Aortoiliac AneurysmNCT03686189
Safety and Efficacy Study of Iliac Bifurcation Stent Graft System
A study testing Iliac Bifurcation Stent Graft System in people with Aortoiliac Aneurysm and Iliac Aneurysm, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 8 sites in China.
Trial summary
A prospective, multi-centre, single-arm clinical trial to evaluate the safety and efficacy of Iliac Bifurcation Stent Graft System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortoiliac Aneurysm, Iliac Aneurysm
- What is being tested?
- Iliac Bifurcation Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 8 sitesChina
- Study dates
- 2 Jul 2015to 31 Jan 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years of age.
- The subject or its legal representative sign the informed consent.
- Patients with the aortoiliac aneurysm or the iliac aneurysm and need to endovascular restructure the internal iliac artery.
- The anatomical structure of the iliac artery meets the following requirements:
- The length of the anchoring zone of the external iliac artery is ≥15mm.
- The diameter of the anchoring zone of the external iliac artery is between 7mm and 12mm.
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- The diameter of the external iliac artery is between 6mm-10mm.
- The length of the anchoring zone of the internal iliac artery is ≥10mm.
- Life expectancy is longer than one year.
Who cannot join
- The patient is under 18 years old.
- Pregnant or lactating woman.
- The patient had a myocardial infarction or stroke within 3 months.
- The patient had connective tissue disease, infectious aneurysm, and other active infections.
- The patient has abdominal aortic aneurysm rupture.
- The patient has a severe coagulation disorder.
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- Allergic to the material of stent or contrast media.
- Patient's vascular morphology is not suitable for endovascular repairs, such as serious stricture, dilate, bend, sclerosis, etc. of the iliac artery.
- Patients with severe mural thrombus in the aneurysm cavity, which may affect the implantation of Branch Stent.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Beijing Anzhen Hospital, Capital Medical university
Beijing, Beijing Municipality
Chinese PLA General Hospital
Beijing, Beijing Municipality
Peking Union Medical College Hospital
Beijing, Beijing Municipality
The Second Xiangya Hospital of Central South University
Changsha, Hunan
The Frist Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang
Jiangsu Province Hospital
Nanjing
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
About this study
Official title: Safety and Efficacy Study of Iliac Bifurcation Stent Graft System, A Prospective, Multi-centre, Single-Arm Clinical Trial
A prospective, multi-centre, single-arm clinical trial to evaluate the safety and efficacy of Iliac Bifurcation Stent Graft System.
Read the detailed description
A prospective, multi-center, Single-Arm clinical trial to evaluate the safety and efficacy of endovascular treatment of the aortoiliac aneurysm or the iliac aneurysm by using Iliac Bifurcation Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. According to the requirements of the study, 64 patients preoperatively diagnosed with the aortoiliac aneurysm or the iliac aneurysm will be recruited and be treated by Iliac Bifurcation Stent Graft System under the guidance of aortic aortography. The safety of operations, stability of releasing stent and the accuracy of positioning will be evaluated intraoperatively. The safety and efficacy of aortic endovascular treatment of Iliac Bifurcation Stent Graft System will be observed by postoperative follow up scheduled 30 days and 180 days after the operation.
- Conditions
- Aortoiliac Aneurysm, Iliac Aneurysm
- Being tested
- Iliac Bifurcation Stent Graft System
- Keywords
- Iliac Bifurcation Stent Graft System
- Medical subject headings
- Iliac Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iliac Bifurcation Stent Graft SystemDevice
Device placement after preoperative preparation. For patients with the aortoiliac aneurysm, the placement of short-bodied iliac artery bifurcation stent graft combined with the placement of the abdominal aortic stent graft, or the placement of long-bodied iliac artery bifurcation stent graft combined with the placement of the abdominal aortic stent graft are recommended.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Participants will be treated with Iliac Bifurcation Stent Graft System Receives: Device: Iliac Bifurcation Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency rate of internal iliac artery
Patency rate of internal iliac artery >＝89%
Measured: 180days postoperative
Secondary outcomes (5)
Technical success rate
After implantation of the stent and observed under common iliac artery angiography, the stent was in the right position and adhered well to the vessel wall, with no leakage.
Measured: immediate
Clinical success rate
The diameter of the common iliac artery aneurysm was not expanded or expanded less than 3mm.
Measured: 30 days and 180days postoperative.
The incidence of major Adverse Device Effects (ADEs)
Major Adverse Device Effects including death, myocardial infarction, arterial thrombosis, renal function failure, respiratory failure, paraplegia, stroke, gluteus claudication, colon, spinal cord ischemia necrosis, perineum, iliac artery blockages, external iliac vein blockage, expand common iliac artery aneurysms (increased diameter 3 mm), common iliac artery aneurysms rupture, internal leakage (type I and type III), stent fracture, stent displacement.
Measured: Before discharge, 30 days and 180 days postoperative。
Device related mortality
Deaths related to the device.
Measured: Before discharge, 30 days and 180days postoperative.
Secondary interventional surgery
The rate of secondary interventional surgery for complications related to the device
Measured: Before discharge, 30 days and 180days postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start2 Jul 2015
- Primary completion30 Nov 2018 (estimated)
- Study completion31 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortoiliac 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Guo, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686189
- Sponsor's protocol ID
- 50CT（CN）
- Status last verified
- Sep 2018
- First submitted
- 25 Sep 2018
- Last updated
- 28 Sep 2018
- 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 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Iliac Bifurcation Stent Graft System, A Prospective, Multi-centre, Single-Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT03686189
- Acronym / sponsor ID
- 50CT（CN）
- Conditions
- Aortoiliac Aneurysm, Iliac Aneurysm
- Keywords
- Iliac Bifurcation Stent Graft System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2015 (actual)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 31 Jan 2019 (estimated)
- First posted
- 26 Sep 2018 (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.
A prospective, multi-centre, single-arm clinical trial to evaluate the safety and efficacy of Iliac Bifurcation Stent Graft System.
Detailed description
A prospective, multi-center, Single-Arm clinical trial to evaluate the safety and efficacy of endovascular treatment of the aortoiliac aneurysm or the iliac aneurysm by using Iliac Bifurcation Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. According to the requirements of the study, 64 patients preoperatively diagnosed with the aortoiliac aneurysm or the iliac aneurysm will be recruited and be treated by Iliac Bifurcation Stent Graft System under the guidance of aortic aortography. The safety of operations, stability of releasing stent and the accuracy of positioning will be evaluated intraoperatively. The safety and efficacy of aortic endovascular treatment of Iliac Bifurcation Stent Graft System will be observed by postoperative follow up scheduled 30 days and 180 days after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: Iliac Bifurcation Stent Graft SystemParticipants will be treated with Iliac Bifurcation Stent Graft System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Older than 18 years of age.
- The subject or its legal representative sign the informed consent.
- Patients with the aortoiliac aneurysm or the iliac aneurysm and need to endovascular restructure the internal iliac artery.
- The anatomical structure of the iliac artery meets the following requirements:
- Life expectancy is longer than one year.
Key exclusion criteria (9 listed)
- The patient is under 18 years old.
- Pregnant or lactating woman.
- The patient had a myocardial infarction or stroke within 3 months.
- The patient had connective tissue disease, infectious aneurysm, and other active infections.
- The patient has abdominal aortic aneurysm rupture.
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 |
|---|---|---|
| Iliac Bifurcation Stent Graft SystemDevice placement after preoperative preparation. For patients with the aortoiliac aneurysm, the placement of short-bodied iliac artery bifurcation stent graft combined with the placement of the abdominal aortic stent graft, or the placement of long-bodied iliac artery bifurcation stent graft combined with the placement of the abdominal aortic stent graft are recommended. | Device | Intervention arm |
Primary outcome
Patency rate of internal iliac artery
Time frame: 180days postoperative
Patency rate of internal iliac artery >＝89%
5 secondary outcomes
Technical success rate
Time frame: immediate
Clinical success rate
Time frame: 30 days and 180days postoperative.
The incidence of major Adverse Device Effects (ADEs)
Time frame: Before discharge, 30 days and 180 days postoperative。
Device related mortality
Time frame: Before discharge, 30 days and 180days postoperative.
Secondary interventional surgery
Time frame: Before discharge, 30 days and 180days postoperative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
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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. This study is not recruiting at the moment.
Wei Guo principal investigator
Chinese PLA General Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iliac Bifurcation Stent Graft System in people with Aortoiliac Aneurysm and Iliac Aneurysm, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 8 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 9 inclusion and 9 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 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Patency rate of internal iliac artery (time frame: 180days postoperative). 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 Sep 2018.