Common Iliac Artery AneurysmNCT06660927
The Study on the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System
A study testing liac Bifurcation Stent Graft System in people with Common Iliac Artery Aneurysm, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in China.
Trial summary
The objective of this study is to evaluate the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms(CIAA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Common Iliac Artery Aneurysm
- What is being tested?
- liac Bifurcation Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2021to 30 Nov 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone implantation of the iliac bifurcation stent graft system;
- Patients with complete medical records
Who cannot join
- Patients with ruptured aortic aneurysm;
- Patients with infected or mycotic aortic aneurysm;
- Patients with connective tissue diseases, such as systemic lupus erythematosus, Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms
The objective of this study is to evaluate the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms(CIAA).
Read the detailed description
The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee.
- Conditions
- Common Iliac Artery Aneurysm
- Being tested
- liac Bifurcation Stent Graft System
- Keywords
- Lifetech, Iliac Bifurcation Stent Graft System, Endovascular Repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liac Bifurcation Stent Graft SystemDevice
to evaluate the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms(CIAA)
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Treatment of Patients with Common Iliac Artery Aneurysms | Experimental | Endovascular Treatment of Patients with Common Iliac Artery Aneurysms Using the Iliac Bifurcation Stent Graft System Receives: Device: liac Bifurcation Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Major Adverse Events (MAE) within 30 Days postoperatively.
Major Adverse Events (MAE) are defined as follows: all-cause mortality related to iliac artery aneurysms associated with the surgery or device, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, and intestinal ischemia.
Measured: within 30 Days postoperatively
he patency rate of internal iliac artery (IIA) at 12 months postoperatively
The patency rate of internal iliac artery (IIA) defined as blood flow without occlusion maintained through the device without intervention
Measured: at 12 months postoperatively
Secondary outcomes (5)
The incidence of conversion to open surgery or secondary interventional procedures due to iliac artery aneurysms before discharge and at 12 months postoperatively.
Notes: Due to the patient's condition, the surgeon's choice of staged reconstruction does not constitute a secondary surgical intervention.
Measured: before discharge and at 12 months postoperatively
Device-related adverse events before discharge and at 12 months postoperatively
Device-related adverse events are those situations that are ultimately determined to be definitely related, possibly related, or indeterminate with respect to the study device.
Measured: before discharge and at 12 months postoperatively.
The incidence of malfunction before discharge and at 12 months postoperatively.
Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended.Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed.
Measured: before discharge and at 12 months postoperatively.
Incidence rate of Type I/III endoleak caused by the iliac bifurcation system that necessitate reintervention before discharge and at 12 months postoperatively.
Type I endoleak, also known as peri-graft endoleak or graft-related endoleak, refers to the leakage caused by the inability of the stent graft to tightly adhere to the autologous vessel, leading to continuous blood flow into the aneurysm sac. This includes proximal and distal Type I endoleaks. Type III endoleak refers to the leakage caused by the inability of the stent graft's own connectors to tightly adhere or the rupture of the artificial vessel, which results in continuous blood flow into the aneurysm sac.
Measured: before discharge and at 12 months postoperatively.
The immediate technical success during intraoperative procedures.
immediate technical success refers to successful delivery of the stent to the intended location by the delivery system, successful deployment of the stent, and safe removal of the delivery system. Additionally, angiography should show unobstructed blood flow within the stent, with no stent kinking, folding, narrowing, or occlusion.
Measured: during intraoperative procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start30 Nov 2021
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Iliac Artery AneurysmStudies of the same condition, open and under way.
- More trials run by Lifetech Scientific (Shenzhen) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- hongpeng zhang, Professor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660927
- Sponsor's protocol ID
- 50CT(CN) L-01
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms
- ClinicalTrials.gov ID
- NCT06660927
- Acronym / sponsor ID
- 50CT(CN) L-01
- Conditions
- Common Iliac Artery Aneurysm
- Keywords
- Lifetech, Iliac Bifurcation Stent Graft System, Endovascular Repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms(CIAA).
Detailed description
The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular Treatment of Patients with Common Iliac Artery Aneurysms | Experimental | Device: liac Bifurcation Stent Graft SystemEndovascular Treatment of Patients with Common Iliac Artery Aneurysms Using the Iliac Bifurcation Stent Graft System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have undergone implantation of the iliac bifurcation stent graft system;
- Patients with complete medical records
Key exclusion criteria (3 listed)
- Patients with ruptured aortic aneurysm;
- Patients with infected or mycotic aortic aneurysm;
- Patients with connective tissue diseases, such as systemic lupus erythematosus, Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liac Bifurcation Stent Graft Systemto evaluate the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms(CIAA) | Device | Endovascular Treatment of Patients with Common Iliac Artery Aneurysms |
Primary outcome
The Incidence of Major Adverse Events (MAE) within 30 Days postoperatively.
Time frame: within 30 Days postoperatively
Major Adverse Events (MAE) are defined as follows: all-cause mortality related to iliac artery aneurysms associated with the surgery or device, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, and intestinal ischemia.
he patency rate of internal iliac artery (IIA) at 12 months postoperatively
Time frame: at 12 months postoperatively
The patency rate of internal iliac artery (IIA) defined as blood flow without occlusion maintained through the device without intervention
5 secondary outcomes
The incidence of conversion to open surgery or secondary interventional procedures due to iliac artery aneurysms before discharge and at 12 months postoperatively.
Time frame: before discharge and at 12 months postoperatively
Device-related adverse events before discharge and at 12 months postoperatively
Time frame: before discharge and at 12 months postoperatively.
The incidence of malfunction before discharge and at 12 months postoperatively.
Time frame: before discharge and at 12 months postoperatively.
Incidence rate of Type I/III endoleak caused by the iliac bifurcation system that necessitate reintervention before discharge and at 12 months postoperatively.
Time frame: before discharge and at 12 months postoperatively.
The immediate technical success during intraoperative procedures.
Time frame: during intraoperative procedures
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
Related trials for Common Iliac Artery Aneurysm
Not yet recruiting
Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization
Common Iliac Artery Aneurysm, Aorto Iliac Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hongpeng zhang, Professor principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liac Bifurcation Stent Graft System in people with Common Iliac Artery Aneurysm, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site 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 2 inclusion and 3 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 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Incidence of Major Adverse Events (MAE) within 30 Days postoperatively. (time frame: within 30 Days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2024.