Trial · NCT01665053
The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)
NCT01665053, Phase 3, Completed, Boston Scientific Corporation; results first posted 2016-01-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s). Trials, record NCT01665053. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01665053
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)
- NCT number
- NCT01665053
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,684 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Coronary Artery Disease
- Interventions
- PROMUS Element Plus, SYNERGY
- First posted
- 2012-08-15
- Last updated
- 2019-01-30
- Results first posted
- 2016-01-07
Source ClinicalTrials.gov
Registered outcomes17
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 | 12 months | TLF 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. |
| Secondary | Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months. | 12 months | The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) \& TLR Coronary Artery Bypass Graft (CABG). |
| Secondary | Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months. | 12 months | TVR overall includes: TVR PCI \& TVR CABG. |
| Secondary | Percentage of Participants With Target Vessel Failure (TVF) at 12 Month. | 12 months | Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death. |
| Secondary | Percentage of Participants With Myocardial Infarction at 12 Month. | 12 months | The 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. |
| Secondary | Percentage of Participants With Cardiac Death at 12 Month. | 12 months | |
| Secondary | Percentage of Participants With Non-Cardiac Death at 12 Month. | 12 months | |
| Secondary | Percentage of Patients That Died at 12 Months. | 12 months | The Death rate includes Cardiac- \& Non-Cardiac Death. |
| Secondary | Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month. | 12 months | |
| Secondary | Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month. | 12 months |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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 | 12 months | The per protocol population was used for this analysis. Therefore the number of participants analyzed is not consistent with the numbers provided in participant flow module. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months. | 12 months | Intent-to-Treat population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months. | 12 months | Intent-to- Treat | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Target Vessel Failure (TVF) at 12 Month. | 12 months | Intent-to-treat analysis | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Myocardial Infarction at 12 Month. | 12 months | Intent-to-treat | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Cardiac Death at 12 Month. | 12 months | Intent-to-treat population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Non-Cardiac Death at 12 Month. | 12 months | Intent-to-treat population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients That Died at 12 Months. | 12 months | Intent-to-treat population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month. | 12 months | Intent-to-treat population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month. | 12 months | Intent-to-treat population | percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group34
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 | Promus Element Plus | 6.4 | percentage of participants | ||
| Percentage of Participants With Target Lesion Failure (TLF) at 12 Months | SYNERGY | 6.4 | percentage of participants | ||
| Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months. | Promus Element Plus | 1.7 | percentage of participants | ||
| Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months. | SYNERGY | 2.6 | percentage of participants | ||
| Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months. | Promus Element Plus | 3.6 | percentage of participants | ||
| Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months. | SYNERGY | 3.8 | percentage of participants | ||
| Percentage of Participants With Target Vessel Failure (TVF) at 12 Month. | Promus Element Plus | 8.2 | percentage of participants | ||
| Percentage of Participants With Target Vessel Failure (TVF) at 12 Month. | SYNERGY | 8.2 | percentage of participants | ||
| Percentage of Participants With Myocardial Infarction at 12 Month. | Promus Element Plus | 5.0 | percentage of participants | ||
| Percentage of Participants With Myocardial Infarction at 12 Month. | SYNERGY | 5.4 | percentage of participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Promus Element Plus | 838 | |
| Overall Study | STARTED | SYNERGY | 846 | |
| Overall Study | Completed 12-Month Clinical F/U | Promus Element Plus | 797 | |
| Overall Study | Completed 12-Month Clinical F/U | SYNERGY | 822 | |
| Overall Study | No 12-Month F/U | Promus Element Plus | 32 | |
| Overall Study | No 12-Month F/U | SYNERGY | 15 | |
| Overall Study | Death With No 12-month Clinical FU | Promus Element Plus | 9 | |
| Overall Study | Death With No 12-month Clinical FU | SYNERGY | 9 | |
| Overall Study | COMPLETED | Promus Element Plus | 806 | |
| Overall Study | COMPLETED | SYNERGY | 831 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events120
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 | Promus Element Plus | 104 | 838 | 125 |
| other | Angina Pectoris | Cardiac disorders | SYNERGY | 100 | 846 | 116 |
| other | Myocardial infarction | Cardiac disorders | Promus Element Plus | 70 | 838 | 70 |
| other | Myocardial infarction | Cardiac disorders | SYNERGY | 74 | 846 | 74 |
| other | Coronary artery dissection | Cardiac disorders | Promus Element Plus | 27 | 838 | 28 |
| other | Coronary artery dissection | Cardiac disorders | SYNERGY | 32 | 846 | 33 |
| other | Angina unstable | Cardiac disorders | Promus Element Plus | 18 | 838 | 19 |
| other | Angina unstable | Cardiac disorders | SYNERGY | 20 | 846 | 24 |
| other | Acute myocardial infarction | Cardiac disorders | Promus Element Plus | 11 | 838 | 12 |
| other | Acute myocardial infarction | Cardiac disorders | SYNERGY | 17 | 846 | 17 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Promus Element Plus | ||
| Total, all-cause mortality | SYNERGY | ||
| Total, other adverse events | Promus Element Plus | 576 | 838 |
| Total, other adverse events | SYNERGY | 567 | 846 |
| Total, serious adverse events | Promus Element Plus | 262 | 838 |
| Total, serious adverse events | SYNERGY | 265 | 846 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Promus Element Plus vs SYNERGY: serious adverse events |
Source 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/NCT01665053
GET https://conductscience.org/api/trials/v1/NCT01665053/results?page=2