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

被引:63
作者
Dave, Rajesh M. [1 ]
Patlola, Raghotham [2 ]
Kollmeyer, Kenneth [4 ]
Bunch, Frank [3 ]
Weinstock, Barry S. [5 ]
Dippel, Eric [6 ]
Jaff, Michael R. [7 ]
Popma, Jeffrey [8 ]
Weissman, Neil [9 ]
机构
[1] Harrisburg Hosp, Pinnacle Hlth Heart & Vasc Inst, Harrisburg, PA 17101 USA
[2] SW Med Ctr, Lafayette, LA USA
[3] Thomas Hosp, Fairhope, AL USA
[4] Methodist Med Ctr, Dallas, TX USA
[5] Orlando Reg Med Ctr Inc, Orlando, FL USA
[6] Midwest Cardiovasc Res Fdn, Davenport, IA USA
[7] Massachusetts Gen Hosp, Boston, MA 02114 USA
[8] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA
[9] MedStar Res Inst, Washington, DC USA
关键词
peripheral artery disease; superficial femoral artery; popliteal artery; atherectomy; balloon angioplasty; stenting; Walking Impairment Questionnaire; SUPERFICIAL FEMORAL-ARTERY; ANGIOPLASTY; STENTS;
D O I
10.1583/09-2781.1
中图分类号
R61 [外科手术学];
学科分类号
摘要
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. J Endovasc Ther. 2009;16:665-675
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收藏
页码:665 / 675
页数:11
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