Clinical trial NCT02499692: SYNERGY China: Assess SYNERGY Stent in China
Official title: SYNERGY China: A Prospective, Multicenter Trial to Assess the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2015-07-16
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Technical Success Rate
timeFrame: 1 day
Secondary outcomes:
measure: Target Lesion Revascularization (TLR) Rate
timeFrame: 30 days
measure: Target Lesion Failure (TLF) Rate
timeFrame: 30 days
measure: Target Vessel Revascularization (TVR) Rate
timeFrame: 30 days
measure: Target Vessel Failure (TVF) Rate
timeFrame: 30 days
measure: Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: AeroSpace center hospital
city: Changcun
country: China
facility: the second hospital of Jilin Unversity
city: Daqing
country: China
facility: Daqing General Oil Field Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
city: Shenyang
country: China
facility: General Hospital of SY Military Institute
city: Tianjin
country: China
facility: TEDA International Cardiovascular Hospital
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
Study officials:
affiliation: Shenyang Northern Hospital (The General Hospital of Shenyang Military Region)
name: Yalin Han
role: PRINCIPAL_INVESTIGATOR
References: