Experimental and clinical evaluation of the PARIS centering catheter for delivery of endovascular gamma-irradiation of femoropopliteal stenoses.

PURPOSE: To investigate the effect of aortic bifurcation and iliac geometry on centered endovascular irradiation (CEI) of femoropopliteal arteries and evaluate procedure-related complications.
MATERIALS AND METHODS: In an experimental tubing model, crossover delivery of the dummy wire by an afterloader using different sheaths (Type I: noncrossover; Type II: crossover, length 40 cm; Type III: crossover, length 65 cm) was examined at simulated angles between 20 degrees -100 degrees (aortic bifurcation) and 0 degrees -100 degrees (iliac vessels). In the clinical phase, 28 heparin-anticoagulated patients underwent percutaneous transluminal angioplasty (PTA) for femoropopliteal stenoses followed by CEI (192-iridium, 14 Gray at 2 mm depth of the vessel wall) delivered with the centering catheter (crossover from contralateral leg using a 65-cm-long 8F sheath in 13 patients, noncrossover from ipsilateral leg using a 10-cm 8F sheath in 15 patients). Measurement of the aortic bifurcation angle before advancement of the crossover sheath and rating of iliac artery tortuosity on both sides was retrospectively performed on angiograms. Fifteen controls received no post-PTA CEI.
RESULTS: Experimental delivery of the dummy wire was not possible at aortic angles less than 40 degrees with Type I, 60 degrees with Type II, and 30 degrees with Type III sheaths. Advancement of the centering catheter was possible in all patients. CEI failed in two patients with crossover (aortic angle <40 degrees ) and in one obese patient with antegrade approach because advancement of the dummy wire was impossible. Thromboembolism rate was 4.6% during irradiation (2.3% after PTA alone).
CONCLUSIONS: CEI in femoropopliteal arteries has a risk of procedure-related thromboembolic complications. Efficacy is affected by vessel geometry.