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Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome
This study has been completed.
First Received: March 26, 2007   No Changes Posted
Sponsored by: University of Zagreb
Information provided by: University of Zagreb
ClinicalTrials.gov Identifier: NCT00452517
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Procedure: Percutaneous Coronary Intervention
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome: Clinical and Angiographic Follow-up

Resource links provided by NLM:


Further study details as provided by University of Zagreb:

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.

Estimated Enrollment: 100
Study Start Date: March 2004
Study Completion Date: November 2004
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452517

Locations
Croatia
University hospital Zagreb
Zagreb, Croatia, 10000
Sponsors and Collaborators
University of Zagreb
Investigators
Principal Investigator: Maja Strozzi, MD University hospital Zagreb
  More Information

Publications:
Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: SG-SIR-BM-07
Study First Received: March 26, 2007
Last Updated: March 26, 2007
ClinicalTrials.gov Identifier: NCT00452517     History of Changes
Health Authority: Croatia: University hospital Zagreb Ethical Committee

Keywords provided by University of Zagreb:
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

Study placed in the following topic categories:
Sirolimus
Anti-Infective Agents
Anti-Bacterial Agents
Heart Diseases
Immunologic Factors
Antifungal Agents
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases
Ischemia
Immunosuppressive Agents

Additional relevant MeSH terms:
Sirolimus
Anti-Infective Agents
Disease
Heart Diseases
Immunologic Factors
Antineoplastic Agents
Myocardial Ischemia
Physiological Effects of Drugs
Vascular Diseases
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Pathologic Processes
Antifungal Agents
Syndrome
Therapeutic Uses
Acute Coronary Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 10, 2009