N/A
Completed N=103
SYNERGY China: Assess SYNERGY Stent in China
Source: ClinicalTrials.gov NCT02499692 ↗Enrolled (actual)
103
Serious AEs
1.0%
Results posted
Jan 2016
Primary outcomePrimary: Technical Success Rate — 98.1 percentage of participants
Summary
Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites across China, the primary endpoint is Technical success.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Technical Success Rate |
98.1 | — |
| SECONDARY Target Lesion Revascularization (TLR) Rate |
— | — |
| SECONDARY Target Lesion Failure (TLF) Rate |
— | — |
| SECONDARY Target Vessel Revascularization (TVR) Rate |
— | — |
| SECONDARY Target Vessel Failure (TVF) Rate |
— | — |
| SECONDARY Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate |
— | — |
Eligibility Criteria
Key Inclusion Criteria
- Subject must be at least 18 -75 years of age
- Subject is eligible for percutaneous coronary intervention (PCI)
- 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 1
Key Exclusion Criteria
- Planned PCI (including staged procedures) or CABG after the index procedure
- Subject with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant.
- Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
- 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
- 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.
- 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
Data sourced from ClinicalTrials.gov (NCT02499692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.