NCT01677585

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,016

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

3.3 years

First QC Date

August 30, 2012

Last Update Submit

February 23, 2022

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Target Lesion Failure (TLF) rate

    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.

    12-month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affliated Hosptial Zhejiang University College of Medicine

Hangzhou, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jian'an Wang, Professor

    Second Affliated Hosptial Zhejiang University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 3, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2019

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)