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Trial · NCT01995487

Registered outcomes17

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

ListOutcomeTime frameDescription
PrimaryTarget Lesion Failure (TLF)12 monthsThe primary endpoint of TLF at 12 months was defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR.
SecondaryDevice SuccessDetermined at time of baseline procedureClinical: Acute secondary endpoint determined at time of baseline procedure
SecondaryTLF30 days, 6 months, and 1, 2, 3, 4 and 5 yearsClinical secondary endpoint to be evaluated at 30 days, 6 months, and 2, 3, 4 and 5 years, defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR
SecondaryMajor Adverse Cardiac Events30 days, 6 months, and 1, 2, 3, 4 and 5 yearsClinical: MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR
SecondaryTarget Vessel Failure30 days, 6 months, and 1, 2, 3, 4 and 5 yearsClinical: TVF; the composite rate of death, target vessel related MI or ischemia-driven TVR
SecondaryAll Cause Mortality30 days, 6 months, and 1, 2, 3, 4 and 5 yearsClinical: The number of patients who die from all causes
SecondaryCardiac Death30 days, 6 months, and 1, 2, 3, 4 and 5 yearsClinical: The number of patients who die of cardiac-related causes
SecondaryMyocardial Infarction30 days, 6 months, and 1, 2, 3, 4 and 5 yearsClinical: The number of patients who suffer a myocardial infarction.
SecondaryTarget Vessel Related MI30 days, 6 months, and 1, 2, 3, 4 and 5 yearsClinical: The number of patients who suffer a MI that is related to the target vessel of the procedure.
SecondaryIschemia Driven TLR30 days, 6 months, and 1, 2, 3, 4 and 5 yearsClinical:
SecondaryIschemia Driven TVR30 days, 6 months, and 1, 2, 3, 4 and 5 yearsClinical:
SecondaryStent Thrombosis30 days, 6 months, and 1, 2, 3, 4 and 5 yearsClinical: ARC definite and probable
SecondaryAngiographic Sub-Study: In-stent and In-segment Late Loss13 monthsSecondary Endpoint for angiographic in-stent and in-segment late loss
SecondaryIVUS Sub-Study: In-stent Percent Neointimal Hyperplasia13 monthsIVUS: In-stent percent neointimal hyperplasia
SecondaryIVUS Sub-Study: Stent Mal-apposition13 monthsIVUS Sub-Study: Stent mal-apposition
SecondaryLesion SuccessDetermined at time of baseline procedureMeasures whether the lesion was successfully treated.
SecondaryProcedure SuccessDetermined at time of baseline procedureAcute clinical endpoint: The success of the procedure as determined at time of baseline procedure

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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