined position, successful deployment of the system, safe removal of the delivery system from the body, and absence of type I and III endoleaks that require intervention on angiography at the end of the procedure, with all branch stents being patent.
Time frame
Immediate intraoperative2
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.
Increase in the maximum diameter of the aneurysm/depth of ulceration\> 5 mm
Time frame
6 and 12 months postoperatively3
Incidence rate of Type I/III endoleak at Intraoperative, pre-discharge, 6 and 12 months postoperatively
A Type I endoleak occurs when there is a gap between the graft and the vessel wall at the "seal zones." This gap allows blood to flow alongside the graft into the aneurysm sac, creating pressure within the sac and increasing the risk of rupture. Type I endoleaks often occur when the aneurysm's anatomy is unsuitable for endovascular aneurysm repair (EVAR) or due to inappropriate device selection. However, vessel dilation over time can also cause this type of endoleak. Immediate attention is typically required because of the high risk of sac enlargement and rupture. A Type III endoleak results from a defect or misalignment between the components of the endograft. Similar to a Type I endoleak, a Type III endoleak causes systemic pressure within the aneurysm sac, increasing the risk of rupture. Consequently, Type III endoleaks also necessitate urgent attention. The definition of "pre-discharge" is either the discharge date or the 14th postoperative day, whichever occurs first.
Time frame
Intraoperative, pre-discharge（up to 14 days）, 6 and 12 months postoperatively4
Incidence rate of stent graft migration at 6 and 12 months postoperatively
Migration is defined according to reporting standards as a stent graft shift of more than 10 mm relative to a primary anatomic landmark, or any displacement that results in symptoms or necessitates therapy. A standardized measurement protocol was employed in accordance with the reporting guidelines.
Time frame
6 and 12 months postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Lifetech Scientific (Shenzhen) Co., Ltd.
Lead sponsor
Second Xiangya Hospital of Central South University
Collaborator
Source ClinicalTrials.gov