Post-Approval Study of PROMUS Element™ in China
Launched by BOSTON SCIENTIFIC CORPORATION · Aug 30, 2012
Trial Information
Current as of June 13, 2025
Completed
Keywords
ClinConnect Summary
Everolimus-eluting stents have been studied extensively in ongoing clinical studies. The safety and effectiveness of the everolimus drug and polymer combination have been studied extensively in the SPIRIT Clinical Trial Program. The PROMUS Element stent is currently being studied in the PLATINUM Clinical Trial Program. The PROMUS Element stent is also being evaluated in PROMUS Element Plus US post-approval studies and the ongoing Platinum China study. This study is designed to provide post-market surveillance information on the PROMUS Element™ and PROMUS Element™ Everolimus-Eluting Coronary...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Subject must be at least 18 years of age
- • Subject understands and provides written informed consent
- • Subject who is clinically indicated and will have an attempt of at least one PROMUS Element stent OR Subject who is clinically indicated and was implanted with at least one PROMUS Element stent
- • Subject is willing to comply with all protocol-required follow-up evaluation
- Exclusion Criteria:
- • Exclusion criteria is not required in the PROMUS Element China Post-Approval study which is an "all comers" study.
About Boston Scientific Corporation
Boston Scientific Corporation is a global leader in medical device innovation, dedicated to providing solutions that enhance patient care and improve clinical outcomes. With a strong focus on advancing the treatment of various medical conditions, Boston Scientific develops and manufactures a diverse range of products across multiple specialties, including cardiology, urology, and endoscopy. The company is committed to rigorous clinical research and development, ensuring that its devices meet the highest standards of safety and efficacy. Through collaboration with healthcare professionals and ongoing investment in technology and education, Boston Scientific strives to deliver breakthrough therapies that address unmet medical needs and empower patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hangzhou, , China
Patients applied
Trial Officials
Jian'an Wang, Professor
Principal Investigator
Second Affliated Hosptial Zhejiang University College of Medicine
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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