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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
University of Zagreb
About
Eligibility
Locations
Outcomes
Full info

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

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 26, 2007
Last Updated
March 26, 2007
Sponsor
University of Zagreb
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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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