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

NCT03767777 | Completed DMC

• 1 other identifier: LTP84-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 21

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.

Conditions

Thoracic Aortic Dissection

Keywords

Aortic arch; Aortic disease; Aortic Dissection; Stent Graft

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• Incidence of all-cause death

  30 days，6 months, 12 months and 2-5 years after surgery

• Incidence of Aortic dissection dissection-related death

  30 days，6 months, 12 months and 2-5 years after surgery

• Incidence of Serious Major Adverse Event（SAE）

  30 days，6 months, 12 months and 2-5 years after surgery

• Incidence of device related adverse events（AE）

  30 days，6 months, 12 months and 2-5 years after surgery

• Incidence of left upper limb ischemia

  30 days，6 months, 12 months and 2-5 years after surgery

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Device: Artery Stent Graft System

Interventions

Artery Stent Graft System DEVICE

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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；

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (21)

Fuwai hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Location

Chinese PLA General Hospita

Beijing, Beijing Municipality, China

Location

The Frist Hospital of Lanzhou University

Lanzhou, Gansu, China

Location

LIU ZHOU WORKER'S HOSPITAL,Fourth Affiliated Hospital of Guangxi Medical University

Liuchow, Guangxi, China

Location

The second affiliated hospital of Harbin medical university

Harbin, Heilongjiang, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Location

The Central Hospital of Wuhan

Wuhan, Hubei, China

Location

Tongji Hospital,Tongji Medical College of Huazhong University of Science&Technology

Wuhan, Hubei, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Nanjing Drum Tower Hospital (Nanjing Gulou Yi Yuan), the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Location

The first affiliated hospital of soochow university

Suzhou, Jiangsu, China

Location

The Second Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Shandong Provincial Hospital

Jinan, Shandong, China

Location

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Location

Xijing Hospital, The Fourth Military Medical University

Xi’an, Shanxi, China

Location

West China hospital of sichuan university

Chengdu, Sichuan, China

Location

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Location

Tianjing Medical University General Hospital

Tianjin, Tianjin Municipality, China

Location

The first people's hospital of yunnan province

Kunming, Yunnan, China

Location

Related Publications (2)

• Shu C, Wan Z, Luo M, Fang K, Hu J, Zuo J, Li X, Li Q, He H, Li X. Mid-term results of a prospective study for aortic dissection with a gutter-plugging chimney stent graft. Eur J Cardiothorac Surg. 2024 May 3;65(5):ezae135. doi: 10.1093/ejcts/ezae135.

  PMID: 38569918 DERIVED

• Liu Y, Fang K, Luo MY, Xiao ZH, Yang P, Lu C, Zhang Y, Wang HY, Xie Y, Xu ZY, Zhang HW, Shu C, Hu J. Single-Center Preliminary Experience with Gutter-Plugging Chimney Stent-Graft for Aortic Dissection. Cardiovasc Intervent Radiol. 2023 Jun;46(6):703-712. doi: 10.1007/s00270-023-03444-8. Epub 2023 May 17.

  PMID: 37198293 DERIVED

MeSH Terms

Conditions

Dissection, Thoracic Aorta; Aortic Diseases; Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome

Study Officials

• Chang Shu, professor

  Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 7, 2018
• Study Start: February 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

CN (21)