Status:
COMPLETED
Prospective Study for Aortic Arch Therapy With stENt-graft for Chimney technologY（PATENCY）
Lead Sponsor:
Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions:
Thoracic Aortic Dissection
Eligibility:
All Genders
18-85 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- Patients are 18 years and older, but less than 85 years old and not pregnant or lactating;
- 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;
- Patients diagnosed as thoracic aortic dissection involving the arch, and the left subclavian artery branching vessel needs to be revascularized;
- Aortic proximal landing zone ≥15mm；
- Aortic proximal diameter in the range of 25-44mm;
- The left subclavian artery distal landing zone≥15mm;
- The left subclavian artery diameter in the range of 5-18mm；
- Patients who have eligible imported arterial vessels.
Exclusion
- Patients with severe stenosis, calcification in the landing area of the stent and easily lead to incomplete stent apposition;
- 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；
- Patients with a history of myocardial infraction or acute coronary syndromes in 3 months；
- Patients with a history of cerebrovascular events or gastrointestinal bleeding in 3 months, antiplatelet agent and anticoagulant contraindication, or tendency of hemorrhage；
- Patients have received any major surgical or interventional therapy within 30 days (Operation Classification reaches III or above) or have received interventional therapy;
- Patients will receive any major selective operation or interventional therapy in 30days (Operation Classification reaches III or above) or will received interventional therapy;
- 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；
- Patients with genetic connective tissue disease (e.g., Marfans syndrome) or aorta hereditary disease；
- Patients with infectious aortic dissection;
- Patients with acute systemic infection;
- Patients with major organ failure or other serious diseases;
- Patients with a history of active bleeding, clotting disorder, or rejection of blood transfusions;
- 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;
- Pregnant or lactating women or women who plan to get pregnant;
- Patients who can not tolerate to Anaesthetic；
- Patients with a history of allergy to contrast media, stents and conveyor materials (including nickel and titanium, polyester, PTFE, and nylon polymer materials);
- Patients with a life expectancy less than 12 months（such as terminal malignant tumor）；
- Patients who were not suitable for endovascular treatment, judged by the investigator;
- Patients who participated in clinical trials of other drugs or medical devices at the same time.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03767777
Start Date
February 1 2019
End Date
June 1 2025
Last Update
June 18 2025
Active Locations (21)
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1
Fuwai hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100037
2
Chinese PLA General Hospita
Beijing, Beijing Municipality, China
3
The Frist Hospital of Lanzhou University
Lanzhou, Gansu, China
4
LIU ZHOU WORKER'S HOSPITAL,Fourth Affiliated Hospital of Guangxi Medical University
Liuchow, Guangxi, China