Excimer laser recanalization of femoropopliteal lesions and 1-year patency: results of the CELLO registry.
OBJECTIVE
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 >or=4.0 and <or=7.0 mm, and a total lesion length >or=1.0 and <or=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.


CONCLUSIONS
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.
Dave
Rajesh M
RM
Harrisburg Hospital, Harrisburg, Pennsylvania 17101, USA. rdintervention@yahoo.com
Patlola
Raghotham
R
Kollmeyer
Kenneth
K
Bunch
Frank
F
Weinstock
Barry S
BS
Dippel
Eric
E
Jaff
Michael R
MR
Popma
Jeffrey
J
Weissman
Neil
N
D000368:Aged; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000295:instrumentation*; D003251:Constriction, Pathologic; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology*; D006801:Humans; D054018:Lasers, Excimer; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology*; D011446:Prospective Studies; D011859:Radiography; D020127:Recovery of Function; D012042:Registries; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D018608:Ultrasonography, Doppler; D018084:Ultrasonography, Interventional; D014481:United States; D014654:Vascular Patency; D016138:Walking