Aortic Aneurysm, AbdominalNCT06162273
An Exploratory Study of Iliac Artery Branch Stent for Internal Iliac Artery Reconstruction in Abdominal Aortic Aneurysm/Iliac Aneurysm Repair
An observational study of Aortic Aneurysm, Abdominal and Iliac Aneurysm, run by RenJi Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company in the treatment of abdominal aortic aneurysm/iliac aneurysm reconstruction of internal iliac artery Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Iliac Aneurysm
- What is being tested?
- IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with iliac aneurysms/abdominal aortic aneurysms requiring iliac branch stents
Who may be able to join
- Patients with iliac aneurysms combined with or without abdominal aortic aneurysms and internal iliac arteries reconstructed with iliac branch stents;
- Male or female ≥18 years old, ≤85 years old;
- Life expectancy > 2 years;
- The patient signed the informed consent voluntarily and was able to comply with the treatment plan and complete the follow-up and examination as planned.
Who cannot join
- Fungal or ruptured aneurysm
- Known complications of thoracic aortic aneurysm require interventional treatment
- American Association of Anesthesiologists (ASA) Grade V
- Creatinine > 2.5mg/dL or dialysis patients
- NYHA Grade IV heart failure
- Intercalation, severe calcification, or anchoring area with thrombosis
Show all 12Show fewer
- Severe curvature or narrowing of the iliac and/or femoral arteries, resulting in difficulty in stent delivery
- Conduct another device or drug study within 1 year of treatment
- Systemic infection
- Combined with connective tissue disease
- Known history of drug use
- Known allergies or allergies to equipment materials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing the Efficacy and Safety of IBD Stent of Shenzhen Xianjian Company and IBE Stent of American Gore Company for Reconstruction of Internal Iliac Artery in Abdominal Aortic Aneurysm/Iliac Aneurysm Repair
The purpose of this study is to evaluate the efficacy and safety of IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company in the treatment of abdominal aortic aneurysm/iliac aneurysm reconstruction of internal iliac artery
Read the detailed description
This study is a prospective observational exploratory cohort study without a control group. As a single-group target value validation study, the main evaluation indicator is the primary patency rate one year after surgery. As an exploratory study, considering the enrollment ability to facilitate data analysis, 40 subjects are enrolled in the final study, and 20 are expected to be included in each study. All enrolled patients will be followed for 12 months for CTA to assess primary patency. Telephone follow-up was conducted at 1, 3, 6, and 12 months for adverse events.
- Conditions
- Aortic Aneurysm, Abdominal, Iliac Aneurysm
- Being tested
- IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company
- Keywords
- Iliac artery branch stent, Patency rate, Internal iliac artery
- Medical subject headings
- Aortic Aneurysm, Abdominal, Iliac Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore companyDevice
Patients underwent endovascular treatment for reconstruction of internal iliac artery in abdominal aortic aneurysm/iliac aneurysm repair. The lesion will be treated by IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore Company.
| Study group | Role | What they receive |
|---|---|---|
| IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company | Patients underwent endovascular treatment for reconstruction of internal iliac artery in abdominal aortic aneurysm/iliac aneurysm repair. The lesion will be treated by IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore Company. Receives: Device: IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
CTA showed patency of the preserved internal iliac artery.
Measured: 12-month
Secondary outcomes (6)
New hip lameness
New hip lameness is defined as new hip claudication in the lateral body treated with an iliac artery branch stent.
Measured: 12-month
Internal leakage
Internal leakage is defined as any type of internal leakage that occurs during the follow-up period.
Measured: 12-month
Aneurysmal enlargement
Aneurysm enlargement is defined as having a larger aneurysm diameter during follow-up than before surgery.
Measured: 12-month
Aneurysm rupture
Ruptured aneurysms is defined as ruptured abdominal aortic aneurysms or iliac aneurysms that occurrs during follow-up.
Measured: 12-month
Secondary patency
Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.
Measured: 12-month
Secondary endovascular repair surgery
Secondary endovascular repair is defined as secondary surgical intervention that occurrs during follow-up due to adverse events such as internal leakage and distal limb ischemia.
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162273
- Sponsor's protocol ID
- The SIRI study
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy and Safety of IBD Stent of Shenzhen Xianjian Company and IBE Stent of American Gore Company for Reconstruction of Internal Iliac Artery in Abdominal Aortic Aneurysm/Iliac Aneurysm Repair
- ClinicalTrials.gov ID
- NCT06162273
- Acronym / sponsor ID
- The SIRI study
- Conditions
- Aortic Aneurysm, Abdominal, Iliac Aneurysm
- Keywords
- Iliac artery branch stent, Patency rate, Internal iliac artery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Dec 2023 (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 purpose of this study is to evaluate the efficacy and safety of IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company in the treatment of abdominal aortic aneurysm/iliac aneurysm reconstruction of internal iliac artery
Detailed description
This study is a prospective observational exploratory cohort study without a control group. As a single-group target value validation study, the main evaluation indicator is the primary patency rate one year after surgery. As an exploratory study, considering the enrollment ability to facilitate data analysis, 40 subjects are enrolled in the final study, and 20 are expected to be included in each study. All enrolled patients will be followed for 12 months for CTA to assess primary patency. Telephone follow-up was conducted at 1, 3, 6, and 12 months for adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company | – | Device: IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore companyPatients underwent endovascular treatment for reconstruction of internal iliac artery in abdominal aortic aneurysm/iliac aneurysm repair. The lesion will be treated by IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore Company. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with iliac aneurysms/abdominal aortic aneurysms requiring iliac branch stents
Key inclusion criteria (4 listed)
- Patients with iliac aneurysms combined with or without abdominal aortic aneurysms and internal iliac arteries reconstructed with iliac branch stents;
- Male or female ≥18 years old, ≤85 years old;
- Life expectancy > 2 years;
- The patient signed the informed consent voluntarily and was able to comply with the treatment plan and complete the follow-up and examination as planned.
Key exclusion criteria (12 listed)
- Fungal or ruptured aneurysm
- Known complications of thoracic aortic aneurysm require interventional treatment
- American Association of Anesthesiologists (ASA) Grade V
- Creatinine > 2.5mg/dL or dialysis patients
- NYHA Grade IV heart failure
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 |
|---|---|---|
| IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore companyPatients underwent endovascular treatment for reconstruction of internal iliac artery in abdominal aortic aneurysm/iliac aneurysm repair. The lesion will be treated by IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore Company. | Device | IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company |
Primary outcome
Primary patency
Time frame: 12-month
CTA showed patency of the preserved internal iliac artery.
6 secondary outcomes
New hip lameness
Time frame: 12-month
Internal leakage
Time frame: 12-month
Aneurysmal enlargement
Time frame: 12-month
Aneurysm rupture
Time frame: 12-month
Secondary patency
Time frame: 12-month
Secondary endovascular repair surgery
Time frame: 12-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm, Abdominal and Iliac Aneurysm, run by RenJi Hospital 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 4 inclusion and 12 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: opening soon, as of the sponsor's last update on 8 Dec 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guanhua Xue, M.D. (13585785270, guanhuaxue@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency (time frame: 12-month). 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 8 Dec 2023.