Status:
UNKNOWN
Study of DA+LDD in the Treatment of Femoropopliteal Occlusive Disease
Lead Sponsor:
RenJi Hospital
Conditions:
Peripheral Artery Disease
Endovascular Treatment
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study will evaluate the effectiveness and safety of directional atherectomy plus local drug delivery using balloon catheter system in the treatment of femoropopliteal occlusive disease. Patients ...
Detailed Description
Femoropopliteal occlusive disease is a common type of peripheral arterial disease. Endovascular treatment has been the first-line treatment of femoropopliteal occlusive disease. However, the in-stent ...
Eligibility Criteria
Inclusion
- age of 18-80 years old
- patients of femoropopliteal occlusive disease (Rutherford 2-4)
- length of lesion ≤ 20cm
- have signed the informed consent
Exclusion
- serum Cr \> 150 umol/L
- patients with acute thrombosis
- received endovascular treatment for femoropopliteal disease in recent 6 months
- less than 1 run-off vessel
- allergic to aspirin, heparin, clopidogrel, paclitaxel, contrast medium
- pregnancy and lactation
- relatively easy bleeding
- malignancy or irreversible organ failure
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03380650
Start Date
January 1 2018
End Date
December 30 2019
Last Update
December 21 2017
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