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Trial · NCT01665053

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPercentage of Participants With Target Lesion Failure (TLF) at 12 Months12 monthsTLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
SecondaryPercentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.12 monthsThe TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) \& TLR Coronary Artery Bypass Graft (CABG).
SecondaryPercentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.12 monthsTVR overall includes: TVR PCI \& TVR CABG.
SecondaryPercentage of Participants With Target Vessel Failure (TVF) at 12 Month.12 monthsTarget Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.
SecondaryPercentage of Participants With Myocardial Infarction at 12 Month.12 monthsThe MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel.
SecondaryPercentage of Participants With Cardiac Death at 12 Month.12 months
SecondaryPercentage of Participants With Non-Cardiac Death at 12 Month.12 months
SecondaryPercentage of Patients That Died at 12 Months.12 monthsThe Death rate includes Cardiac- \& Non-Cardiac Death.
SecondaryPercentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.12 months
SecondaryPercentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.12 months
SecondaryPercentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.12 months
SecondaryPercentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.12 months
SecondaryPercentage of Patients With a Stroke at 12 Month.12 monthsThe stroke rate includes: Ischemic- , Hemorraghic- \& Undetermined Stroke.
SecondaryPeriprocedural Technical Success Rate.Day 1 (periprocedure)
Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based.
SecondaryPeriprocedural Clinical Procedural Success RateDay 1 (periprocedure)
Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based.
SecondaryPercentage of Participants With a Target Lesion Failure (TLF) at 12 Month.12 month
SecondaryPercentage of Patients With Revascularization (=All Revascularizations) at 12 Month.12 MonthAll CEC adjudicated revascularization at 12 month (Intent to treat population).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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