the Aorta Arch Stent Graft System Combined With the Endovascular Needle System in Situ Fenestration

Not Applicable

Active, not recruiting

• Conditions: Aortic Dissection
• Interventions: Device: the Aorta Arch Stent Graft System combined with the Endovascular Needle System

• Registration Number: NCT05126446
• Lead Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

Brief Summary

A prospective, multi-center, single-group target value method to evaluate the safety and effectiveness of the Aorta Arch Stent Graft System combined with the Endovascular Needle System in situ fenestration technology in the treatment of aortic dissection involving the aortic arch

Detailed Description

1. Clinical trials using prospective, multi-center, single-group target value design;

2. 120 subjects with aortic dissection requiring partial arch reconstruction will be enrolled in more than 30 centers in China, and they will meet the test enrollment requirements.

3. CTA examination was performed at baseline, 30 days, 6 months, 12 months, 36 months, and 60 months after surgery to determine the pathological status and the status of postoperative aortic and branch revascularization

Study Timeline

• Study Start: 2021-07-25
• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-08
• Study First Posted: 2021-11-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-21
• Last Update Posted: 2024-07-23
• Primary Completion: 2027-10-30
• Study Completion: 2028-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
aortic dissection involving the aortic arch	the Aorta Arch Stent Graft System combined with the Endovascular Needle System	Aortic dissection involving the aortic arch was diagnosed in patients requiring revascularization of the aortic arch and its branches

Primary Outcome Measures

Name	Time	Method
Primary safety end point of the Aorta Arch Stent Graft System: no Major Adverse events（MAE） occurrence within 30 days after surgery	Within 30 days after procedure	MAE was defined as death related to aortic dissection, ischemic stroke, and paraplegia within 30 days after surgery
Primary endpoint of the Endovascular Needle System: Immediate surgical success rate of the Endovascular Needle System	intraoperative	Intraoperative DSA, the membrane was successfully broken in situ with the membrane rupture system, and the membrane rupture system was successfully withdrawn
Primary efficacy endpoint of the Aorta Arch Stent Graft System: treatment success at 12 months after surgery	12 months after procedure	On the basis of successful surgery, the main and branch stents were unobstructed 12 months after surgery, with no internal leakage requiring intervention, no stent displacement (displacement ≤10mm), no new device-related rupture, and no device-induced aortic arch re-operation

Trial Locations

Locations (1)

Xiangya Second Hospital, Central South University; 🇨🇳 Changsha, Hunan, China