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

Thoracic Aortic Dissection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03767777
• Other study ID #: LTP84-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2020
• Source: Lifetech Scientific (Shenzhen) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: December 1, 2025
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Patients are 18 years and older, but less than 85 years old and not pregnant or lactating;

2. Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent, and are willing to complete the follow-up according to the requirements of the protocol;

3. Patients diagnosed as thoracic aortic dissection involving the arch, and the left subclavian artery branching vessel needs to be revascularized;

4. Aortic proximal landing zone =15mm;

5. Aortic proximal diameter in the range of 25-44mm;

6. The left subclavian artery distal landing zone=15mm;

7. The left subclavian artery diameter in the range of 5-18mm;

8. Patients who have eligible imported arterial vessels.

Exclusion Criteria:

1. Patients with severe stenosis, calcification in the landing area of the stent and easily lead to incomplete stent apposition;

2. Patients need intervention for other vascular diseases (such as coronary artery /renal artery) in the same surgery, or patients with heart disease and medicine treatment will be affected by the intervention;

3. Patients with a history of myocardial infraction or acute coronary syndromes in 3 months;

4. Patients with a history of cerebrovascular events or gastrointestinal bleeding in 3 months, antiplatelet agent and anticoagulant contraindication, or tendency of hemorrhage;

5. Patients have received any major surgical or interventional therapy within 30 days (Operation Classification reaches III or above) or have received interventional therapy;

6. Patients will receive any major selective operation or interventional therapy in 30days (Operation Classification reaches III or above) or will received interventional therapy;

7. Patients already treated with an thoracic aortic stent graft and the stent graft can affect operation or intersection part existing between the graft covering area;

8. Patients with genetic connective tissue disease (e.g., Marfans syndrome) or aorta hereditary disease;

9. Patients with infectious aortic dissection;

10. Patients with acute systemic infection;

11. Patients with major organ failure or other serious diseases;

12. Patients with a history of active bleeding, clotting disorder, or rejection of blood transfusions;

13. Patients with liver dysfunction: preoperative creatinine was 2.5 times higher than the normal upper limit; Alanine transaminase (ALT) or Aspartate transaminase (AST) were 5 times higher than the normal upper limit; serum total bilirubin (STB) was 2 times higher than the normal upper limit;

14. Pregnant or lactating women or women who plan to get pregnant;

15. Patients who can not tolerate to Anaesthetic;

16. Patients with a history of allergy to contrast media, stents and conveyor materials (including nickel and titanium, polyester, PTFE, and nylon polymer materials);

17. Patients with a life expectancy less than 12 months(such as terminal malignant tumor);

18. Patients who were not suitable for endovascular treatment, judged by the investigator;

19. Patients who participated in clinical trials of other drugs or medical devices at the same time.

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Thoracic Aortic Dissection

Intervention

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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospita	Beijing	Beijing
China	Fuwai hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	The First Hospital of Jilin University	Chang chun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	West China hospital of sichuan university	Chengdu	Sichuan
China	The second affiliated hospital of Harbin medical university	Harbin	Heilongjiang
China	Shandong Provincial Hospital	Jinan	Shandong
China	The first people's hospital of yunnan province	Kunming	Yunnan
China	The Frist Hospital of Lanzhou University	Lanzhou	Gansu
China	LIU ZHOU WORKER'S HOSPITAL,Fourth Affiliated Hospital of Guangxi Medical University	Liuzhou	Guangxi
China	The Second Affiliated Hospital Of Nanchang University	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital (Nanjing Gulou Yi Yuan), the Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	The first affiliated hospital of soochow university	Suzhou	Jiangsu
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	Tianjing Medical University General Hospital	Tianjin	Tianjin
China	The Central Hospital of Wuhan	Wuhan	Hubei
China	Tongji Hospital,Tongji Medical College of Huazhong University of Science&Technology	Wuhan	Hubei
China	Xijing Hospital, The Fourth Military Medical University	Xi'an	Shanxi
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The treatment success rate of aortic dissection at 12 months post-implant	Assessment of the rate of successful disease treatment defined as immediate technical success and freedom from secondary intervention at 12 months of follow-up.; Technique success means delivery system is successfully transported to the predetermined position, both of aorta stent graft and aortic branch stent graft successfully expanded and delivery system withdraw successfully.No type I/III endoleak at the end of operation, no conversion to open surgery. (Adjuvant Interventions during operation do not defined as technical failure.)	12 months after surgery
Primary	Incidence of no major adverse events (MAE) occurred at 30 days post-implant	Major Adverse events (MAE) are defined as aortic dissection related mortality, ischemic stroke, and paraplegia.	30 days after surgery
Secondary	Incidence of all-cause death		30 days,6 months, 12 months and 2-5 years after surgery
Secondary	Incidence of Aortic dissection dissection-related death		30 days,6 months, 12 months and 2-5 years after surgery
Secondary	Incidence of Serious Major Adverse Event(SAE)		30 days,6 months, 12 months and 2-5 years after surgery
Secondary	Incidence of device related adverse events(AE)		30 days,6 months, 12 months and 2-5 years after surgery
Secondary	Incidence of left upper limb ischemia		30 days,6 months, 12 months and 2-5 years after surgery
Secondary	Incidence of I/III type endoleaks		30 days,6 months, 12 months and 2-5 years after surgery
Secondary	Incidence of graft migration		30 days,6 months, 12 months and 2-5 years after surgery
Secondary	Branching vascular patency rate		30 days,6 months, 12 months and 2-5 years after surgery
Secondary	Incidence of Thoracic aortic dissection -related surgical conversion or re-intervention		30 days,6 months, 12 months and 2-5 years after surgery