Arteriosclerosis ObliteransNCT06485622
Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans
An observational study of Arteriosclerosis Obliterans, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study is a prospective, single-center, observational study. In this study, we aim to evaluate the clinical outcome and cost-effectiveness of different treatments of lower extremity arterial occlusive disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriosclerosis Obliterans
- What is being tested?
- open bypass group, bare metal stent group and plain old balloon angioplasty group
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to Jul 2029
- How long will I take part?
- 3 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: lower extremity arteriosclerosis obliterans
Who may be able to join
- Age 18 years or older, gender is not limited.
- Patients diagnosed with arteriosclerosis obliterans.
- Rutherford stages 2-6.
- When there are multiple stenosis lesions, the treatment of the most severe lesion is included.
- Patients with at least one arterial occlusion ( iliac, femoral, popliteal, anterior tibial, posterior tibial, and/or peroneal artery) of the lower extremity were included.
Who cannot join
- Malignant tumor
- Alzheimer's disease
- Blood disease or bleeding tendency
- Heart Failure Grade III ~ IV
- Pregnancy or lactation
- An above-knee-below-knee amputation has been performed
Show all 11Show fewer
- Unable to accept therapeutic function tests
- Life expectancy is less than six months
- Combined with other diseases affecting walking
- Cardiovascular and cerebrovascular events occurred within 3 months, including non-fatal myocardial infarction, unstable angina, stable angina, non-fatal ischemic stroke and hemorrhagic stroke
- Patients with significant abnormal liver and renal function that the investigators judged to be clinically significant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510030
Zilun Li, Doctor, 13760871576, lizilun@mail.sysu.edu.cn
About this study
Official title: Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans: a Prospective, Single-center, Observational Study
This study is a prospective, single-center, observational study. In this study, we aim to evaluate the clinical outcome and cost-effectiveness of different treatments of lower extremity arterial occlusive disease. It is expected to include about 400 patients diagnosed with lower extremity arterial occlusive disease in our center from July 2024 to July 2026. All enrolled patients will be followed for three years. All patients diagnosed with arteriosclerosis obliterans (ASO) and all treatment techniques were included in this study. The primary outcomes include the Efficacy and Safety End Points of each techniques.
Read the detailed description
Arteriosclerosis obliterans (ASO) is a kind of lower extremity arterial disease which occurs frequently in middle-aged and elderly people. The incidence of ASO increases with age. In patients with ASO, the build-up of fatty deposits, cholesterol, and other substances (plaques) in the arteries reduces blood flow to the extremities. This can lead to symptoms such as leg pain, cramping, and fatigue, especially during physical activity. In severe cases, it may result in pain at rest, non-healing wounds, and complications such as tissue damage or infection. Chronic wound is one of the symptoms that affect the quality of life. Therefore, wound healing is also an important index for postoperative care. However, no study has reported detailed performance data for different treatments. As an auxiliary method in clinical treatment, nutrition plays an important role in improving the clinical outcome of patients in the development and postoperative stages of the disease. The effect of nutritional risk assessment and nutritional education on postoperative symptoms of ASO has not been reported. Therefore, we plan to carry out this prospective, single-center, observational study, providing new data on the efficacy, safety and cost-effectiveness for different treatment and assistive techniques in lower extremity arterial occlusive disease.
- Conditions
- Arteriosclerosis Obliterans
- Being tested
- open bypass group, bare metal stent group, plain old balloon angioplasty group, drug-coated balloon group, directional atherectomy group
- Medical subject headings
- Arteriosclerosis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open bypass groupProcedure or surgery
After heparinization, the target artery is clamped above and below the anastomosis. The target artery is dissected along the anterior wall, calcium portions or mural thrombus are removed. Graft (autologous or prosthetic graft) is cut obliquely and anastomosis suturing starts with distal angle. Next stage is tunnel creating for graft conduction.
bare metal stent groupProcedure or surgery
Bare metal stent implantation during the index procedure.
plain old balloon angioplasty groupProcedure or surgery
Only plain old balloon was used during the index procedure.
drug-coated balloon groupProcedure or surgery
Drug-coated balloon was used during the index procedure.
directional atherectomy groupProcedure or surgery
Directional atherectomy (with or without drug-coated balloon) during the index procedure.
hybrid repair groupProcedure or surgery
Femoral artery arteriotomy. Further execute a direct endarterectomy femoral artery and from the mouth of a hip artery. Arteriotomy of the femoral artery is closed with a vascular patch use (synthetic or biological). Endovascular revascularization followed.
| Study group | Role | What they receive |
|---|---|---|
| Bypass group | open bypass group Receives: Procedure: open bypass group | |
| BMS group | BMS (bare metal stent) group Receives: Procedure: bare metal stent group | |
| POBA group | POBA (plain old balloon angioplasty) group Receives: Procedure: plain old balloon angioplasty group | |
| DCB group | drug-coated balloon group Receives: Procedure: drug-coated balloon group | |
| DA group | DA (directional atherectomy) group Receives: Procedure: directional atherectomy group | |
| HR group | HR (hybrid repair) group Receives: Procedure: hybrid repair group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb salvage rate
Freedom from above ankle amputation in target limb.
Measured: 1 month; 6 months; 12 months; 24 months; 36 months
Primary patency rate
Primary patency of target lesion is assessed by the vascular ultrasound.
Measured: 1 month; 6 months; 12 months; 24 months; 36 months
Major adverse limb event (MALE) rate
Major adverse limb events include anyone of the following: Amputation in target limb and major re-intervention on target limb.
Measured: 1 month; 6 months; 12 months; 24 months; 36 months
All cause mortality rate
Death due to any cause.
Measured: 1 month; 6 months; 12 months; 24 months; 36 months
Secondary outcomes (4)
Restenosis of the target lesion
A peak systolic velocity ratio of over 2.4 measured using duplex ultrasound, >50% diameter stenosis or occlusion by follow-up angiography.
Measured: 1 month; 6 months; 12 months; 24 months; 36 months
Major adverse cardiovascular events (MACE)
Major adverse cardiovascular events include anyone of the following: Major amputations, myocardial infarction, ischemic stroke, arterial puncture problems requiring intervention, and acute kidney failure associated with endovascular therapy.
Measured: 1 month; 6 months; 12 months; 24 months; 36 months
Quality-adjusted life-years (QALYs)
Time is measured in years and the VascuQol (Vascular Quality-of-Life, scored on a scale from 1 to 7 by using the VascuQol-25 questionnaire) on an index scale ranging from 1 (worst possible) to 7(best possible). The total number of QALYs was calculated by multiplying the HRQoL index score (QALY weight) by the time spent in each health state. One QALY can be viewed as living for 1 year in the best possible health.
Measured: 1 month; 6 months; 12 months; 24 months; 36 months
Survival Rate
Telephone follow-up visit and/or medical chart review and/or publicly available records consultation for vital status.
Measured: 1 month; 6 months; 12 months; 24 months; 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jul 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Arteriosclerosis ObliteransStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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
- 400 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zilun Li, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Zilun Li, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485622
- Sponsor's protocol ID
- [2024]225
- Status last verified
- Aug 2026
- First submitted
- 20 Jun 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scully RE, Arnaoutakis DJ, DeBord Smith A, Semel M, Nguyen LL. Estimated annual health care expenditures in individuals with peripheral arterial disease. J Vasc Surg. 2018 Feb;67(2):558-567. doi: 10.1016/j.jvs.2017.06.102. Epub 2017 Aug 25.
PubMed 28847660Fowkes FG, Aboyans V, Fowkes FJ, McDermott MM, Sampson UK, Criqui MH. Peripheral artery disease: epidemiology and global perspectives. Nat Rev Cardiol. 2017 Mar;14(3):156-170. doi: 10.1038/nrcardio.2016.179. Epub 2016 Nov 17.
PubMed 27853158Soga Y, Iida O, Takahara M, Hirano K, Suzuki K, Kawasaki D, Miyashita Y, Tsuchiya T. Two-year life expectancy in patients with critical limb ischemia. JACC Cardiovasc Interv. 2014 Dec;7(12):1444-9. doi: 10.1016/j.jcin.2014.06.018.
PubMed 25523536Gupta R, Siada S, Lai S, Al-Musawi M, Malgor EA, Jacobs DL, Malgor RD. Critical appraisal of the contemporary use of atherectomy to treat femoropopliteal atherosclerotic disease. J Vasc Surg. 2022 Feb;75(2):697-708.e9. doi: 10.1016/j.jvs.2021.07.106. Epub 2021 Jul 22.
PubMed 34303802Fu S, Zhao H, Shi J, Abzhanov A, Crawford K, Ohno-Machado L, Zhou J, Du Y, Kuo WP, Zhang J, Jiang M, Jin JG. Peripheral arterial occlusive disease: global gene expression analyses suggest a major role for immune and inflammatory responses. BMC Genomics. 2008 Aug 1;9:369. doi: 10.1186/1471-2164-9-369.
PubMed 18673543Folkersen L, Persson J, Ekstrand J, Agardh HE, Hansson GK, Gabrielsen A, Hedin U, Paulsson-Berne G. Prediction of ischemic events on the basis of transcriptomic and genomic profiling in patients undergoing carotid endarterectomy. Mol Med. 2012 May 9;18(1):669-75. doi: 10.2119/molmed.2011.00479.
PubMed 22371308
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans: a Prospective, Single-center, Observational Study
- ClinicalTrials.gov ID
- NCT06485622
- Acronym / sponsor ID
- [2024]225
- Conditions
- Arteriosclerosis Obliterans
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 3 Jul 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.
This study is a prospective, single-center, observational study. In this study, we aim to evaluate the clinical outcome and cost-effectiveness of different treatments of lower extremity arterial occlusive disease. It is expected to include about 400 patients diagnosed with lower extremity arterial occlusive disease in our center from July 2024 to July 2026. All enrolled patients will be followed for three years. All patients diagnosed with arteriosclerosis obliterans (ASO) and all treatment techniques were included in this study. The primary outcomes include the Efficacy and Safety End Points of each techniques.
Detailed description
Arteriosclerosis obliterans (ASO) is a kind of lower extremity arterial disease which occurs frequently in middle-aged and elderly people. The incidence of ASO increases with age. In patients with ASO, the build-up of fatty deposits, cholesterol, and other substances (plaques) in the arteries reduces blood flow to the extremities. This can lead to symptoms such as leg pain, cramping, and fatigue, especially during physical activity. In severe cases, it may result in pain at rest, non-healing wounds, and complications such as tissue damage or infection. Chronic wound is one of the symptoms that affect the quality of life. Therefore, wound healing is also an important index for postoperative care. However, no study has reported detailed performance data for different treatments. As an auxiliary method in clinical treatment, nutrition plays an important role in improving the clinical outcome of patients in the development and postoperative stages of the disease. The effect of nutritional risk assessment and nutritional education on postoperative symptoms of ASO has not been reported. Therefore, we plan to carry out this prospective, single-center, observational study, providing new data on the efficacy, safety and cost-effectiveness for different treatment and assistive techniques in lower extremity arterial occlusive disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Bypass group | – | Procedure: open bypass groupopen bypass group |
| BMS group | – | Procedure: bare metal stent groupBMS (bare metal stent) group |
| POBA group | – | Procedure: plain old balloon angioplasty groupPOBA (plain old balloon angioplasty) group |
| DCB group | – | Procedure: drug-coated balloon groupdrug-coated balloon group |
| DA group | – | Procedure: directional atherectomy groupDA (directional atherectomy) group |
| HR group | – | Procedure: hybrid repair groupHR (hybrid repair) group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- lower extremity arteriosclerosis obliterans
Key inclusion criteria (5 listed)
- Age 18 years or older, gender is not limited.
- Patients diagnosed with arteriosclerosis obliterans.
- Rutherford stages 2-6.
- When there are multiple stenosis lesions, the treatment of the most severe lesion is included.
- Patients with at least one arterial occlusion ( iliac, femoral, popliteal, anterior tibial, posterior tibial, and/or peroneal artery) of the lower extremity were included.
Key exclusion criteria (11 listed)
- Malignant tumor
- Alzheimer's disease
- Blood disease or bleeding tendency
- Heart Failure Grade III ~ IV
- Pregnancy or lactation
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 |
|---|---|---|
| open bypass groupAfter heparinization, the target artery is clamped above and below the anastomosis. The target artery is dissected along the anterior wall, calcium portions or mural thrombus are removed. Graft (autologous or prosthetic graft) is cut obliquely and anastomosis suturing starts with distal angle. Next stage is tunnel creating for graft conduction. | Procedure or surgery | Bypass group |
| bare metal stent groupBare metal stent implantation during the index procedure. | Procedure or surgery | BMS group |
| plain old balloon angioplasty groupOnly plain old balloon was used during the index procedure. | Procedure or surgery | POBA group |
| drug-coated balloon groupDrug-coated balloon was used during the index procedure. | Procedure or surgery | DCB group |
| directional atherectomy groupDirectional atherectomy (with or without drug-coated balloon) during the index procedure. | Procedure or surgery | DA group |
| hybrid repair groupFemoral artery arteriotomy. Further execute a direct endarterectomy femoral artery and from the mouth of a hip artery. Arteriotomy of the femoral artery is closed with a vascular patch use (synthetic or biological). Endovascular revascularization followed. | Procedure or surgery | HR group |
Primary outcome
Limb salvage rate
Time frame: 1 month; 6 months; 12 months; 24 months; 36 months
Freedom from above ankle amputation in target limb.
Primary patency rate
Time frame: 1 month; 6 months; 12 months; 24 months; 36 months
Primary patency of target lesion is assessed by the vascular ultrasound.
Major adverse limb event (MALE) rate
Time frame: 1 month; 6 months; 12 months; 24 months; 36 months
Major adverse limb events include anyone of the following: Amputation in target limb and major re-intervention on target limb.
All cause mortality rate
Time frame: 1 month; 6 months; 12 months; 24 months; 36 months
Death due to any cause.
4 secondary outcomes
Restenosis of the target lesion
Time frame: 1 month; 6 months; 12 months; 24 months; 36 months
Major adverse cardiovascular events (MACE)
Time frame: 1 month; 6 months; 12 months; 24 months; 36 months
Quality-adjusted life-years (QALYs)
Time frame: 1 month; 6 months; 12 months; 24 months; 36 months
Survival Rate
Time frame: 1 month; 6 months; 12 months; 24 months; 36 months
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 10 Sep 2026.
- Background: PubMed 28847660Scully RE, Arnaoutakis DJ, DeBord Smith A, Semel M, Nguyen LL. Estimated annual health care expenditures in individuals with peripheral arterial disease. J Vasc Surg. 2018 Feb;67(2):558-567. doi: 10.1016/j.jvs.2017.06.102. Epub 2017 Aug 25.
- Background: PubMed 27853158Fowkes FG, Aboyans V, Fowkes FJ, McDermott MM, Sampson UK, Criqui MH. Peripheral artery disease: epidemiology and global perspectives. Nat Rev Cardiol. 2017 Mar;14(3):156-170. doi: 10.1038/nrcardio.2016.179. Epub 2016 Nov 17.
- Background: PubMed 25523536Soga Y, Iida O, Takahara M, Hirano K, Suzuki K, Kawasaki D, Miyashita Y, Tsuchiya T. Two-year life expectancy in patients with critical limb ischemia. JACC Cardiovasc Interv. 2014 Dec;7(12):1444-9. doi: 10.1016/j.jcin.2014.06.018.
- Background: PubMed 34303802Gupta R, Siada S, Lai S, Al-Musawi M, Malgor EA, Jacobs DL, Malgor RD. Critical appraisal of the contemporary use of atherectomy to treat femoropopliteal atherosclerotic disease. J Vasc Surg. 2022 Feb;75(2):697-708.e9. doi: 10.1016/j.jvs.2021.07.106. Epub 2021 Jul 22.
- Background: PubMed 18673543Fu S, Zhao H, Shi J, Abzhanov A, Crawford K, Ohno-Machado L, Zhou J, Du Y, Kuo WP, Zhang J, Jiang M, Jin JG. Peripheral arterial occlusive disease: global gene expression analyses suggest a major role for immune and inflammatory responses. BMC Genomics. 2008 Aug 1;9:369. doi: 10.1186/1471-2164-9-369.
- Background: PubMed 22371308Folkersen L, Persson J, Ekstrand J, Agardh HE, Hansson GK, Gabrielsen A, Hedin U, Paulsson-Berne G. Prediction of ischemic events on the basis of transcriptomic and genomic profiling in patients undergoing carotid endarterectomy. Mol Med. 2012 May 9;18(1):669-75. doi: 10.2119/molmed.2011.00479.
- Individual participant dataSharing planned: No
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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.
Zilun Li principal investigator
First Affiliated Hospital, Sun Yat-Sen University
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 Arteriosclerosis Obliterans, run by First Affiliated Hospital, Sun Yat-Sen University 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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 Haoliang Wu (18738957806, wu18738957806@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb salvage rate (time frame: 1 month; 6 months; 12 months; 24 months; 36 months). The study lists 4 primary outcomes in all. 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 NCT06485622, which also lists 6 linked publications.
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 10 Sep 2026.