Authors
Michael Haude, Hüseyin Ince, Alexandre Abizaid, Ralph Toelg, Pedro Alves Lemos, Clemens Von Birgelen, Evald Høj Christiansen, William Wijns, Franz-Josef Neumann, Christoph Kaiser, Eric Eeckhout, Soo Teik Lim, Javier Escaned, Hector M Garcia-Garcia, Ron Waksman
Publication date
2016/1/2
Journal
The Lancet
Volume
387
Issue
10013
Pages
31-39
Publisher
Elsevier
Description
Background
Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions.
Methods
We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2·2 mm and 3·7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 …
Total citations
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