Status:
UNKNOWN
Outcome of Endovascular Therapies in Chronic Femoropopliteal Occlusive Disease With Severe Calcification
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Conditions:
Femoropopliteal Artery Occlusion
Eligibility:
All Genders
18+ years
Brief Summary
This study is a prospective, multicenter, real world, observational study, which aims at evaluating the safety, efficacy and economic cost of endovascular treatments for endovascular therapies in chro...
Detailed Description
Arteriosclerosis obliterans (ASO) is a common disease in middle-aged and elderly people, which affects up to 30% people who are over 70 years in the general population. Its symptoms include claudicati...
Eligibility Criteria
Inclusion
- Rutherford stages 2-6
- The target vessel (femoral and/or popliteal artery) has at least ≥90% stenosis or occlusion with the moderate to severe calcification (defined as \>5 cm continuous calcification)
- For patients with both lower limbs to be treated, the side with severer calcification is selected. If the calcification is similar in the two sides, the first one to be treated is selected.
- At least one outflow artery (which is patent in \> 1/3 length) in the calf connects the popliteal artery.
- Patients who failed the first treatment because the guide wire could not pass through the lesion can still be selected if the second endovascular treatment succeeds.
- There is no restriction on the types of endovascular techniques and devices.
Exclusion
Key Trial Info
Start Date :
December 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04716361
Start Date
December 10 2020
End Date
December 31 2024
Last Update
February 22 2023
Active Locations (1)
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1
The First Affliated Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China, 310000