Skip to main content
. 2020 Sep 29;2020(9):CD006680. doi: 10.1002/14651858.CD006680.pub3

NCT01763476.

Study name Atherectomy and drug‐coated balloon angioplasty in treatment of long infrapopliteal lesions (ADCAT)
Methods Prospective, open, randomised, parallel assignment, single‐centre clinical trial
Participants Estimated enrolment: 80 participants
Ages eligible for study: 50 years to 85 years
Inclusion criteria:

  1. participant must be between 50 and 85 years old;

  2. women of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12‐month angiographic evaluation;

  3. clinical diagnosis of symptomatic critical limb ischaemia as defined by Rutherford 3, 4, or 5;

  4. single treatment of de novo lesion(s) in the tibioperoneal trunk, anterior, posterior or peroneal artery with a lesion length ≥ 6 cm;

  5. one vessel in one limb may be treated in the study. Additional non‐target lesion(s) in remaining non‐target vessel(s) can be treated at the physician's discretion by means of balloon dilation or stent placement;

  6. the total length of target lesion(s) can be a maximum of 250 mm;

  7. in total, a maximum of four drug‐coated balloons may be used to fully cover the target lesion;

  8. target vessel is between 2.0 and 3.5 mm in diameter (visual estimate);

  9. target lesion stenosis is > 70% diameter stenosis (visual estimate);

  10. guidewire must be across the target lesion and located intraluminally within the distal outflow vessel before study randomisation;

  11. interventions in TASC A and B lesions to restore adequate blood flow, in the same index procedure are allowed. This intervention must be prior to the treatment of the study lesion(s) and successful;

  12. willing to comply with the specified follow‐up evaluation;

  13. written informed consent prior to any study procedures.


Exclusion criteria:

  1. significant (> 50%) stenoses distal to the target lesion (dorsalis pedis artery, plantar arch) that might require revascularisation, or impede runoff;

  2. angiographic evidence of thrombus within target vessel;

  3. thrombolysis within 72 hours prior to the index procedure;

  4. in‐stent restenosis or restenosis of a native artery;

  5. aneurysm in the femoral artery or popliteal artery;

  6. concomitant hepatic insufficiency, thrombophlebitis, DVT, coagulation disorder or receiving immunosuppressant therapy;

  7. recent myocardial infarction or stroke < 30 days prior to the index procedure;

  8. life expectancy less than 12 months;

  9. known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb;

  10. known or suspected allergies or contraindications to aspirin, clopidogrel bisulphate (Plavix) and ticlopidine (Ticlid), heparin, or contrast agent;

  11. any significant medical condition which, in the investigator's opinion, may interfere with the person's optimal participation in the study;

  12. the person is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
Interventions Arm 1: paclitaxel‐coated balloon angioplasty
Arm 2: atherectomy + paclitaxel‐balloon
Outcomes Primary outcome measure: primary patency of the target lesion 6 months after index procedure measured by duplex ultrasound (PVR > 2.4) and angiography (core lab analysis).
Secondary outcome measure: need for TLR from baseline to 6 months after index procedure.
Other outcome measures: change in Rutherford‐Becker Class from baseline to 6 and 12 months after index procedure.
Starting date January 2013
Contact information Aljoscha Rastan, M.D., Herz‐Zentrums Bad Krozingen
Notes