Study Results
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View full resultsBasic Information
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COMPLETED
NA
103 participants
INTERVENTIONAL
2015-05-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Interventions
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SYNERGYTM Coronary Stent System
SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
75 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Yalin Han
Role: PRINCIPAL_INVESTIGATOR
Shenyang Northern Hospital (The General Hospital of Shenyang Military Region)
Locations
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AeroSpace center hospital
Beijing, , China
the second hospital of Jilin Unversity
Changcun, , China
Daqing General Oil Field Hospital
Daqing, , China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, , China
The First Hospital of Lanzhou University
Lanzhou, , China
General Hospital of SY Military Institute
Shenyang, , China
TEDA International Cardiovascular Hospital
Tianjin, , China
Wuhan Asia Heart Hospital
Wuhan, , China
Countries
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Other Identifiers
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S2342
Identifier Type: -
Identifier Source: org_study_id
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