Post-Approval Study of PROMUS Element™ in China (PEChina)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01677585
First received: August 30, 2012
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to compile real-world clinical outcomes data for the PROMUS Element™ Everolimus-Eluting Coronary Stent System (PROMUS Element Stent System)in routine clinical practice in China.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PROMUS Element™ China Post-Approval Study

Further study details as provided by Boston Scientific Corporation:

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: 2000
Study Start Date: August 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Detailed Description:

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™ Everolimus-Eluting Coronary Stent System (PROMUS ElementStent 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 stents over 5 years in a real world setting according to post approval requirements from SFDA.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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.
  Contacts and Locations
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

Locations
China
Second Affliated Hosptial Zhejiang University College of Medicine
Hangzhou, China
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Jian'an Wang, Professor Second Affliated Hosptial Zhejiang University College of Medicine
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01677585     History of Changes
Other Study ID Numbers: S2288
Study First Received: August 30, 2012
Last Updated: September 2, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014