Brief Summary

The superiority of a percutaneous coronary intervention (PCI) by one stent over another in terms of clinical outcome is usually documented in large randomized controlled trials (RCT). Although generated from selected study populations these data form the basis for evidence based practice (EBP) in the entire population of patients considered for coronary intervention. An inherent limitation of this approach is that study populations differ significantly from all comers in terms of patient characteristics and prognosis undermining the foundation for extrapolation of trial results to all comers. Furthermore, other trials are based on a "one-fits-all" concept, while the benefits of an "individual-tailored" approach that might be superior, is not investigated. The Purpose of the current study is to

Compare clinical outcome between several CE marked drug eluting stents
Compare clinical outcome between several CE marked bare metal stents
Compare clinical outcome in all comers with that of the selected study population of RCT's
Evolve methods to compare clinical outcomes between the generalized "one-fits-all" versus the individualized or "individual-tailored" stent selection approaches The Method employed is
All comer PCI registry - single centre
Randomisation of all eligible patients within the registry to one of several study stent
Quality assurance in non-randomized population within the registry by periodical alternating the institutional standard stent
Continuous follow up of all patients included the registry by means of systematic event detection and classification by an independent safety and end point committee
Assessment of effects on quality of life by heart and health questionnaires Outcome Measures Primary endpoints:
Composite of cardiac death, acute myocardial infraction and target vessel revascularisation
Stent thrombosis
A specifically developed Treatment Failure Rate classification Secondary outcome measures include each of the above, target lesion revascularisation and total death analyzed in a hierarchical fashion at 2, 3, 4 and 5 years. Tertiary outcome measure is self reported quality of life based on health questionnaires on general health and cardiac symptoms. Power Calculations An event rate of 20% within 5 years, a relative difference of 25% (an absolute difference of 5%), P\< 5%, Power \> 80% =\> 900 patients in each of two treatment arms. Prespecified Analysis include
The MACE rates between stent types
The Stent thrombosis rates between stent types
The Treatment failure rates between stent types
The randomized population versus non-randomized population
The individualized versus the generalized Population
QOL between stent types

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

5,100

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Mar 2012

Longer than P75 for phase_4

Geographic Reach

1 country

1 active site

Status

unknown

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

9 years study duration

First Submitted

Initial submission to the registry

January 30, 2012

Completed

17 days until next milestone

First Posted

Study publicly available on registry

February 16, 2012

Completed

14 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed

8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed

Last Updated

February 16, 2012

Status Verified

February 1, 2012

Enrollment Period

8 years

First QC Date

January 30, 2012

Last Update Submit

February 15, 2012

Conditions

Ischemic Heart Disease

Keywords

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (3)

MACE
Major adverse cardiac events defined as a composite of cardiac death, acute myocardial infraction and target vessel revascularisation
Five year
Stent thromboses
Definite, propable and possible
Five year
Treatment failure
A specifically developed Treatment Failure Classification
Five Years

Secondary Outcomes (8)

Death of any cause
One and five years
Self reported health questionnaires on general health and cardiac specific symptoms.
One and five years
Cardiac death
One and five years
Myocardial infarction
One and five years
Target lesion revascularisation
One and five years
+3 more secondary outcomes