Research with human participants

Overview of medical research in the Netherlands

PE-Prove Study
PROMUS* Element* Everolimus-Eluting Coronary Stent System
European Post-Approval Surveillance Study
A prospective, open label, multi-center observational study

Published:
Last updated:

Please see pages 3-5 of the Protocol

Download: PDF | XML
Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Coronary artery disorders
Study type
Observational invasive

ID

NL-OMON34092

Source

ToetsingOnline

Brief title

PE-Prove study

Condition

  • Coronary artery disorders

Synonym

Coronary artery disease ; Narrowing of arteries

Research involving

Human

Sponsors and support

Primary sponsor :
Boston Scientific International S.A.
Source(s) of monetary or material Support :
Industry

Intervention

Keyword :
Coronary artery disease, Drug-eluting stent, Percutaneous Transluminal Coronary Angioplasty

Outcome measures

Primary outcome

Please see pages 3-5 of the Protocol

Secondary outcome

Please see pages 3-5 of the Protocol

Background summary

Please see pages 3-5 and 9 of the Protocol

Study objective

Please see pages 3-5 of the Protocol

Study design

Please see pages 3-5 of the Protocol

Study burden and risks

As all procedures are part of the routine care the only risk in participating
in this study is the additional blood test.
The risks associated with providing a blood sample can include fainting, pain
(a painful jab as the needle is inserted into the arm) and/or bruising. In rare
cases, it is also possible for a blood clot to form or for an infection to
occur at the site where the needle was inserted.

Public
Boston Scientific International S.A.

European Headquarters, Paris, 55 Av. Des Champs Pierreux
TSA 51101, 92729 Nanterre Cedex
FR
Scientific
Boston Scientific International S.A.

European Headquarters, Paris, 55 Av. Des Champs Pierreux
TSA 51101, 92729 Nanterre Cedex
FR

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

All patients who are candidates for Coronary artery stenting, signed the Informed Consent Form and are eligible to receive a PROMUS* Element* stent will be evaluated for enrollment in this study.

Exclusion criteria

No study-specific exclusion criteria apart from any contra-indications
Page 20-21 protocol

Design

Study phase :
4
Study type :
Observational invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Other

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
90
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
IRB Nijmegen: Independent Review Board Nijmegen (Wijchen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
IRB Nijmegen: Independent Review Board Nijmegen (Wijchen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
IRB Nijmegen: Independent Review Board Nijmegen (Wijchen)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
ClinicalTrials.gov NCT01148329
CCMO NL33913.072.10