Trial · NCT02389946
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
NCT02389946, Not applicable, Completed, Biotronik, Inc.; results first posted 2019-08-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions. Trials, record NCT02389946. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02389946
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
- NCT number
- NCT02389946
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,334 participants, actual
- Lead sponsor
- Biotronik, Inc.
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease, Acute Coronary Syndrome, Angina Pectoris
- Interventions
- Orsiro DES, Xience DES
- First posted
- 2015-03-17
- Last updated
- 2022-08-03
- Results first posted
- 2019-08-01
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure by Bayesian Estimation | 12-Months | TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR). |
| Secondary | Number of Lesions With Device Success | Hospital Discharge (6-24 hours post-index procedure) | Defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study stent only. |
| Secondary | Number of Lesions With Lesion Success | Hospital Discharge (6-24 hours post-index procedure) | Defined as attainment of \< 30% residual stenosis of the target lesion using any percutaneous method. |
| Secondary | Number of Participants With Procedure Success | Hospital Discharge (6-24 hours post-index procedure) | Defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study stent only without occurrence of in-hospital major adverse cardiac events (MACE; composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically-driven TLR). |
| Secondary | Number of Participants With Myocardial Infarction | Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years | |
| Secondary | Number of Participants With Myocardial Infarction or Cardiac Death | Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years | |
| Secondary | Number of Participants With MACE and Individual MACE Components | Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years | MACE events are defined as all-cause death, Q-wave or non-Q-wave MI, or any clinically-driven TLR. The number of participants with any MACE event is provided, as well as number of participants with each of the individual components. |
| Secondary | Number of Participants With TLF and Individual TLF Components | Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years | TLF events are defined as cardiac death, target vessel Q-wave or non-Q-wave MI, or any clinically-driven TLR. The number of participants with any TLF event is provided, as well as number of participants with each of the individual components. |
| Secondary | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years | TVF events are defined as cardiac death, target vessel Q-wave or non-Q-wave MI, or any clinically-driven TVR. The number of participants with any TVF event is provided, as well as number of participants with each of the individual components. |
| Secondary | Number of Participants With Stent Thrombosis | 24 hours, 30 days, 1 year, and 5 years post-index procedure | Stent thrombosis according to the Academic Research Consortium criteria. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure by Bayesian Estimation | 12-Months | Pre-specified Bayesian analysis: BIOFLOW-V intent-to-treat subjects who experienced the primary endpoint or had at least 330 days of follow-up and BIOFLOW-II (NCT01356888) and BIOFLOW-IV (NCT01939249) subjects who satisfied the BIOFLOW-V inclusion/exclusion criteria and experienced the primary endpoint or had at least 330 days of follow-up. | Percentage of participants | MEAN |
| SECONDARY | Number of Lesions With Device Success | Hospital Discharge (6-24 hours post-index procedure) | Device Success per lesion. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis. | Lesions | NUMBER |
| SECONDARY | Number of Lesions With Lesion Success | Hospital Discharge (6-24 hours post-index procedure) | Lesion Success per lesion. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis. | Lesions | COUNT_OF_UNITS |
| SECONDARY | Number of Participants With Procedure Success | Hospital Discharge (6-24 hours post-index procedure) | Procedure success was analyzed per subject: for a subject to be considered a procedure success, all of the subject's target lesions had to be considered device success. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Myocardial Infarction | Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years | Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Myocardial Infarction or Cardiac Death | Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years | Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With MACE and Individual MACE Components | Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years | Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TLF and Individual TLF Components | Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years | Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years | Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Stent Thrombosis | 24 hours, 30 days, 1 year, and 5 years post-index procedure | Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group252
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure by Bayesian Estimation | Orsiro Sirolimus Coronary Stent System | 6.32 | Standard Deviation 0.75 | Percentage of participants | |
| Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure by Bayesian Estimation | Xience Everolimus Coronary Stent System | 8.90 | Standard Deviation 1.22 | Percentage of participants | |
| Number of Lesions With Device Success | Orsiro Sirolimus Coronary Stent System | 1082 | Lesions | ||
| Number of Lesions With Device Success | Xience Everolimus Coronary Stent System | 566 | Lesions | ||
| Number of Lesions With Lesion Success | Orsiro Sirolimus Coronary Stent System | 1102 | Lesions | ||
| Number of Lesions With Lesion Success | Xience Everolimus Coronary Stent System | 579 | Lesions | ||
| Number of Participants With Procedure Success | Orsiro Sirolimus Coronary Stent System | 827 | Participants | ||
| Number of Participants With Procedure Success | Xience Everolimus Coronary Stent System | 401 | Participants | ||
| Number of Participants With Myocardial Infarction | Orsiro Sirolimus Coronary Stent System | 6-24 hours post-index procedure | 34 | Participants | |
| Number of Participants With Myocardial Infarction | Xience Everolimus Coronary Stent System | 6-24 hours post-index procedure | 30 | Participants |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Orsiro Sirolimus Coronary Stent System | 884 | |
| Overall Study | STARTED | Xience Everolimus Coronary Stent System | 450 | |
| Overall Study | COMPLETED | Orsiro Sirolimus Coronary Stent System | 860 | |
| Overall Study | COMPLETED | Xience Everolimus Coronary Stent System | 435 | |
| Overall Study | NOT COMPLETED | Orsiro Sirolimus Coronary Stent System | 24 | |
| Overall Study | NOT COMPLETED | Xience Everolimus Coronary Stent System | 15 |
Source ClinicalTrials.gov
Adverse events1,262
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Angina pectoris | Cardiac disorders | Orsiro Sirolimus Coronary Stent System | 159 | 884 | 215 |
| other | Angina pectoris | Cardiac disorders | Xience Everolimus Coronary Stent System | 94 | 450 | 125 |
| other | Non-cardiac chest pain | General disorders | Orsiro Sirolimus Coronary Stent System | 163 | 884 | 240 |
| other | Non-cardiac chest pain | General disorders | Xience Everolimus Coronary Stent System | 89 | 450 | 128 |
| other | Myocardial necrosis marker increased | Investigations | Orsiro Sirolimus Coronary Stent System | 174 | 884 | 176 |
| other | Myocardial necrosis marker increased | Investigations | Xience Everolimus Coronary Stent System | 90 | 450 | 91 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Orsiro Sirolimus Coronary Stent System | 100 | 884 | 112 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Xience Everolimus Coronary Stent System | 45 | 450 | 52 |
| other | Acute Myocardial Infarction | Cardiac disorders | Orsiro Sirolimus Coronary Stent System | 49 | 884 | 61 |
| other | Acute Myocardial Infarction | Cardiac disorders | Xience Everolimus Coronary Stent System | 26 | 450 | 35 |
1 to 10 of 1,262Source ClinicalTrials.gov
See all 1,262 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Orsiro Sirolimus Coronary Stent System | 56 | 884 |
| Total, all-cause mortality | Xience Everolimus Coronary Stent System | 27 | 450 |
| Total, other adverse events | Orsiro Sirolimus Coronary Stent System | 291 | 884 |
| Total, other adverse events | Xience Everolimus Coronary Stent System | 165 | 450 |
| Total, serious adverse events | Orsiro Sirolimus Coronary Stent System | 548 | 884 |
| Total, serious adverse events | Xience Everolimus Coronary Stent System | 293 | 450 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Orsiro Sirolimus Coronary Stent System vs Xience Everolimus Coronary Stent System: Number of Participants With Procedure Success | Trial comparisons |
| Orsiro Sirolimus Coronary Stent System vs Xience Everolimus Coronary Stent System: deaths from any cause | Trial comparisons |
| Orsiro Sirolimus Coronary Stent System vs Xience Everolimus Coronary Stent System: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02389946
GET https://conductscience.org/api/trials/v1/NCT02389946/results?page=2