12-Month Results From the First-in-Human Randomized Study of the Ranger Paclitaxel-Coated Balloon for Femoropopliteal Treatment.
In: JACC: Cardiovascular Interventions, Jg. 11 (2018-05-28), Heft 10, S. 934-941
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Zugriff:
Objectives The authors sought to evaluate the performance of the Ranger paclitaxel-coated balloon versus uncoated balloon angioplasty for femoropopliteal lesions at 12 months. Background Drug-coated balloons (DCBs) are a promising endovascular treatment option for peripheral artery disease of the femoropopliteal segment, and each unique device requires dedicated clinical study. Methods The prospective, randomized RANGER SFA (Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries) study ( NCT02013193 ) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2 to 4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68 ± 8 years, n = 53 men) were enrolled in the Ranger DCB arm, and 34 patients (mean age 67 ± 9 years, n = 23 men) were assigned to the control group. Twelve-month analysis included patency, safety, and clinical outcomes and quality-of-life assessments. Results The DCB group had a greater primary patency rate at 12 months (Kaplan-Meier estimate 86.4% vs. 56.5%), with a significantly longer time to patency failure (log-rank p < 0.001). The estimated freedom from target lesion revascularization rate was 91.2% in the DCB group and 69.9% in the control group at 12 months, with a significantly longer time to reintervention (p = 0.010). No target limb amputations or device-related deaths occurred in either group. Conclusions Twelve-month results show that patency was maintained longer after Ranger DCB treatment than after conventional balloon angioplasty, and this result was associated with a low revascularization rate and good clinical outcomes. [ABSTRACT FROM AUTHOR]
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Titel: |
12-Month Results From the First-in-Human Randomized Study of the Ranger Paclitaxel-Coated Balloon for Femoropopliteal Treatment.
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Autor/in / Beteiligte Person: | Steiner, Sabine ; Willfort-Ehringer, Andrea ; Sievert, Horst ; Geist, Volker ; Lichtenberg, Michael ; Del Giudice, Costantino ; Sauguet, Antoine ; Diaz-Cartelle, Juan ; Marx, Claudia ; Ströbel, Armin ; Schult, Ingolf ; Scheinert, Dierk |
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Zeitschrift: | JACC: Cardiovascular Interventions, Jg. 11 (2018-05-28), Heft 10, S. 934-941 |
Veröffentlichung: | 2018 |
Medientyp: | academicJournal |
ISSN: | 1936-8798 (print) |
DOI: | 10.1016/j.jcin.2018.01.276 |
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