Evaluating treatments for arteriosclerosis obliterans
Official title: Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans: a Prospective, Single-center, Observational Study
Run by First Affiliated Hospital, Sun Yat-Sen University · NCT06485622 · Data updated 2026-11-12
This study is testing different treatments for arteriosclerosis obliterans to see which ones work best and are most cost-effective for people with this condition.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | July 2027 |
| Study ends | July 2029 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT06485622 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older diagnosed with arteriosclerosis obliterans at various Rutherford stages.
✕Probably not a fit
Patients with severe comorbidities, such as advanced heart failure or malignancies, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the clinical outcomes and cost-effectiveness of various treatments for lower extremity arterial occlusive disease, specifically arteriosclerosis obliterans. It will enroll approximately 400 patients diagnosed with this condition from July 2024 to July 2026, following them for three years. The study will evaluate the efficacy and safety of different treatment techniques, including open bypass, stenting, balloon angioplasty, and atherectomy, while also considering the role of nutritional support in patient recovery.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the most effective treatment options for patients with arteriosclerosis obliterans, potentially improving their quality of life.
How similar studies have gone: While there have been studies on treatments for lower extremity arterial disease, this specific approach focusing on a comprehensive evaluation of multiple treatment modalities and nutritional support is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years or older, gender is not limited. 2. Patients diagnosed with arteriosclerosis obliterans. 3. Rutherford stages 2-6. 4. When there are multiple stenosis lesions, the treatment of the most severe lesion is included. 5. Patients with at least one arterial occlusion ( iliac, femoral, popliteal, anterior tibial, posterior tibial, and/or peroneal artery) of the lower extremity were included. Exclusion Criteria: 1. Malignant tumor 2. Alzheimer's disease 3. Blood disease or bleeding tendency 4. Heart Failure Grade III \~ IV 5. Pregnancy or lactation 6. An above-knee-below-knee amputation has been performed 7. Unable to accept therapeutic function tests 8. Life expectancy is less than six months 9. Combined with other diseases affecting walking 10. Cardiovascular and cerebrovascular events occurred within 3 months, including non-fatal myocardial infarction, unstable angina, stable angina, non-fatal ischemic stroke and hemorrhagic stroke 11. Patients with significant abnormal liver and renal function that the investigators judged to be clinically significant
Where it's running
-
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: Zilun Li — First Affiliated Hospital, Sun Yat-Sen University
- Study coordinator: Haoliang Wu
- Email: wu18738957806@126.com
- Phone: 18738957806
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.