Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452517
Status:
COMPLETED
Last Update Posted:
2007-03-27
First Post:
2007-03-26
Brief Title:
Comparison of Stent Graft Sirolimus Stent and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome
Sponsor:
University of Zagreb
Organization:
University of Zagreb
Study Overview
Official Title:
Comparison of Stent Graft Sirolimus Stent and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome Clinical and Angiographic Follow-up
Status:
COMPLETED
Status Verified Date:
2007-03
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:
During the 6-month period 119 patients with acute coronary syndrome were randomized to either stent graft group n40 sirolimus eluting stent group n39 or bare metal stent group n40 Demographic angiographic and procedural characteristics were similar for all three groups The incidence of 6-month major adverse coronary events were analysed
Detailed Description:
Background Percutaneous coronary intervention with stent implantation is a standard therapy for patients with acute coronary syndrome The in-stent restenosis is still a problem Recently drug eluting stents reduce the incidence of this unfavorable event The primary role of the polytetrafluoroethylene stent graft PTFE is management of coronary perforations closure of coronary aneurysms and in degenerated saphenous vein grafts We compared these stents in native coronary vessels in patients with acute coronary syndrome with sirolimus and bare metal stents for possible reduction of in-stent restenosis
Methods and results During the 6-month period 119 patients with acute coronary syndrome were randomized to either stent graft group n40 sirolimus eluting stent group n39 or bare metal stent group n40 Demographic angiographic and procedural characteristics were similar for all three groups The incidence of 6-month major adverse coronary events was similar in all three groups The target lesion revascularisation was higher in the bare metal stent group P0044 The primary end-point restenosis rate at six-month follow-up was higher in the bare metal stent group compared with the stent graft and sirolimus eluting stent groups The percent diameter stenosis in follow-up was significantly higher in bare metal stent group P0005 The late loss was significantly lower in the sirolimus eluting stent group 023 mm compared with the bare metal stent group P 0034 There was a trend of lower late loss in the stent graft group compared with bare metal stent group
Conclusion Three groups of stents implanted in patients with acute coronary syndrome stent-graft sirolimus and bare metal did not differ regarding the incidence of major adverse cardiac events Sirolimus-eluting stents had a lower incidence of in-stent restenosis in comparison with bare metal stent group Stent graft implanted in native coronary arteries appears to be safe and efficient in patients with acute coronary syndrome but a significant reduction of in-stent restenosis was not achieved
Methods and results During the 6-month period 119 patients with acute coronary syndrome were randomized to either stent graft group n40 sirolimus eluting stent group n39 or bare metal stent group n40 Demographic angiographic and procedural characteristics were similar for all three groups The incidence of 6-month major adverse coronary events was similar in all three groups The target lesion revascularisation was higher in the bare metal stent group P0044 The primary end-point restenosis rate at six-month follow-up was higher in the bare metal stent group compared with the stent graft and sirolimus eluting stent groups The percent diameter stenosis in follow-up was significantly higher in bare metal stent group P0005 The late loss was significantly lower in the sirolimus eluting stent group 023 mm compared with the bare metal stent group P 0034 There was a trend of lower late loss in the stent graft group compared with bare metal stent group
Conclusion Three groups of stents implanted in patients with acute coronary syndrome stent-graft sirolimus and bare metal did not differ regarding the incidence of major adverse cardiac events Sirolimus-eluting stents had a lower incidence of in-stent restenosis in comparison with bare metal stent group Stent graft implanted in native coronary arteries appears to be safe and efficient in patients with acute coronary syndrome but a significant reduction of in-stent restenosis was not achieved
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