Coronary Artery Disease
Conditions
Keywords
Drug-Eluting Stents
Brief summary
The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).
Detailed description
A concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy and a consecutive, non-randomized, single-arm, Diabetes substudy will also enroll under the EVOLVE II protocol.
Interventions
DEVICEPROMUS Element Plus
A drug eluting coronary stent system
DEVICESYNERGY
A drug eluting coronary stent system
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must be at least 18 years of age * Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed * For subjects less than 20 years of age enrolled at a Japanese site, the subject and the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed * Subject is eligible for percutaneous coronary intervention (PCI) * Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia * Subject is an acceptable candidate for coronary artery bypass grafting (CABG) * Subject is willing to comply with all protocol-required follow-up evaluation Angiographic Inclusion Criteria (visual estimate): * Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm * Target lesion(s) length must be ≤34 mm (by visual estimate) * Target lesion(s) must have visually estimated stenosis ≥50% and \<100% with thrombolysis in Myocardial Infarction (TIMI) flow \>1 and one of the following: stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure * Coronary anatomy is likely to allow delivery of a study device to the target lesions(s) * The first lesion treated must be successfully predilated/pretreated
Exclusion criteria
* Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI) * Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina * Subject has received an organ transplant or is on a waiting list for an organ transplant * Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure * Planned PCI (including staged procedures) or CABG after the index procedure * Subject previously treated at any time with intravascular brachytherapy \_ Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin) * Subject has one of the following (as assessed prior to the index procedure): * Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months * Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.) * Planned procedure that may cause non-compliance with the protocol or confound data interpretation * Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome * Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 * Subject has a white blood cell (WBC) count \< 3,000 cells/mm3 * Subject has documented or suspected liver disease, including laboratory evidence of hepatitis * Subject is on dialysis or has baseline serum creatinine level \>2.0 mg/dL (177µmol/L) * Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions * Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months * Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding * Subject has severe symptomatic heart failure (i.e., NYHA class IV) * Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint * Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure * Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure) * Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential) Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| Percentage of Participants With Cardiac Death at 12 Month. | 12 months | — |
| Percentage of Participants With Non-Cardiac Death at 12 Month. | 12 months | — |
| Percentage of Patients That Died at 12 Months. | 12 months | The Death rate includes Cardiac- & Non-Cardiac Death. |
| Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month. | 12 months | — |
| Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months. | 12 months | TVR overall includes: TVR PCI & TVR CABG. |
| Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month. | 12 months | — |
| Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month. | 12 months | — |
| Percentage of Patients With a Stroke at 12 Month. | 12 months | The stroke rate includes: Ischemic- , Hemorraghic- & Undetermined Stroke. |
| Periprocedural Technical Success Rate. | Day 1 (periprocedure) | Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based. |
| Periprocedural Clinical Procedural Success Rate | Day 1 (periprocedure) | Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based. |
| Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month. | 12 month | — |
| Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month. | 12 Month | All CEC adjudicated revascularization at 12 month (Intent to treat population). |
| Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month. | 12 months | — |
Countries
Australia, Austria, Belgium, Canada, Denmark, Finland, France, Italy, Japan, Latvia, Netherlands, New Zealand, Poland, Singapore, Spain, United States
Participant flow
Recruitment details
A total of 1684 patients have been enrolled in the study Evolve II Randomizes Clinical trial (RCT) from 26 November 2012 until 29 Aug 2013. The Evolve II RCT study is anticipated to be completed (final 5-year follow-up) in 2018.
Participants by arm
| Arm | Count |
|---|---|
| Promus Element Plus PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system | 838 |
| SYNERGY SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system | 846 |
| Total | 1,684 |
Baseline characteristics
| Characteristic | Total | SYNERGY | Promus Element Plus |
|---|---|---|---|
| Age, Continuous | 63.70 yr STANDARD_DEVIATION 10.47 | 63.48 yr STANDARD_DEVIATION 10.44 | 63.92 yr STANDARD_DEVIATION 10.5 |
| Baseline Lesion Characteristics as determined by the Angiographic Core Laboratory, ITT Analysis Set Left Anterior Descending (LAD) | 870 Number of lesions | 437 Number of lesions | 433 Number of lesions |
| Baseline Lesion Characteristics as determined by the Angiographic Core Laboratory, ITT Analysis Set Left Circumflex Artery (LCx) | 540 Number of lesions | 265 Number of lesions | 275 Number of lesions |
| Baseline Lesion Characteristics as determined by the Angiographic Core Laboratory, ITT Analysis Set Left Main Coronary Artery (LMCA) | 1 Number of lesions | 0 Number of lesions | 1 Number of lesions |
| Baseline Lesion Characteristics as determined by the Angiographic Core Laboratory, ITT Analysis Set Right Coronary Artery (RCA) | 691 Number of lesions | 357 Number of lesions | 334 Number of lesions |
| Current Diabetes Mellitus Current Diabetes Mellitus | 551 participants | 275 participants | 276 participants |
| Current Diabetes Mellitus No Current Diabetes Mellitus | 1133 participants | 571 participants | 562 participants |
| Height | 67.33 inches STANDARD_DEVIATION 4.04 | 67.23 inches STANDARD_DEVIATION 4 | 67.44 inches STANDARD_DEVIATION 4.07 |
| History of bleeding disorder Hystory of bleeding disorder | 3 participants | 2 participants | 1 participants |
| History of bleeding disorder No history of bleeding disorder | 1681 participants | 844 participants | 837 participants |
| History of cerebrovascular accident History of Cerebrovascular Accident | 62 participants | 30 participants | 32 participants |
| History of cerebrovascular accident No History of Cerebrovascular Accident | 1622 participants | 816 participants | 806 participants |
| History of GI bleeding History of GI Bleeding | 2 participants | 2 participants | 0 participants |
| History of GI bleeding No History of GI Bleeding | 1682 participants | 844 participants | 838 participants |
| History of peripheral vascular disease (PVD) History of PVD | 127 participants | 68 participants | 59 participants |
| History of peripheral vascular disease (PVD) No History of PVD | 1557 participants | 778 participants | 779 participants |
| History of renal disease History of renal disease | 108 participants | 56 participants | 52 participants |
| History of renal disease No History of renal disease | 1576 participants | 790 participants | 786 participants |
| History of Transient Ischemic Attack History of Transient Ischemic Attack | 47 participants | 24 participants | 23 participants |
| History of Transient Ischemic Attack No History of Transient Ischemic Attack | 1637 participants | 822 participants | 815 participants |
| History of Transient Ischemic Attack (TIA) or Cerebrovasular Accident (CVA) History of TIA or CVA | 97 participants | 48 participants | 49 participants |
| History of Transient Ischemic Attack (TIA) or Cerebrovasular Accident (CVA) No history of TIA or CVA | 1587 participants | 798 participants | 789 participants |
| Hyperlipidemia Requiring Medication Hyperlipidemia Requiring Medication | 1246 participants | 625 participants | 621 participants |
| Hyperlipidemia Requiring Medication No Hyperlipidemia requiring Medication | 438 participants | 221 participants | 217 participants |
| Hypertension Requiring Medication Hypertension requiring medication | 1281 participants | 652 participants | 629 participants |
| Hypertension Requiring Medication No Hypertension requiring medication | 403 participants | 194 participants | 209 participants |
| Race/Ethnicity, Customized American Indian or Alaska native | 3 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 200 participants | 100 participants | 100 participants |
| Race/Ethnicity, Customized Black,of African heritage | 89 participants | 52 participants | 37 participants |
| Race/Ethnicity, Customized Caucasian | 1319 participants | 655 participants | 664 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 31 participants | 15 participants | 16 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 5 participants | 3 participants | 2 participants |
| Race/Ethnicity, Customized Not Disclosed | 33 participants | 20 participants | 13 participants |
| Race/Ethnicity, Customized Other | 9 participants | 4 participants | 5 participants |
| Region of Enrollment Australia | 33 participants | 17 participants | 16 participants |
| Region of Enrollment Austria | 3 participants | 1 participants | 2 participants |
| Region of Enrollment Belgium | 100 participants | 50 participants | 50 participants |
| Region of Enrollment Canada | 114 participants | 58 participants | 56 participants |
| Region of Enrollment Denmark | 19 participants | 10 participants | 9 participants |
| Region of Enrollment Finland | 30 participants | 16 participants | 14 participants |
| Region of Enrollment France | 43 participants | 23 participants | 20 participants |
| Region of Enrollment Italy | 21 participants | 11 participants | 10 participants |
| Region of Enrollment Japan | 155 participants | 74 participants | 81 participants |
| Region of Enrollment Latvia | 23 participants | 11 participants | 12 participants |
| Region of Enrollment Netherlands | 25 participants | 12 participants | 13 participants |
| Region of Enrollment New Zealand | 24 participants | 11 participants | 13 participants |
| Region of Enrollment Poland | 9 participants | 5 participants | 4 participants |
| Region of Enrollment Singapore | 27 participants | 15 participants | 12 participants |
| Region of Enrollment Spain | 38 participants | 18 participants | 20 participants |
| Region of Enrollment United States | 1020 participants | 514 participants | 506 participants |
| Sex: Female, Male Female | 478 Participants | 249 Participants | 229 Participants |
| Sex: Female, Male Male | 1206 Participants | 597 Participants | 609 Participants |
| Smoking Smoking, Ever | 1029 participants | 510 participants | 519 participants |
| Smoking Smoking, Never | 624 participants | 317 participants | 307 participants |
| Smoking Smoking,Unknown | 31 participants | 19 participants | 12 participants |
| Weight | 190.69 lbs STANDARD_DEVIATION 44.18 | 190.92 lbs STANDARD_DEVIATION 44.09 | 190.45 lbs STANDARD_DEVIATION 44.29 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 576 / 838 | 567 / 846 |
| serious Total, serious adverse events | 262 / 838 | 265 / 846 |
Outcome results
Primary
Percentage of Participants With Target Lesion Failure (TLF) at 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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Percentage of Participants With Target Lesion Failure (TLF) at 12 Months | 6.4 percentage of participants |
| SYNERGY | Percentage of Participants With Target Lesion Failure (TLF) at 12 Months | 6.4 percentage of participants |
Secondary
Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.
Time frame: 12 months
Population: Intent-to-treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month. | 8.4 percentage of participants |
| SYNERGY | Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month. | 9.3 percentage of participants |
Secondary
Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.
Time frame: 12 months
Population: Intent-to-treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month. | 5.8 percentage of participants |
| SYNERGY | Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month. | 6.3 percentage of participants |
Secondary
Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.
Time frame: 12 months
Population: Intent-to-treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month. | 0.7 percentage of participants |
| SYNERGY | Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month. | 0.6 percentage of participants |
Secondary
Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.
Time frame: 12 month
Population: Intent-to-Treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month. | 6.4 percentage of participants |
| SYNERGY | Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month. | 6.6 percentage of participants |
Secondary
Percentage of Participants With Cardiac Death at 12 Month.
Time frame: 12 months
Population: Intent-to-treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Percentage of Participants With Cardiac Death at 12 Month. | 0.9 percentage of participants |
| SYNERGY | Percentage of Participants With Cardiac Death at 12 Month. | 0.5 percentage of participants |
Secondary
Percentage of Participants With Myocardial Infarction at 12 Month.
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.
Time frame: 12 months
Population: Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Percentage of Participants With Myocardial Infarction at 12 Month. | 5.0 percentage of participants |
| SYNERGY | Percentage of Participants With Myocardial Infarction at 12 Month. | 5.4 percentage of participants |
Secondary
Percentage of Participants With Non-Cardiac Death at 12 Month.
Time frame: 12 months
Population: Intent-to-treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Percentage of Participants With Non-Cardiac Death at 12 Month. | 0.2 percentage of participants |
| SYNERGY | Percentage of Participants With Non-Cardiac Death at 12 Month. | 0.6 percentage of participants |
Secondary
Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.
The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) & TLR Coronary Artery Bypass Graft (CABG).
Time frame: 12 months
Population: Intent-to-Treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months. | 1.7 percentage of participants |
| SYNERGY | Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months. | 2.6 percentage of participants |
Secondary
Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.
Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.
Time frame: 12 months
Population: Intent-to-treat analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Percentage of Participants With Target Vessel Failure (TVF) at 12 Month. | 8.2 percentage of participants |
| SYNERGY | Percentage of Participants With Target Vessel Failure (TVF) at 12 Month. | 8.2 percentage of participants |
Secondary
Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.
TVR overall includes: TVR PCI & TVR CABG.
Time frame: 12 months
Population: Intent-to- Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months. | 3.6 percentage of participants |
| SYNERGY | Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months. | 3.8 percentage of participants |
Secondary
Percentage of Patients That Died at 12 Months.
The Death rate includes Cardiac- & Non-Cardiac Death.
Time frame: 12 months
Population: Intent-to-treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Percentage of Patients That Died at 12 Months. | 1.1 percentage of participants |
| SYNERGY | Percentage of Patients That Died at 12 Months. | 1.1 percentage of participants |
Secondary
Percentage of Patients With a Stroke at 12 Month.
The stroke rate includes: Ischemic- , Hemorraghic- & Undetermined Stroke.
Time frame: 12 months
Population: Intent-to-Treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Percentage of Patients With a Stroke at 12 Month. | 0.9 percentage of participants |
| SYNERGY | Percentage of Patients With a Stroke at 12 Month. | 0.7 percentage of participants |
Secondary
Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.
Time frame: 12 months
Population: Intent-to-treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month. | 5.6 percentage of participants |
| SYNERGY | Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month. | 5.6 percentage of participants |
Secondary
Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.
All CEC adjudicated revascularization at 12 month (Intent to treat population).
Time frame: 12 Month
Population: Intent to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month. | 3.6 percentage of patients |
| SYNERGY | Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month. | 4.0 percentage of patients |
Secondary
Periprocedural Clinical Procedural Success Rate
Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based.
Time frame: Day 1 (periprocedure)
Population: Intent-to-Treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Periprocedural Clinical Procedural Success Rate | 94.3 percentage of subjects |
| SYNERGY | Periprocedural Clinical Procedural Success Rate | 94.9 percentage of subjects |
Secondary
Periprocedural Technical Success Rate.
Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based.
Time frame: Day 1 (periprocedure)
Population: Intent-to-Treat analysis set. Promus Element Plus population: 838 subject analyzed with 1043 lesions treated with technical success achieved in 1011 lesions.~SYNERGY population: 846 subjects analyzed with 1059 lesions treated with technical success achieved in 1041 lesions.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promus Element Plus | Periprocedural Technical Success Rate. | 96.9 percentage of lesions |
| SYNERGY | Periprocedural Technical Success Rate. | 98.3 percentage of lesions |