NCT03767777

Prospective Study for Aortic Arch Therapy With stENt-graft for Chimney technologY（PATENCY）

Prospective Study for Aortic Arch Therapy With stENt-graft for Chimney technologY：A Prospective, Multi-center, Objective Performance Criteria Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Artery Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for the thoracic aortic dissection involving the aortic arch.

Detailed description

This clinical trial was conducted in a qualified clinical trial institution. Investigators will use Artery Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. to treat patients with thoracic aortic dissection involving the aortic arch. This is a Prospective, Multi-center, Objective Performance Criteria Clinical Trial. It is expected to submit to the ethics committee of the lead unit for review in Sep 2018, and complete the implantation of 150 patients in 18 centres nationwide within 12 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24 months postoperatively, 36 months postoperatively, 48 months postoperatively and 60 months postoperatively. This trial will evaluate whether the device reached the primary safety endpoint and primary efficacy endpoint through two primary endpoint indicators: the incidence of major adverse events (MAE) within 30 days and the success rate of aortic dissection treatment 12 months after surgery. This trail will evaluate whether the device reached the secondary safety endpoint and efficacy endpoint through several secondary endpoint indicators: 1. the incidence of all-cause death at 30 days, 6 months, 12 months and 2-5 years after surgery 2. the incidence of thoracic aortic dissection-related death at 30 days, 6 months, 12 months and 2-5 years after surgery 3. the incidence of severe adverse events (SAE) at 30 days, 6 months, 12 months and 2-5 years after surgery 4. the incidence of the device-related adverse events (AE) at 30 days, 6 months, 12 months and 2-5 years after surgery 5. the Incidence of left upper limb ischemia at 30 days, 6 months, 12 months and 2-5 years after surgery 6. the incidence of type I or type III leakage at 30 days, 6 months, 12 months after surgery 7. the incidence of graft migration at 30 days, 6 months, 12 months after surgery 8. the branching vascular patency rate at 30 days, 6 months, 12 months after surgery 9. the Incidence of Thoracic aortic dissection -related surgical conversion or re-intervention at 30 days, 6 months, 12 months and 2-5 years after surgery According to the guidelines for clinical trials of aortic stent system, the sponsor will apply for NMPA listing registration after completing a 12-month primary endpoint assessment, and annually follow-up will be conducted until the fifth year for the long-term efficacy observation.

Conditions

• Thoracic Aortic Dissection

Interventions

Type	Name	Description
DEVICE	Artery Stent Graft System	The Artery Stent Graft System consists of Ankura pro Aorta Stent Graft System along with Longuette Aortic Branch Stent Graft System for chimney technique in the aim of revascularization of aorta branches.The Ankura pro aorta stent graft and Longuette Aortic Branch Stent Graft System are pre-assembled within delivery system. During the operation, the stent graft was delivered to the target lesion location of the vascular real cavity through a delivery system, which was accurately positioned and released to isolate the ruptured opening of aortic dissection, block the continuous flow of blood into the false cavity of the dissection, and avoid further tearing or even rupture of the dissection.

Timeline

• Start date: 2019-02-01
• Primary completion: 2021-06-01
• Completion: 2025-06-01
• First posted: 2018-12-07
• Last updated: 2025-06-18

Locations

21 sites across 1 country: China