Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System

NCT03687489 | Unknown DMC

• 1 other identifier: LTAAA-01
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 22

Brief Summary

A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Abdominal Aortic Aneurysm Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for the infrarenal abdominal aortic aneurysm.

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic Aneurysm Stent Graft System

Outcome Measures

Primary Outcomes (1)

• The success rate of abdominal aortic aneurysm treatment

  A successful abdominal aortic aneurysm treatment is a composite index and refers to the following criteria simultaneously: 1. the immediate technical success (the immediate technical success refers to the delivery system is successfully delivered to a predetermined location, the abdominal aortic stent is successfully deployed, and the transporter can be safely withdrawn from the body). 2. the increase of maximum diameter of abdominal aortic aneurysm at the 12th month after surgery ≤5mm, compared with that before surgery. 3. The displacement of anterior abdominal aortic stent was no more than 10mm at the 12th month after the operation from the location before discharge. 4. No type I or type III leakage requiring additional intervention occurred 12 months after surgery。 No abdominal aortic aneurysm rupture within 12 months after surgery.

  12 months after operation

Secondary Outcomes (10)

• The incidence of Major Adverse Event (MAE)

  30 days after surgery

• Incidence of type I or III leakage

  6 months, 12 months after surgery

• The incidence of abdominal aortic stent displacement

  6 months, 12 months after surgery

• Operation efficacy - incidence of conversion from abdominal aortic aneurysm treatment to open surgery or secondary surgery

  6 months, 12 months and 2-5 years after surgery.

• The incidence rate of perioperative delivery related complications

  intraoperative and postoperative 30 days.

Study Arms (1)

Intervention arm

EXPERIMENTAL

Participants will be treated with Abdominal Aortic Aneurysm Stent Graft System

Device: Abdominal Aortic Aneurysm Stent Graft System

Interventions

Abdominal Aortic Aneurysm Stent Graft System DEVICE

Abdominal aortic bifurcation stent and iliac artery extension stent were preloaded into abdominal aortic bifurcation stent transporter and iliac artery extension stent transporter, respectively. In the operation, the abdominal aorta bifurcation stent and the iliac artery extension stent will be delivered to the corresponding lesion position of the abdominal iliac artery and release. The abdominal aortic bifurcation stent and the iliac artery extension stent will form a whole through docking and thereby reducing the risk of rupture of an infrarenal abdominal aortic aneurysm due to the shock of blood flow.

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 aged greater than 18 years old and less than 85 years old, regardless of gender.
• \. 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 with Infrarenal Abdominal Aortic Aneurysm and should meet at least one of the following conditions:
• The maximum diameter of abdominal aortic aneurysm ≥50mm in male patients, or the maximum diameter of abdominal aortic aneurysm ≥45mm in female patients.
• The maximum diameter of abdominal aortic aneurysm ≥40mm and the diameter increased by more than 5mm in the last 6 months (In this case, the diameter data of abdominal aortic aneurysm should be traceable within 6 months).
• The abdominal aortic aneurysm compresses vital organs and causes symptoms (such as abdominal pain, lower back pain, etc.) 4. The range of proximal aneurysm neck diameter of the abdominal aortic aneurysm is between 17mm to 32mm.
• \. The length of the proximal aneurysm neck of abdominal aortic aneurysm≥10mm, and the angle of the proximal aneurysm neck ≤75 °.
• \. The range of the diameter of the iliac artery anchoring area is between 8mm to 22mm.
• The length of the iliac artery anchoring area≥15mm.
• \. The patient has a suitable iliac and femoral artery approach.

You may not qualify if:

• \. Patients with severe stenosis, calcification, or mural thrombus in the anchoring area of the stent and easily lead to incomplete stent apposition.
• \. Patients with rupture of an abdominal aortic aneurysm or threatened rupture.
• \. Patients with abdominal aortic dissection.
• \. Patients with mycotic or infectious abdominal aortic aneurysms.
• \. Patients with a history of myocardial infarction or unstable angina pectoris for 6 months. Characteristics of unstable angina pectoris: angina symptoms gradually increased, new onset of rest or night angina pectoris or occurrence of angina prolonged.
• \. Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months.
• \. Patients with a history of allergy to contrast media, stents and conveyor materials (including nickel and titanium, polyester, PTFE, and nylon polymer materials).
• \. A patient with connective tissue diseases such as Marfan syndrome, Eaton syndrome, or Bessel's disease.
• \. Patients with liver dysfunction: Alanine transaminase (ALT) or Aspartate transaminase (AST) were five times higher than the normal upper limit；serum total bilirubin (STB) was two times higher than the normal upper limit.
• \. Patients with renal dysfunction: Serum creatinine (Cr) was two times higher than the normal upper limit.
• \. Life expectancy is less than one year.
• \. Patients with major organ failure or other serious diseases;
• \. Patients who were not suitable for endovascular treatment, judged by the investigator.
• \. Pregnant or lactating women or women who plan to get pregnant.
• \. The patients participated in other clinical trials and did not come out of the group or withdraw within the first 3 months of the screening period of this trial.

Sponsors & Collaborators

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

Study Sites (22)

Chinese PLA General Hospita

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

The Frist Hospital of Lanzhou University

Lanzhou, Gansu, China

Location

Liuzhou General Hospital

Liuchow, Guangxi, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

The Second Hospital of Heibei Medical University

Shijiazhuang, Hebei, China

Location

Renming Hospital of Wuhan University

Wuhan, Hubei, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 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

Xijing Hospital, The Fourth Military Medical University

Xi’an, Shanxi, China

Location

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Location

Tianjing Medical University General Hospital

Tianjin, Tianjin Municipality, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

Frist Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Yan'an Hospital of Kunming City

Kunming, Yunnan, China

Location

The Frist Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Wei Guo, Professor

  Chinese PLA General Hospita

  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: September 25, 2018
• First Posted: September 27, 2018
• Study Start: September 30, 2018
• Primary Completion: November 30, 2020
• Study Completion: March 31, 2025
• Last Updated: December 30, 2019

Record last verified: 2019-12

Locations

CN (22)