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Drug Eluting Stent (DES) in Primary Angioplasty (PASEO)
This study has been completed.
Study NCT00759850   Information provided by San Giuseppe Moscati Hospital
First Received: September 24, 2008   No Changes Posted

September 24, 2008
September 24, 2008
October 2003
October 2005   (final data collection date for primary outcome measure)
The primary end point was target lesion revascularization (TLR) at 1-year follow-up [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Cumulative combined incidence of death and/or reinfarction at 2 year; Cumulative incidence of in-stent thrombosis at 2 year; 3) Major Adverse Cardiac Events (MACE) (combined death and/or reinfarction and/or TLR) at 2 years [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
Same as current
 
Drug Eluting Stent (DES) in Primary Angioplasty
PaclitAxel or Sirolimus-Eluting Stent vs Bare Metal Stent in Primary Angioplasty (PASEO) Randomized Trial

Stent implantation is the best treatment in patients with acute myocardial infarction (STEMI) referred for primary angioplasty (pPCI). However the occurrence of in stent restenosis is responsible for the need of repeat intervention. Both Sirolimus-eluting stents (SES) and Paclitaxel-eluting stents (PES) have been proven to virtually abolish in-stent restenosis in elective patients in simple e more complex lesions. Both SES and PES have raised concerns regarding occurrence of late stent thrombosis, especially in complex lesion subsets or in high risk patients. The PaclitAxel or Sirolimus-Eluting Stent vs Bare Metal Stent in primary angioplasty (PASEO) trial was a prospective, single-center, randomized trial evaluating the benefits of SES or PES as compared to BMS implantation in patients undergoing primary angioplasty for acute STEMI. From 1 October 2003 we randomized with 1:1:1 ratio, 270 patients with STEMI and treated with pPCI, to implantation of a bare metal stent (BMS n=90), PES (n=90) or SES (n=90).

 
Phase II, Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Acute Myocardial Infarction
Device: Drug Eluting Stent (DES)
  • Active Comparator: Patient with ST elevation myocardial infarction randomly assigned to receive a Bare Metal Stent n=90)
  • Experimental: Patient with ST elevation myocardial infarction randomly assigned to receive a Paclitaxel Eluting Stent (n=90)
  • Experimental: Patient with ST elevation myocardial infarction randomly assigned to receive a Sirolimus Eluting Stent (n=90)

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
270
December 2007
October 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical symptoms of STEMI, with initial onset of chest pain within the past 12 hours, an ECG demonstrating > 0.1 mV ST-segment elevation in 2 or more contiguous leads or documented new left bundle-branch block and were suitable candidates for percutaneous revascularization.

Exclusion Criteria:

  • Active internal bleeding or a history of bleeding diathesis within the previous 30 days
  • An history of intracranial hemorrhage
  • Intracranial neoplasm
  • Arteriovenous malformation or aneurysm
  • Known allergy to sirolimus
  • Paclitaxel
  • Heparin, aspirin, or clopidogrel
  • An history of stroke within 30 days or any history of hemorrhagic stroke
  • History, symptoms, or findings suggestive of aortic dissection, fibrinolytic therapy within 24 hours
  • History of thrombocytopenia, pregnancy, patients on warfarin or acenocoumarol within the last seven days
  • Inability to obtain the informed consent
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00759850
Emilio Di Lorenzo MD PhD, Division Of Cardiology
AOM_DES01
San Giuseppe Moscati Hospital
 
Principal Investigator: Emilio Di Lorenzo, MD PhD Division of Cardiology A.O. Moscati Avellino Italy
San Giuseppe Moscati Hospital
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP