An interventional study of drug eluting balloon catheter (trade name: Orchid) and common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral) in Peripheral Artery Disease, sponsored by Acotec Scientific Co., Ltd. Completed at 10 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-07-12.
Sponsored by Acotec Scientific Co., Ltd · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether DEB is more effective than common PTA balloon in long-term vessel patency and inhibiting restenosis.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 200 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Acotec Scientific Co., Ltd is the lead sponsor of 17 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
use drug eluting balloon catheter to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
Device: drug eluting balloon catheter (trade name: Orchid)
use common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery
Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)
Also known as: drug eluting dilation catheter
Also known as: common PTA catheter
Late Lumen Loss
measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months
Time frame: 6 months
Minimal lumen diameter (MLD)
measure minimal lumen diameter (MLD) of target lesion
Time frame: 6 months
Restenosis rate of target vessel
stenosis over 50% is defined as restenosis
Time frame: 6 months, 12 months, 18 months, 24months
target lesion revascularization
target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
Time frame: 6 months, 12 months, 18 months, 24 months
change in Rutherford stage
based the following definition of Rutherford stage, evaluate the stage of patient. Then compare the stage of patient just after procedure and 6 months after treatment Stage clinical symptom 0 asymptomatic 1. mild claudication 2. moderate claudication 3. severe claudication 4. ischemic rest pain 5. minor tissue loss 6. ulceration or gangrene
Time frame: 6 months, 12 months, 18 months, 24 months
change in ankle brachial index(ABI)
change in ankle brachial index(ABI) compared to pretreatment
Time frame: 6 months
major amputation
major amputation at the index limb(major amputation is defined as an amputation above the foot)
Time frame: 6 months, 12 months, 18 months, 24 months
Death
death of any cause
Time frame: 12 months, 18 months, 24 months
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Acotec Scientific Co., Ltd