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A Journal on Heart and Vascular Diseases

Official Journal of the Italian Society of Angiology and Vascular Pathology
Indexed/Abstracted in: EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
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Minerva Cardioangiologica 2010 October;58(5):583-88

language: English

Treatment of coronary in-stent restenosis with a novel paclitaxel urea coated balloon

Cremers B. 1, Clever Y. 1, Schaffner S. 2, Speck U. 3, Böhm M. 1, Scheller B. 1

1 Clinic of Internal Medicine III, Saarland University Hospital, Homburg/Saar, Germany;
2 Invatec Technology Center, Frauenfeld, Switzerland;
3 Radiology, Charité, Humbold University of Berlin, Berlin, Germany


Randomized clinical trials investigating the treatment of coronary in-stent restenosis with paclitaxel iopromide coated balloon catheters have shown favorable results. The aim of the present clinical investigation was to assess the efficacy of a novel paclitaxel urea coated angioplasty balloon in the treatment of coronary in-stent restenosis. A total of 26 restenotic bare metal stents in 23 patients with a lesion length of 22.8±11.1 mm and a reference vessel diameter of 2.64±0.31 mm were treated. Up to six months and including the six-month angiographic control, only one target lesion revascularization was necessary; in total, the rate of major adverse cardiovascular events until six-month follow-up was 4.3 %. In-stent late lumen loss was 0.07±0.37 mm, in-segment late lumen loss 0.02±0.50 mm. Binary restenosis was present in one patient (4.3%). The results of this first-in-human series with a paclitaxel urea coated balloon are comparable to paclitaxel iopromide coated balloon catheters. Randomized, controlled clinical trials are warranted to further evaluate this promising approach.

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