This study is ongoing, but not recruiting participants.

Study NCT00180479 Information provided by Abbott Vascular

First Received: September 13, 2005 Last Updated: July 29, 2010 History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

July 29, 2010

Start Date ^ICMJE

June 2005

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE
(submitted: July 29, 2010)

Primary Endpoint: In-segment Late Loss (LL) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]

In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.

Original Primary Outcome Measures ^ICMJE
(submitted: September 13, 2005)

• Primary Endpoint: In-segment late loss (LL) at 240 days
• Major Secondary Endpoint: Ischemia driven target vessel failure (TVF) at 270 days

Change History

Complete list of historical versions of study NCT00180479 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE
(submitted: July 29, 2010)

• Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]

  The composite endpoint comprised of:

  • Cardiac death (death in which a cardiac cause cannot be excluded)
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
  • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
• Target Vessel Failure (TVF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

  The composite endpoint comprised of:

  • Cardiac death (death in which a cardiac cause cannot be excluded)
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
  • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
• Target Vessel Failure (TVF) [ Time Frame: 180 days ] [ Designated as safety issue: No ]

  The composite endpoint comprised of:

  • Cardiac death (death in which a cardiac cause cannot be excluded)
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
  • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
• Target Vessel Failure (TVF) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

  The composite endpoint comprised of:

  • Cardiac death (death in which a cardiac cause cannot be excluded)
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
  • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
• Target Vessel Failure (TVF) [ Time Frame: 2 year ] [ Designated as safety issue: No ]

  The composite endpoint comprised of:

  • Cardiac death (death in which a cardiac cause cannot be excluded)
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
  • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
• Target Vessel Failure (TVF) [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]

  The composite endpoint comprised of:

  • Cardiac death (death in which a cardiac cause cannot be excluded)
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
  • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
• Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

  Revascularization @ target lesion associated w/ any of following:

  (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study

• Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 180 days ] [ Designated as safety issue: No ]

  Revascularization @ target lesion associated w/ any of following:

  (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study

• Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 270 days ] [ Designated as safety issue: No ]

  Revascularization @ target lesion associated w/ any of following:

  (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study

• Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 1 years ] [ Designated as safety issue: No ]

  Revascularization @ target lesion associated w/ any of following:

  (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study

• Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

  Revascularization @ target lesion associated w/ any of following:

  (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study

• Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 3 year ] [ Designated as safety issue: No ]

  Revascularization @ target lesion associated w/ any of following:

  (+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study

• Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

  Revascularization at the target vessel associated with any of the following

  • Positive functional ischemia study
  • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
  • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
• Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 180 days ] [ Designated as safety issue: No ]

  Revascularization at the target vessel associated with any of the following

  • Positive functional ischemia study
  • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
  • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
• Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]

  Revascularization at the target vessel associated with any of the following

  • Positive functional ischemia study
  • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
  • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
• Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

  Revascularization at the target vessel associated with any of the following

  • Positive functional ischemia study
  • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
  • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
• Ischemia Drive Target Vessel Revascularization (ID-TVR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

  Revascularization at the target vessel associated with any of the following

  • Positive functional ischemia study
  • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
  • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
• Ischemia Drive Target Vessel Revascularization (ID-TVR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

  Revascularization at the target vessel associated with any of the following

  • Positive functional ischemia study
  • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
  • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
• Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

  The composite endpoint comprised of:

  • Cardiac death
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
• Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

  The composite endpoint comprised of:

  • Cardiac death
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
• Ischemia Driven Major Adverse Cardiac Event (MACE) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]