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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	18 January 2016
Main ID:	NCT01874002
Date of registration:	06/06/2013
Prospective Registration:	No
Primary sponsor:	Robbert J de Winter
Public title:	Prospective Registry to Asses the Long-term Safety and Performance of the Combo Stent REMEDEE Reg
Scientific title:	Multicenter, Prospective, Clinical Outcomes After Deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio- Engineered Sirolimus Eluting Stent) Post Market Registry
Date of first enrolment:	June 2013
Target sample size:	1000
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/show/NCT01874002
Study type:	Observational [Patient Registry]
Study design:	Observational Model: Cohort, Time Perspective: Prospective
Phase:	N/A

Countries of recruitment
Latvia	Luxembourg	Netherlands	Spain	United Kingdom

Contacts

Name:	Robbert J de Winter, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Academic Medical Centre - University of Amsterdam

Key inclusion & exclusion criteria

Inclusion Criteria:

- Consecutive patients eligible for Combo stent placement by percutaneous coronary
intervention are included in the REMEDEE REGISTRY

Exclusion Criteria:

- High probability of non-adherence to the follow-up requirements (due to social,
psychological or medical reasons)

- Currently participating in another investigational drug or device study in which a
routine angiographic follow-up is planned

- A life expectancy of <1 year

- Explicit refusal of participation in the registry

Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Intervention(s)

Device: Combo stent

Primary Outcome(s)

Adjudicated Target Lesion Failure [Time Frame: 1 year post-procedure]

Secondary Outcome(s)

Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) [Time Frame: 3 years post-procedure]

Adjudicated stent thrombosis (definite/probable/possible) [Time Frame: 3 years post-procedure]

Individual components of target lesion failure (TLF) [Time Frame: 180 days post-procedure]

Procedure success [Time Frame: Procedural]

Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) [Time Frame: 2 years post-procedure]

Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) [Time Frame: 1 year post-procedure]

Adjudicated Target Lesion Failure [Time Frame: 180 days post procedure]

Adjudicated Target Lesion Failure [Time Frame: 2 years post-procedure]

Adjudicated Target Lesion Failure [Time Frame: 3 years post-procedure]

Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) [Time Frame: 180 days post-procedure]

Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) [Time Frame: 5 years post-procedure]

Adjudicated stent thrombosis (definite/probable/possible) [Time Frame: 2 years post-procedure]

Individual components of target lesion failure (TLF) [Time Frame: 3 years post-procedure]

Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) [Time Frame: 30 days post-procedure]

Adjudicated stent thrombosis (definite/probable/possible) [Time Frame: 180 days post-procedure]

Individual components of target lesion failure (TLF) [Time Frame: 4 years post-procedure]

Individual components of target lesion failure (TLF) [Time Frame: 5 years post-procedure]

Adjudicated stent thrombosis (definite/probable/possible) [Time Frame: 30 days post-procedure]

Adjudicated Target Lesion Failure [Time Frame: 30 days post-procedure]

Adjudicated stent thrombosis (definite/probable/possible) [Time Frame: 4 years post-procedure]

Adjudicated stent thrombosis (definite/probable/possible) [Time Frame: 5 years post-procedure]

Adjudicated Target Lesion Failure [Time Frame: 4 years post-procedure]

Adjudicated Target Lesion Failure [Time Frame: 5 years post-procedure]

Each of the individual components of Major Adverse Cardiac Events(MACE) [Time Frame: 1 year post-procedure]

Individual components of target lesion failure (TLF) [Time Frame: 2 years post-procedure]

Device success [Time Frame: Procedural]

Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) [Time Frame: 4 years post-procedure]

Adjudicated stent thrombosis (definite/probable/possible) [Time Frame: 1 year post-procedure]

Individual components of target lesion failure (TLF) [Time Frame: 1 year post-procedure]

Individual components of target lesion failure (TLF) [Time Frame: 30 days post-procedure]

Secondary ID(s)

Version 2.0

W12_186

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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