Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome

NCT00452517 | Completed Phase 4

• 1 other identifier: SG-SIR-BM-07
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Percutaneous Coronary Intervention PROCEDURE

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stent implantation in acute coronary syndrome

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

University hospital Zagreb

Zagreb, 10000, Croatia

Location

Related Publications (3)

• 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.

  PMID: 16488801 BACKGROUND

• 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.

  PMID: 14557354 BACKGROUND

• 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.

  PMID: 17589978 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Cardiovascular Diseases

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Maja Strozzi, MD

  University hospital Zagreb

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 26, 2007
• First Posted: March 27, 2007
• Study Start: March 1, 2004
• Study Completion: November 1, 2004
• Last Updated: March 27, 2007

Record last verified: 2007-03

Locations

CR (1)