Cardiovascular Diseases
Conditions
Brief summary
Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites across China, the primary endpoint is Technical success.
Detailed description
The study is To evaluate clinical and peri-procedural angiographic outcomes for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary 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
DEVICESYNERGYTM Coronary Stent System
SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Subject must be at least 18 -75 years of age 2. Subject is eligible for percutaneous coronary intervention (PCI) 3. 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, 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 Key
Exclusion criteria
1. Planned PCI (including staged procedures) or CABG after the index procedure 2. Subject with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant. 3. Subject is on dialysis or has baseline serum creatinine level \>2.0 mg/dL (177µmol/L) 4. Planned treatment of more than 3 lesions, Planned treatment of lesions in more than 2 major epicardial vessels, Planned treatment of a single lesion with more than 1 stent 5. Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate. 6. Target vessel develops a dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C following the pre-dilatation/pre-treatment of the first target lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success Rate | 1 day | Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of \<30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician |
Secondary
| Measure | Time frame |
|---|---|
| Target Lesion Revascularization (TLR) Rate | 30 days |
| Target Lesion Failure (TLF) Rate | 30 days |
| Target Vessel Revascularization (TVR) Rate | 30 days |
| Target Vessel Failure (TVF) Rate | 30 days |
| Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate | 30 days |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SYNERGYTM Coronary Stent System Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System
SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System | 103 |
| Total | 103 |
Baseline characteristics
| Characteristic | SYNERGYTM Coronary Stent System |
|---|---|
| Age, Continuous | 58.92 years STANDARD_DEVIATION 8.74 |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 103 |
| serious Total, serious adverse events | 1 / 103 |
Outcome results
Primary
Technical Success Rate
Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of \<30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYNERGYTM Coronary Stent System | Technical Success Rate | 98.1 percentage of participants |
Secondary
Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYNERGYTM Coronary Stent System | Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate | 0 percentage of participants |
Secondary
Target Lesion Failure (TLF) Rate
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYNERGYTM Coronary Stent System | Target Lesion Failure (TLF) Rate | 0 percentage of participants |
Secondary
Target Lesion Revascularization (TLR) Rate
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYNERGYTM Coronary Stent System | Target Lesion Revascularization (TLR) Rate | 0 percentage of participants |
Secondary
Target Vessel Failure (TVF) Rate
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYNERGYTM Coronary Stent System | Target Vessel Failure (TVF) Rate | 0 percentage of participants |
Secondary
Target Vessel Revascularization (TVR) Rate
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYNERGYTM Coronary Stent System | Target Vessel Revascularization (TVR) Rate | 0 percentage of participants |