An interventional study of plaque excision system and stent in Atherosclerosis and In-stent Arterial Restenosis, sponsored by Xuanwu Hospital, Beijing. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-04.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment
This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery).
This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery).
1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.
This study's planned enrollment of 120 is above the median of 106 across 882 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Provides written informed consent Willing to comply with follow-up evaluations at specified times Has claudication or rest pain due to peripheral arterial In-stent restenosis Disease located within the femoropopliteal artery Patient has a In-stent restenosis lesion(s) with >50% stenosis documented angiographically Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.
Exclusion Criteria:
They were excluded if they had one or more of the following: 1. Acute or subacute lower limb ischemia; 2. Severe calcification lesions; 3. Total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization 4. untreated ipsilateral iliac artery stenosis>70%, or the distal runoff artery \<1 root; 5. Previously lower extremity intervention or surgical graft artery bypass; 6. Severe renal insufficiency, creatinine level greater than 2.5 mg/dL; 7. The patient's platelet count is less than 100,000/uL, antiplatelet or anticoagulant contraindications to required medications; 8. Patients with immune system diseases or malignant tumours; 9. ongoing active infection 10. decompensated congestive heart failure or acute coronary syndrome; 11. Unwillingness to return for future follow-up visits
Stents group
Device: stent
Direct Atherectomy group
Device: plaque excision system
Balloon group
Device: Balloon
Primary Patency Rate
Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis \>50% with a peak systolic velocity ratio \>2.4 as measured by Duplex ultrasound.
Time frame: 12 months
Technical success
Technical success is defined as residual stenosis less than 30% by final angiography and/or a flow-limiting dissection.
Time frame: 1 day
freedom from clinically-driven TLR
it is defined as freedom from clinically-driven target lesion revascularization
Time frame: 12 months
Major Adverse Events
Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization, and significant embolic events, which were defined as causing end-organ damage.
Time frame: 12 months
Limb Salvage Rate
Limb Salvage is defined as the freedom from secondary major amputation
Time frame: 12 months
Plan to share: Yes
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Xuanwu Hospital, Beijing