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. 2020 Sep 29;2020(9):CD006680. doi: 10.1002/14651858.CD006680.pub3

NCT02840786.

Study name Clinical study of stent versus direct atherectomy to treat arteriosclerosis occlusive disease of lower extremity
Methods Open, randomised, parallel assignment clinical trial
Participants Estimated enrolment: 221 participants
Inclusion criteria:
Patients were included if they were de novo stenosis > 70% or occlusion of the femoropopliteal at least 18 years of age and referred for claudication (Rutherford‐Becker class II‐III) or critical limb ischaemia (Rutherford‐Becker class IV‐V).
Exclusion criteria:

  1. acute or subacute lower limb ischaemia;

  2. severe calcification lesions;

  3. total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalisation;

  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. platelet count is less than 100,000/uL, antiplatelet or anticoagulant contraindications to required medications;

  8. 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.
Interventions Arm 1: stent
Arm 2: direct atherectomy
Outcomes Primary outcome measure:
12‐month primary patency rate (12 months) (systolic velocity ratio > 2.4 as measured by Duplex ultrasound)
Secondary outcome measures:

  1. technical success defined as residual stenosis less than 30% by final angiography and/or a flow‐limiting dissection (1 day);

  2. freedom from clinically‐driven TLR defined as the freedom from clinically‐driven TLR (12 months);

  3. MAE at 12‐months postprocedure. MAEs included death, index limb ischaemia, index limb amputation, clinically driven target lesion revascularisation, and significant embolic events, which were defined as causing end‐organ damage;

  4. 12‐month limb salvage rate defined as the freedom from secondary major amputation.
Starting date 21 July 2016
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Notes