Clinical trial NCT03767777: Prospective Study for Aortic Arch Therapy With stENt-graft for Chimney technologY（PATENCY）
Official title: Prospective Study for Aortic Arch Therapy With stENt-graft for Chimney technologY：A Prospective, Multi-center, Objective Performance Criteria Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Aortic Dissection
Keywords: Aortic arch
Aortic disease
Aortic Dissection
Stent Graft
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The treatment success rate of aortic dissection at 12 months post-implant
timeFrame: 12 months after surgery
measure: Incidence of no major adverse events (MAE) occurred at 30 days post-implant
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Incidence of all-cause death
timeFrame: 30 days，6 months, 12 months and 2-5 years after surgery
measure: Incidence of Aortic dissection dissection-related death
timeFrame: 30 days，6 months, 12 months and 2-5 years after surgery
measure: Incidence of Serious Major Adverse Event（SAE）
timeFrame: 30 days，6 months, 12 months and 2-5 years after surgery
measure: Incidence of device related adverse events（AE）
timeFrame: 30 days，6 months, 12 months and 2-5 years after surgery
measure: Incidence of left upper limb ischemia
timeFrame: 30 days，6 months, 12 months and 2-5 years after surgery
measure: Incidence of I/III type endoleaks
timeFrame: 30 days，6 months, 12 months and 2-5 years after surgery
measure: Incidence of graft migration
timeFrame: 30 days，6 months, 12 months and 2-5 years after surgery
measure: Branching vascular patency rate
timeFrame: 30 days，6 months, 12 months and 2-5 years after surgery
measure: Incidence of Thoracic aortic dissection -related surgical conversion or re-intervention
timeFrame: 30 days，6 months, 12 months and 2-5 years after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospita
state: Beijing
city: Lanzhou
country: China
facility: The Frist Hospital of Lanzhou University
state: Gansu
city: Liuzhou
country: China
facility: LIU ZHOU WORKER'S HOSPITAL,Fourth Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Harbin
country: China
facility: The second affiliated hospital of Harbin medical university
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital,Tongji Medical College of Huazhong University of Science&Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital (Nanjing Gulou Yi Yuan), the Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Suzhou
country: China
facility: The first affiliated hospital of soochow university
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital Of Nanchang University
state: Jiangxi
city: Chang chun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Xi'an
country: China
facility: Xijing Hospital, The Fourth Military Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China hospital of sichuan university
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjing Medical University General Hospital
state: Tianjin
city: Kunming
country: China
facility: The first people's hospital of yunnan province
state: Yunnan
Study officials:
affiliation: Central South University
name: Chang Shu, professor
role: PRINCIPAL_INVESTIGATOR
References: