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Abdominal Aortic AneurysmNCT03687489

Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System

A study testing Abdominal Aortic Aneurysm Stent Graft System in people with Abdominal Aortic Aneurysm, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 22 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Abdominal Aortic Aneurysm
What is being tested?
Abdominal Aortic Aneurysm Stent Graft System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
22 sitesChina
Study dates
30 Sep 2018to 31 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients aged greater than 18 years old and less than 85 years old, regardless of gender.
  • 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 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.
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  • 5. The length of the proximal aneurysm neck of abdominal aortic aneurysm≥10mm, and the angle of the proximal aneurysm neck ≤75 °.
  • 6. The range of the diameter of the iliac artery anchoring area is between 8mm to 22mm.
  • 7.The length of the iliac artery anchoring area≥15mm.
  • 8. The patient has a suitable iliac and femoral artery approach.

Who cannot join

  • 1. Patients with severe stenosis, calcification, or mural thrombus in the anchoring area of the stent and easily lead to incomplete stent apposition.
  • 2. Patients with rupture of an abdominal aortic aneurysm or threatened rupture.
  • 3. Patients with abdominal aortic dissection.
  • 4. Patients with mycotic or infectious abdominal aortic aneurysms.
  • 5. 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.
  • 6. Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months.
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  • 7. Patients with a history of allergy to contrast media, stents and conveyor materials (including nickel and titanium, polyester, PTFE, and nylon polymer materials).
  • 8. A patient with connective tissue diseases such as Marfan syndrome, Eaton syndrome, or Bessel's disease.
  • 9. 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.
  • 10. Patients with renal dysfunction: Serum creatinine (Cr) was two times higher than the normal upper limit.
  • 11. Life expectancy is less than one year.
  • 12. Patients with major organ failure or other serious diseases;
  • 13. Patients who were not suitable for endovascular treatment, judged by the investigator.
  • 14. Pregnant or lactating women or women who plan to get pregnant.
  • 15. 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.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

China22 sites

  • Chinese PLA General Hospita

    Beijing, Beijing Municipality

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • Xiangya Hospital Central South University

    Changsha, Hunan

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

  • The Frist Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • Shandong Provincial Hospital

    Jinan, Shandong

  • Frist Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • Yan'an Hospital of Kunming City

    Kunming, Yunnan

  • The Frist Hospital of Lanzhou University

    Lanzhou, Gansu

  • Liuzhou General Hospital

    Liuzhou, Guangxi

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

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

    Shanghai, Shanghai Municipality

  • The Second Hospital of Heibei Medical University

    Shijiazhuang, Hebei

  • Tianjing Medical University General Hospital

    Tianjin, Tianjin Municipality

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

  • Renming Hospital of Wuhan University

    Wuhan, Hubei

  • Xijing Hospital, The Fourth Military Medical University

    Xi’an, Shanxi

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia

Other trials in China

About this study

Official title: Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System for Infrarenal Abdominal Aortic Aneurysm: A Prospective, Multi-center, Objective Performance Criteria Clinical Trial

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.

Read the detailed description

This clinical trial was conducted in a qualified clinical trial institution. Investigators will use Abdominal Aortic Aneurysm Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. to treat patients with Infrarenal Abdominal Aortic Aneurysm. 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 March 2018, and complete the implantation of 156 patients in 22 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 abdominal aortic aneurysm treatment 12 months after surgery. This trail will evaluate whether the device reached the secondary safety endpoint and primary efficacy endpoint through several secondary endpoint indicators: Perioperative (intraoperative to postoperative 30 days) delivery related complications incidence rate (including the transabdominal surgery caused by intraoperative conveyors, the hemorrhage in the middle iliac artery, the hemorrhage in the femoral artery at the puncture site, the hematoma and the pseudoaneurysm), the incidence of acute lower limb ischemia before discharge and 30 days after surgery, all-cause mortality at 6 months, 12 months and 2-5 years after surgery, abdominal aortic aneurysm-related mortality at 6 months, 12 months and 2-5 years after surgery, the incidence of severe adverse events (SAE) at 6 months, 12 months and 2-5 years after surgery, the incidence of the device-related adverse events (AE) at 6 months, 12 months and 2-5 years after surgery, the incidence of type I or type III leakage at 6 months, 12 months after surgery, the incidence of displacement of Abdominal Aortic Aneurysm Stent at 6 months, 12 months after surgery and the incidence of conversion from abdominal aortic aneurysm treatment to open surgery or secondary surgery intervention at 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 CFDA listing registration after completing a 12-month primary endpoint assessment. According to the guidelines for clinical trials of aortic covered stent system, the sponsor will apply for CFDA 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.

Being tested
Abdominal Aortic Aneurysm Stent Graft System
Keywords
Abdominal Aortic Aneurysm Stent Graft System
Medical subject headings
Aortic Aneurysm, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abdominal Aortic Aneurysm Stent Graft SystemDevice

    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.

Study groups in NCT03687489
Study groupRoleWhat they receive
Intervention armExperimentalParticipants will be treated with Abdominal Aortic Aneurysm Stent Graft System
Receives: Device: Abdominal Aortic Aneurysm Stent Graft System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months after operation

Secondary outcomes (10)

  1. The incidence of Major Adverse Event (MAE)

    Major Adverse Event (MAE) is defined as all-cause death, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, and intestinal ischemia.

    Measured: 30 days after surgery

  2. Incidence of type I or III leakage

    Type I leakage is also known as peripheral leakage or graft related leakage, which refers to internal leakage resulting from the inability of stent-type blood vessels to adhere closely to an autologous blood vessel, and the blood flow continues to flow into the aneurysm cavity, including proximal type I and distal type I leakage. Type III leakage refers to leakage caused by the failure of stent-type vessels to bind themselves tightly or the rupture of artificial vessels, and the blood flow continues to flow into the aneurysm cavity.

    Measured: 6 months, 12 months after surgery

  3. The incidence of abdominal aortic stent displacement

    The displacement refers to the position of abdominal aorta stents of postoperative follow-up are displaced more than 10 mm from the before discharge position.

    Measured: 6 months, 12 months after surgery

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

    The incidence of conversion from abdominal aortic aneurysm treatment to open surgery or secondary surgery intervention.

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

  5. The incidence rate of perioperative delivery related complications

    Perioperative period refers to intraoperative time to 30 days postoperative. Delivery related complications incidence including he transabdominal surgery caused by intraoperative conveyors, the hemorrhage in the middle iliac artery, the hemorrhage in the femoral artery at the puncture site, the hematoma and the pseudoaneurysm.

    Measured: intraoperative and postoperative 30 days.

  6. The incidence of Acute lower limb ischemia.

    The incidence of acute lower limb ischemia.

    Measured: Before discharge and 30 days after surgery

  7. All-cause mortality

    All-cause mortality evaluates at 6 months, 12 months and 2-5 years after surgery

    Measured: 6 months, 12 months and 2-5 years after surgery

  8. Disease related mortality

    Abdominal aortic aneurysm-related mortality evaluates at 6 months, 12 months and 2-5 years after surgery.

    Measured: 6 months, 12 months and 2-5 years after surgery

  9. Severe adverse events (SAE)

    The incidence of severe adverse events (SAE). According to the ISO 14155 SAE refers to

    1. led to death,
    2. led to serious deterioration in the health of the subject, that either resulted in
    3. a life-threatening illness or injury, or
    4. a permanent impairment of a body structure or a body function, or
    5. in-patient or prolonged hospitalization, or
    6. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
    7. led to foetal distress, foetal death or a congenital abnormality or birth defect

    Measured: 6 months, 12 months and 2-5 years after surgery

  10. Device-related adverse effects (AE)

    The incidence of the device-related adverse effects (AE), according to the ISO14155, adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.

    Measured: 6 months, 12 months and 2-5 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2018
  2. Study start30 Sep 2018
  3. Primary completion30 Nov 2020 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03687489
Sponsor's protocol ID
LTAAA-01
Status last verified
Dec 2019
First submitted
25 Sep 2018
Last updated
30 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Abdominal Aortic Aneurysm Stent Graft System in people with Abdominal Aortic Aneurysm, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 22 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The success rate of abdominal aortic aneurysm treatment (time frame: 12 months after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03687489.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.

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