Coronary Occlusions Clinical Trial
Official title:
Approaches to Chronic Occlusions With Sirolimus Stents-Cypher (ACROSS-Cypher) Total Occlusion Study of Coronary Arteries 4 Trial
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.
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 following successful crossing of native total occlusions with a
coronary guidewire. The study will be conducted at approximately 17 sites in North America.
Patients included in this trial will be scheduled for percutaneous revascularization of a
non-acute de novo TCO in a native vessel visually estimated to accommodate a ≥3.0 mm
diameter angioplasty balloon. Important exclusion criteria will include recent myocardial
infarction (<72 hours) and any general contraindication to the procedure or scheduled
clinical and angiographic follow-up. Patients may also undergo treatment of a non-target
vessel lesion simultaneous with the index procedure within certain protocol-specified
provisions. All patients will undergo planned angiographic follow-up 6 months following the
index procedure to evaluate the primary endpoint of restenosis (>50% diameter stenosis)
within the treated/working length segment compared with results obtained using the same
methodology among patients undergoing TCO revascularization with the heparin-coated
Palmaz-Schatz coronary stent (Cordis Corporation, Miami Lakes, FL) in the Total Occlusion
Study of Canada-1 (TOSCA) (1). Important secondary endpoints include the occurrence of major
adverse cardiac events (MACE) and target vessel failure (TVF) at 30 days, 6 months and 12
months post-procedure. In addition, angiographic outcomes of in-stent and segment restenosis
within the stent and segment will be examined. Further, patients enrolled in the trial will
have clinical follow-up annually to five years.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01012869 -
AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study
|
Phase 4 |