Excimer Laser Recanalization of Femoropopliteal Lesions and 1-Year Patency: Results of the CELLO Registry

Abstract

Purpose:

To evaluate the safety and efficacy of a modified laser catheter designed for the endovascular treatment of peripheral artery disease (PAD) affecting the superficial femoral artery (SFA) and proximal popliteal artery.

Methods:

The CliRpath Excimer Laser System to Enlarge Lumen Openings (CELLO) study was a single-arm, prospective registry conducted at 17 investigational sites in the United States. The primary endpoint was the reduction in index lesion percent diameter stenosis (% DS) measured by Doppler ultrasound following laser ablation prior to any adjunctive therapy. The primary safety endpoint was major adverse events at 6 months. Sixty-five patients (39 men; mean age 68.3±10.1 years) with intermittent claudication, stenotic lesions >70% by visual assessment, a reference vessel diameter ≥4.0 and ≤7.0 mm, and a total lesion length ≥1.0 and ≤15.0 cm underwent laser-assisted recanalization with optional balloon angioplasty (BA) or BA + stenting. Sixty-five de novo lesions (5.6±4.7 cm) in 13 occluded and 52 stenotic arteries were treated.

Results:

Laser ablation reduced the % DS from 77%±15% at baseline to 34.7%±17.8%, which was reduced to 21%±14.5% after adjunctive therapy with BA (n=42, 64.6%) or BA + stenting (n=15, 23.3%). Eight (12.3%) patients did not receive post laser adjunctive therapy. Patency rates (% DS <50%) were 59% and 54% at 6 and 12 months, respectively. Target lesion revascularization was not required in 76.9% of CELLO participants within the 1-year follow-up. There were no major adverse events. The study cohort demonstrated a statistically significant improvement in the walking impairment and functional status assessments during follow-up.

Conclusion:

The data validate the safety and efficacy of the investigational device, with a high clinical success rate and 12-month data indicating freedom from reintervention in the majority of patients treated.