Trial · NCT03168776
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements | 12 months | TLF is defined as the composite of cardiac death, target vessel related myocardial infarction (TV-MI), and clinically-driven target lesion revascularization (TLR) |
| Secondary | Number of Participants With Cardiac Death | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Any death due to proximate cardiac cause (e.g., MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. |
| Secondary | Number of Participants With Major Adverse Cardiac Events (MACE) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | All-cause death, myocardial infarction, or target vessel revascularization (reported as a composite) |
| Secondary | Number of Participants With Myocardial Infarction (MI) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Defined according to the modified Third Universal Definition as evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. |
| Secondary | Number of Participants With Stent Thrombosis | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Definite or probable (ARC-defined), classified as early, late, or very late |
| Secondary | Number of Participants With Bleeding Complications (BARC Definitions) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Evaluated as components and as a composite of BARC Type 3 or 5 bleeding, including: Type 3a: Over bleeding plus hemoglobin drop of 3 to \<5 g/dL\* (provided hemoglobin drop is related to bleed); Any transfusion with over bleeding Type 3b: Overt bleeding plus hemoglobin drop ≥5 g/dL\* (provided hemoglobin drop is related to bleed); Cardiac tamponade; Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid); Bleeding requiring intravenous vasoactive agents Type 3c: Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal); Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed comprising vision Type 5: Fatal bleeding |
| Secondary | Lesion Success | Post-Procedure | Defined as attainment of \<30% residual stenosis, as measured by quantitative coronary angiography (QCA) using any percutaneous method \[evaluated post-procedure\] |
| Secondary | Device Success | Post-Procedure | Defined as attainment of \<30% residual stenosis of the target lesion measured by QCA using the assigned device \[evaluated post-procedure\] |
| Secondary | Procedure Success | Post procedure/Prior to Discharge, an average of 3 days | Defined as lesion success without the occurrence of in-hospital MACE \[evaluated in-hospital\] |
| Secondary | Clinically-driven Target Vessel Revascularization (TVR) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 70% (by core lab quantitative coronary angiography assessment) OR percent diameter stenosis ≥ 50% (by core lab quantitative coronary angiography assessment) accompanied by one of the following:103 1. a positive history of recurrent angina pectoris, presumably related to the target vessel; 2. objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent) presumably related to the target vessel; 3. abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve). |
| Secondary | Target Vessel Failure (TVF) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | The composite of cardiac death, target vessel-related myocardial infarction, and clinically-driven target vessel revascularization. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03168776/registered