Post-Approval Study of PROMUS Element™ in China (PEChina)
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Boston Scientific Corporation
First received: August 30, 2012
Last updated: November 6, 2014
Last verified: September 2014
The purpose of this study is to compile real-world clinical outcomes data for the PROMUS Element™ and PROMUS Element™ Plus Everolimus-Eluting Coronary Stent System (PROMUS Element and PROMUS Element Plus Stent System) in routine clinical practice in China.
||Observational Model: Cohort
Time Perspective: Prospective
||PROMUS Element™ China Post-Approval Study
Primary Outcome Measures:
- Target Lesion Failure (TLF) rate [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
The primary endpoint is the 12-month target lesion failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2015 (Final data collection date for primary outcome measure)
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 Stent System (PROMUS Element and PROMUS Element Plus Stent System) after it has been approved by SFDA (State of Food and Drug Administration) in China. The study will evaluate clinical outcomes for subjects receiving the PROMUS Element and PROMUS Element plus stents over 5 years in a real world setting according to post approval requirements from SFDA.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
All subjects who are candidates for coronary artery stenting, signed the informed consent form and eligible to receive a PROMUS Element stent will be evaluated for enrollment in this study.
- 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 is not required in the PROMUS Element China Post-Approval study which is an "all comers" study.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677585
|Second Affliated Hosptial Zhejiang University College of Medicine
|Hangzhou, China |
Boston Scientific Corporation
||Jian'an Wang, Professor
||Second Affliated Hosptial Zhejiang University College of Medicine
No publications provided
||Boston Scientific Corporation
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 30, 2012
||November 6, 2014
||China: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 20, 2014
Coronary Artery Disease
Arterial Occlusive Diseases