Use of a self-expanding super-elastic all-metal endoprosthesis; To treat degenerated SVG lesions: The SESAME first in man trial

Alexander Abizaid, Bonnie Weiner, Steven R. Bailey, Hugo Londero

Research output: Contribution to journalArticlepeer-review

14 Scopus citations

Abstract

We prospectively evaluated a novel nano-synthesized, membrane-covered self-expanding super-elastic all-metal endoprosthesis stent (SESAME Stent™) in patients undergoing percutaneous intervention (PCI) of degenerated saphenous vein graft (SVG) lesions. Methods: SESAME investigators prospectively enrolled 20 patients/21 lesions at 2 outside United States (OUS) centers, between February 2005 and August 2005. Patients underwent elective intervention of symptomatic SVG lesions with ≥50% stenosis. PCI was performed without embolic protection devices. The primary end point was technical and procedural success. Secondary end points included major adverse cardiac events (MACE) at 30 days and 9 months. Results: Twenty patients (twenty-one SVG lesions) received SESAME stents. The acute success was 100%. No procedural or in hospital complications occurred. One patient underwent a planned staged PCI at 28 days in a separate SVG. Follow-up was present in 20 patients at 30 days, with clinical (n = 19) and angiographic evaluation (18 patients/19 lesions) at 9 months. No MACE events occurred at 30 days. At 9 months, 3 patients underwent repeat PCI. One TLR (restenosis at the overlap of two stents) and two nonindex lesion TVR for a MACE rate of 14% at 9 months. Conclusions: This study demonstrated the ABPS SESAME Stent™ has excellent acute success, low 30 day MACE rates and 9 month patency of the SESAME is similar to balloon expandable stents without embolic protection.

Original languageEnglish (US)
Pages (from-to)781-786
Number of pages6
JournalCatheterization and Cardiovascular Interventions
Volume76
Issue number6
DOIs
StatePublished - Nov 15 2010

Keywords

  • complications
  • devices
  • embolic protection
  • percutaneous coronary intervention
  • saphenous vein graft
  • thrombosis

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Fingerprint Dive into the research topics of 'Use of a self-expanding super-elastic all-metal endoprosthesis; To treat degenerated SVG lesions: The SESAME first in man trial'. Together they form a unique fingerprint.

Cite this