Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Phase 4
Locations
Croatia
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention
Sponsored by

About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring bare metal stents, sirolimus-eluting stents, coronary polytetrafluoroethylene stent graft, acute coronary syndrome, quantitative coronary angiography analysis, major adverse cardiac events, in-stent restenosis, target lesion revascularisation
Eligibility Criteria
Inclusion Criteria:
- stent implantation in acute coronary syndrome
Exclusion Criteria:
- previous percutaneous coronary intervention or coronary artery bypass graft surgery
- multivessel, diffuse disease, tortuous vessel
- arteries less than 3 mm in diameter
- distal stenosis location
- left main and bifurcation lesions
Sites / Locations
- University hospital Zagreb
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00452517
Brief Title
Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome
Official Title
Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome: Clinical and Angiographic Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zagreb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
During the 6-month period 119 patients with acute coronary syndrome, were randomized to either stent graft group (n=40), sirolimus eluting stent group (n=39), or bare metal stent group (n=40). 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 (n=40), sirolimus eluting stent group (n=39), or bare metal stent group (n=40). 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 (P=0.044). 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 (P=0.005). The late loss was significantly lower in the sirolimus eluting stent group (0.23 mm), compared with the bare metal stent group (P= 0.034). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
bare metal stents, sirolimus-eluting stents, coronary polytetrafluoroethylene stent graft, acute coronary syndrome, quantitative coronary angiography analysis, major adverse cardiac events, in-stent restenosis, target lesion revascularisation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stent implantation in acute coronary syndrome
Exclusion Criteria:
previous percutaneous coronary intervention or coronary artery bypass graft surgery
multivessel, diffuse disease, tortuous vessel
arteries less than 3 mm in diameter
distal stenosis location
left main and bifurcation lesions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maja Strozzi, MD
Organizational Affiliation
University hospital Zagreb
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
12. IPD Sharing Statement
Citations:
PubMed Identifier
16488801
Citation
Keeley EC, Boura JA, Grines CL. Comparison of primary and facilitated percutaneous coronary interventions for ST-elevation myocardial infarction: quantitative review of randomised trials. Lancet. 2006 Feb 18;367(9510):579-88. doi: 10.1016/S0140-6736(06)68148-8. Erratum In: Lancet. 2006 May 20;367(9523):1656.
Results Reference
background
PubMed Identifier
14557354
Citation
Saia F, Lemos PA, Lee CH, Arampatzis CA, Hoye A, Degertekin M, Tanabe K, Sianos G, Smits PC, McFadden E, Hofma SH, van der Giessen WJ, de Feyter PJ, van Domburg RT, Serruys PW. Sirolimus-eluting stent implantation in ST-elevation acute myocardial infarction: a clinical and angiographic study. Circulation. 2003 Oct 21;108(16):1927-9. doi: 10.1161/01.CIR.0000096053.87580.CD. Epub 2003 Oct 13.
Results Reference
background
PubMed Identifier
17589978
Citation
Strozzi M, Anic D. Comparison of stent graft, sirolimus stent, and bare metal stent implanted in patients with acute coronary syndrome: clinical and angiographic follow-up. Croat Med J. 2007 Jun;48(3):348-52.
Results Reference
derived
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Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome
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