Multiple stent delivery system “Multi-LOC”: focal self-expanding nitinol stenting of complex femoropopliteal lesions - a monocenter feasibility pilot study
Aims: The Multiple Stent Delivery System (VascuFlex® Multi-LOC) is a novel stent delivery system with six short stents (13 mm long each) mounted on one wire-guided catheter, designed for the treatment of femoropopliteal arteries. The aim of the present study is to evaluate the safety and the feasibi...
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
January 3, 2019
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JRSM Cardiovascular disease
Year: 2019, Jahrgang: 8 |
| ISSN: | 2048-0040 |
| DOI: | 10.1177/2048004018822618 |
| Online-Zugang: | Verlag, kostenfrei, Volltext: http://dx.doi.org/10.1177/2048004018822618 Verlag, kostenfrei, Volltext: https://doi.org/10.1177/2048004018822618 
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| Verfasserangaben: | Martin Sigl, Johannes Jung, Heinz Kölble and Klaus Amendt |
| Zusammenfassung: | Aims: The Multiple Stent Delivery System (VascuFlex® Multi-LOC) is a novel stent delivery system with six short stents (13 mm long each) mounted on one wire-guided catheter, designed for the treatment of femoropopliteal arteries. The aim of the present study is to evaluate the safety and the feasibility of the VascuFlex® "Multi-LOC" stent delivery system, which enables spot stenting without changing the delivery system. Methods and results: After proof of concept in a porcine model and after European Conformity marking, first clinical experiences were gathered in 20 patients with severe intermittent claudication or critical limb ischemia. First-in-human data are presented. The study included 20 limbs that underwent femoropopliteal revascularization for claudication (n = 14) or critical limb ischemia (n = 6). "Multi-LOC" provisional spot stenting resulted in acute technical success in all lesions with resolution of flow-limiting dissection and elastic recoil after balloon dilatation of the femoropopliteal artery. There were no device-related complications. Follow-up examinations after 30 to 40 days revealed no major adverse events, and six months' results were encouraging. Conclusions: First clinical use of the novel Multiple Stent Delivery System (Multi-LOC) after balloon dilatation of the femoropopliteal artery was safe and feasible in this early study. |
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| Beschreibung: | Gesehen am 06.03.2019 |
| Beschreibung: | Online Resource |
| ISSN: | 2048-0040 |
| DOI: | 10.1177/2048004018822618 |