Clinical Trial: ACROSS-Cypher Total Occlusion Study of Coronary Arteries 4 Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Approaches to Chronic Occlusions With Sirolimus Stents-Cypher (ACROSS-Cypher) Total Occlusion Study of Coronary Arteries 4 Trial

Brief Summary: ACROSS-Cypher® is a prospective, multi-center, open label, single arm study of the Cypher® sirolimus eluting coronary stent in native total coronary occlusion revascularization. The primary endpoint is binary angiographic restenosis at 6 months. The TOSCA-1 trial will be used as the historical control. The hypothesis is that compared with TOSCA-1 patients who were treated with the heparin-coated Palmaz Schatz stent, treatment with the Cypher® sirolimus eluting coronary stent will result in a >50% relative reduction in 6 month restenosis within the treated segment of the target vessel.

Detailed Summary:

Despite remarkable advances in the procedural and clinical outcomes of percutaneous revascularization, chronically occluded coronary arteries remain a formidable challenge and unresolved dilemma in interventional cardiology. Although a TCO is identified in approximately one-third of diagnostic cardiac catheterizations, still an attempted revascularization accounts for less than 8% of all percutaneous coronary interventions (PCI). Such a disparity between their frequency and treatment not only underscores the technical and procedural frustrations associated with these complex lesions, but also the clinical uncertainties regarding clinical benefits with conventional TCO revascularization and the ongoing inadequacies of current PCI methods for sustaining restenosis-free patency following initial success.

Until recently, few clinical investigations have been performed to support clinical benefit of TCO revascularization. In addition to relief of symptomatic ischemia, theoretical advantages have included enhanced left ventricular function, reduced predisposition to arrhythmic events, and improved tolerance of future ischemic events. In the Survival and Ventricular Enlargement (SAVE) trial, persistent occlusion of the infarct-related artery was associated with a relative risk of 1.47 in adjusted 4-year mortality (P=0.04). Since then, a limited number of studies documenting long-term outcomes following intended TCO revascularization have been performed.

This investigational protocol is designed to evaluate the safety and efficacy of the Cypher® sirolimus eluting coronary stent (Cordis Corporation, Miami Lakes, FL) in patients undergoing elective revascularization of nonacute total coronary occlusions (TCO). Specifically, approximately 200 patients will undergo Cypher® sirolimus eluting coronary stent(s) implantation fol
Sponsor: Sunil Rao

Current Primary Outcome: Angiographic binary restenosis (>=50% diameter stenosis) in TCO treated/working length compared with restenosis outcomes in the Total Occlusion Study of Canada (TOSCA) [ Time Frame: 6 months post-procedure ]

Original Primary Outcome: • Angiographic binary restenosis (> 50% diameter stenosis) in total chronic occlusions treated/working length compared with restenosis outcomes in the Total Occlusion Study of Canada (TOSCA)

Current Secondary Outcome:

  • Angiographic binary in-segment restenosis (>= 50% diameter stenosis) rate at 6 months post-procedure [ Time Frame: 6 months post-procedure ]
  • Angiographic binary in-stent restenosis (>= 50% diameter stenosis) rate at 6 months post-procedure [ Time Frame: 6 months post-procedure ]
  • In-segment late lumen loss at 6 months [ Time Frame: 6 months post-procedure ]
  • In-stent late lumen loss at 6 months [ Time Frame: 6 months post-procedure ]
  • Device Success [ Time Frame: 6 months post-procedure ]
  • Lesion Success [ Time Frame: 6 months post-procedure ]
  • Procedure Success [ Time Frame: 6 months post-procedure ]
  • Major Adverse Cardiac Events (MACE) rate at 30 days, 6 months, and 12 months post-procedure [ Time Frame: 30 days, 6 months and 12 months post-procedure ]
  • Target Site Revascularization (TSR) rate and clinically-driven TSR rate at 6 and 12 months post-procedure Target Vessel Revascularization (TVR) rate and clinically-driven TVR rate at 6 and 12 months post-procedure [ Time Frame: 6 and 12 months post-procedure ]
  • Target Vessel Failure (TVF) rate at 6 and 12 months post-procedure [ Time Frame: 6 and 12 months post-procedure ]
  • In-stent and in-segment minimum lumen diameter (MLD) at 6 months post-procedure [ Time Frame: 6 months post-procedure ]
  • Failure of sustained patency at 6 months (≥70% stenosis with TIMI <3 flow at follow-up angiography) [ Time Frame: 6 months post-procedure ]
  • Subacute thrombosis occurring within 30 days post-procedure [ Time Frame: 30 days post-procedure ]


Original Secondary Outcome:

  • Angiographic binary in-segment restenosis (> 50% diameter stenosis) rate at 6 months post-procedure
  • Angiographic binary in-stent restenosis (> 50% diameter stenosis) rate at 6 months post-procedure
  • In-segment late lumen loss at 6 months
  • In-stent late lumen loss at 6 months
  • Device Success
  • Lesion Success
  • Procedure Success
  • Major Adverse Cardiac Events (MACE) rate at 30 days, 6 months, and 12 months post-procedure
  • Target Site Revascularization (TSR) rate and clinically-driven TSR rate at 6 and 12 months post-procedure Target Vessel Revascularization (TVR) rate and clinically-driven TVR rate at 6 and 12 months post-procedure
  • Target Vessel Failure (TVF) rate at 6 and 12 months post-procedure
  • In-stent and in-segment minimum lumen diameter (MLD) at 6 months post-procedure
  • Failure of sustained patency at 6 months (≥70% stenosis with TIMI <3 flow at follow-up angiography)
  • Subacute thrombosis occurring within 30 days post-procedure


Information By: Duke University

Dates:
Date Received: September 19, 2006
Date Started: June 2005
Date Completion:
Last Updated: September 11, 2014
Last Verified: September 2014