Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00378612
Status:
COMPLETED
Last Update Posted:
2014-09-12
First Post:
2006-09-19
Brief Title:
ACROSS-Cypher Total Occlusion Study of Coronary Arteries 4 Trial
Sponsor:
Sunil Rao
Organization:
Duke University
Study Overview
Official Title:
Approaches to Chronic Occlusions With Sirolimus Stents-Cypher ACROSS-Cypher Total Occlusion Study of Coronary Arteries 4 Trial
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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 147 in adjusted 4-year mortality P004 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 stents 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 30 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 treatedworking 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
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 147 in adjusted 4-year mortality P004 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 stents 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 30 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 treatedworking 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1525004 | OTHER | Legacy ID | None |