NCT06485622 Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans
| NCT ID | NCT06485622 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University |
| Condition | Arteriosclerosis Obliterans |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2024-07-01 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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
Contact & Investigator
Zilun Li
PRINCIPAL INVESTIGATOR
First Affiliated Hospital, Sun Yat-Sen University
Frequently Asked Questions
Who can join the NCT06485622 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Arteriosclerosis Obliterans. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06485622 currently recruiting?
Yes, NCT06485622 is actively recruiting participants. Contact the research team at wu18738957806@126.com for enrollment information.
Where is the NCT06485622 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06485622 clinical trial?
NCT06485622 is sponsored by First Affiliated Hospital, Sun Yat-Sen University. The principal investigator is Zilun Li at First Affiliated Hospital, Sun Yat-Sen University. The trial plans to enroll 400 participants.