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

LifeTech Scientific

Status: Completed

Conditions: Thoracic Aortic Dissection

Treatments: Device: Artery Stent Graft System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03767777

LTP84-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Intervention arm

Experimental group

Description:

Participants will be treated with Artery Stent Graft System Intervention: Device: Artery Stent Graft System

Treatment:

Device: Artery Stent Graft System