Atherosclerotic Lesion(s)
Conditions
Keywords
Drug-eluting stents
Brief summary
The purpose of this study is to evaluate 9 month angiographic and intravascular ultrasound (IVUS) data for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) in 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).
Interventions
DEVICESYNERGY
Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating.
Sponsors
Beth Israel Deaconess Medical Center
Medstar Health Research Institute
Quintiles, Inc.
Medidata Solutions
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 pre-dilated/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 (clopidogrel, ticlopidine, prasugrel, or ticagrelor), 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., New York Heart Association (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 |
|---|---|---|
| In-stent Late Loss | 9 month | In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA) |
Countries
Australia, Japan, New Zealand, Singapore
Participant flow
Recruitment details
A total of 100 subjects were enrolled at 12 centers in Australia, New Zealand, Singapore and Japan between March 25, 2013 and October 15, 2013.
Participants by arm
| Arm | Count |
|---|---|
| SYNERGY Stent System SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)
SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | SYNERGY Stent System |
|---|---|
| Age, Continuous | 64.49 years STANDARD_DEVIATION 10.21 |
| Cardiac Risk Factors Current Diabetes Mellitus; Medically Treated | 17 participants |
| Cardiac Risk Factors Family History of Coronary Artery Disease | 57 participants |
| Cardiac Risk Factors History of Myocardial Infarction | 18 participants |
| Cardiac Risk Factors History of PCI | 33 participants |
| Cardiac Risk Factors Hyperlipidemia Requiring Medication | 90 participants |
| Cardiac Risk Factors Hypertension Requiring Medication | 71 participants |
| Lesion Characteristics Lesion Length | 14.38 mm STANDARD_DEVIATION 7.49 |
| Lesion Characteristics Minimum Lumen Diameter | 0.86 mm STANDARD_DEVIATION 0.28 |
| Lesion Characteristics Percent Diameter Stenosis | 67.54 mm STANDARD_DEVIATION 9.59 |
| Lesion Characteristics Reference Vessel Diameter | 2.66 mm STANDARD_DEVIATION 0.46 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants |
| Race/Ethnicity, Customized Asian | 28 participants |
| Race/Ethnicity, Customized Black, of African Heritage | 0 participants |
| Race/Ethnicity, Customized Caucasian | 70 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islader | 0 participants |
| Race/Ethnicity, Customized Not disclosed | 0 participants |
| Race/Ethnicity, Customized Other | 2 participants |
| Region of Enrollment Australia | 10 participants |
| Region of Enrollment Japan | 10 participants |
| Region of Enrollment New Zealand | 69 participants |
| Region of Enrollment Singapore | 11 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 73 / 100 |
| serious Total, serious adverse events | 38 / 100 |
Outcome results
Primary
In-stent Late Loss
In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA)
Time frame: 9 month
Population: The primary endpoint would be considered to have been met if the SYNERGY in-stent late loss was less than the performance goal of 0.40 mm. The Intent To Treat (ITT) and per protocol populations were identical.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SYNERGY Stent System | In-stent Late Loss | 0.23 mm |