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

NCT02517827.

Study name Percutaneous intervention versus surgery in the treatment of common femoral artery lesions (PESTO‐AFC)
Methods Prospective, open, randomised, parallel assignment, multi‐centre clinical trial
Participants Estimated enrolment; 306 participants
Inclusion criteria:

  1. between 21 and 85 years old;

  2. female 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 peripheral artery disease defined by Rutherford 2, 3, or 4;

  4. CFA stenosis (including CFA bifurcation) > 70% (visual estimate) or occlusion; Additional non‐target lesion(s) in remaining non‐target vessel(s), except ipsilateral iliac arteries, can be treated at the physician´s discretion;

  5. at least one vessel outflow (infrapopliteal arteries) to the foot (without stenosis > 50%).

  6. endovascular procedure: successful target lesion crossing of the guidewire (guidewire located intraluminally);

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

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

  9. written informed consent prior to any study procedures.


Exclusion criteria:

  1. ipsilateral significant (> 50%) stenosis of the iliac arteries;

  2. significant (> 50%) stenosis of all infrapopliteal arteries, no patent artery to the foot;

  3. angiographic evidence of thrombus within target vessel;

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

  5. in‐stent restenosis or restenosis of the native common femoral artery;

  6. aneurysm in the abdominal aorta or iliac arteries;

  7. concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy;

  8. recent MI or stroke < 30 days prior to the index procedure;

  9. life expectancy less than 24 months;

  10. known or suspected active infection at the time of the index procedure;

  11. known or suspected allergies or contraindications to aspirin, clopidogrel bisulphate and ticlopidine, heparin, or contrast agent;

  12. any significant medical condition which, in the investigator´s opinion, may interfere with the subject´s optimal participation in the study;

  13. 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 Intervention/treatment
Active comparator: endovascular procedure
Common femoral artery (target lesion) to be treated with directional atherectomy and paclitaxel‐coated balloon angioplasty. Optional: stent implantation.
Device: Atherectomy and paclitaxel‐coated balloon angioplasty
Directional atherectomy and paclitaxel‐coated balloon angioplasty (optional with stent implantation) of the CFA
Active comparator: surgery
CFA (target lesion) to be treated with open, surgical endarterectomy
Procedure: open, surgical endarterectomy of the CFA
Outcomes Primary outcome measure:
Primary patency (12 months): primary patency of the CFA defined as freedom from target lesion restenosis (luminal narrowing of ≥ 50%) detected with duplex‐ultrasound. The definition of a 50% restenosis is based on the peak systolic velocity ratio > 2.4.
Secondary outcome measures:

  1. Primary patency (24 months): defined as above

  2. TLR (6, 12, and 24 month): need for TLR after index procedure


Other outcome measures:
Rutherford‐Becker class (6, 12, and 24 months): change in Rutherford‐Becker class
Starting date 1 August 2017
Contact information Contact: Aljoscha Rastan, MD
Contact: Thomas Zeller, MD
Notes