NCT05391815 This Study is a Prospective, Multi-center, Real World, Observational Study, Which Aims at Evaluating Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease.
| NCT ID | NCT05391815 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Peripheral Arterial Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2027-06-01 |
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 800 participants in total. It began in 2021-04-01 with a primary completion date of 2027-06-01.
⚠ 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, multi-center, real world, observational study, which aims at evaluating the intermediate and long-term efficacy of endovascular treatment for TASC C\&D aortoiliac occlusive disease .It is estimated that 800 subjects diagnosed with TASC C\&D aortoiliac occlusive disease and receive endovascular treatments will be enrolled in nine centers from April 2021 to June 2027 nation-widely. All the subjects will be under follow-up for 60 months. There is no restriction on the endovascular techniques. The primary outcomes covers freedom from TLR at 60 months.
Eligibility Criteria
Inclusion Criteria: 1. Rutherford grades 3-6. 2. Follow the follow-up arrangement. 3. Age: 18-80 years old. 4. The target lesions were in the lower abdominal aorta and/or the common iliac artery and/or the external iliac artery. 5. The stenosis degree ≥50%, or restenosis (received PTA or other adjuvant therapy, including bare or covers stents), or complete occlusion, or the presence of aortailiac artery thrombosis after PMT or CDT thrombus clearance, and then further endovascular therapy perfomred. 6. Signed informed consent. Exclusion Criteria: 1. Known allergy to drugs used in this study, including antiplatelet or anticoagulant drugs, etc. 2. Allergy to iodine contrast agent allergy; 3. Coagulation dysfunction or hypercoagulability; 4. Breast-feeding or pregnant women; 5. Life expectancy \< 24 months; 6. Body condition can not tolerate endovascular treatment; 7. Type 2B, type 3 lower limb ischemia patients
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05391815 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05391815 currently recruiting?
Yes, NCT05391815 is actively recruiting participants. Contact the research team at shizhenyumax@163.com for enrollment information.
Where is the NCT05391815 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05391815 clinical trial?
NCT05391815 is sponsored by Shanghai Zhongshan Hospital. The trial plans to enroll 800 participants.