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Trial · NCT01751906

Outcomes52

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Cardiac Death/TV-MI/ID-TLR (TLF)1 yearIntent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Powered Secondary Endpoint: Angina1 year
The analysis will exclude angina following the index procedure through discharge, not to exceed a period of 7 days. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Powered Secondary Endpoint: All Revascularization1 year
ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through 1 year without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)1 year
For ID-TVR, Fisher's exact test is used for superiority testing based on the ITT population. This analysis will include \~2000 subjects. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYAcute Success- Device Success (Lesion Level Analysis)On day 0 (the day of procedure)Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.Percentage of lesionsNUMBER
SECONDARYAcute Success: Procedural Success (Subject Level Analysis)On day 0 (the day of procedure)Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Death (Cardiac, Vascular, Non-cardiovascular)0 to 5 yearsITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With All Myocardial Infarction (MI)0 to 5 yearsITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With All Target Lesion Revascularization (TLR)0 to 5 yearsITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)0 to 5 yearsITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With All Revascularization0 to 5 yearsITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Death/All MI0 to 5 yearsITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Cardiac Death/All MI0 to 5 yearsITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Cardiac Death/TV-MI/ID-TLR (TLF)0 to 5 yearsITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)0 to 5 yearsITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Target Vessel Failure (TVF)0 to 5 yearsITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Death/All MI/All Revascularization (DMR)0 to 5 yearsITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition)≤ 1 Day
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition)0 to 30 Days
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Subacute Stent/Scaffold Thrombosis>1 to 30 Days
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
ParticipantsCOUNT_OF_PARTICIPANTS

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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