Prospective Registry to Asses the Long-term Safety and Performance of the Combo Stent
Launched by ROBBERT J DE WINTER · Jun 6, 2013
Trial Information
Current as of June 29, 2025
Unknown status
Keywords
ClinConnect Summary
Registry Investigated Device:
The OrbusNeich Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) consists of a 316L stainless steel alloy abluminally coated with a biocompatible, biodegradable polymer containing sirolimus. Covalently attached to this matrix is a layer of murine, monoclonal, anti-human CD34 antibody. The antibody specifically targets CD34+ cells in circulation. Endothelial progenitor cells (EPCs) are CD34+. The stent is supplied premounted on a 0.014" guide wire compatible low profile rapid exchange balloon catheter delivery system. The Combo Stent is Conformitée Eur...
Gender
ALL
Eligibility 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
About Robbert J De Winter
Robbert J. de Winter is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With a focus on innovative methodologies and ethical practices, he spearheads clinical studies that aim to evaluate new therapeutic interventions across various therapeutic areas. His expertise in trial design and execution, coupled with a collaborative approach, fosters partnerships with leading research institutions and healthcare professionals. By prioritizing patient safety and scientific integrity, Robbert J. de Winter plays a pivotal role in the development of groundbreaking treatments that address unmet medical needs.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Breda, , Netherlands
Craigavon, , United Kingdom
Zwolle, , Netherlands
Luxembourg, , Luxembourg
Riga, , Latvia
Nijmegen, , Netherlands
Amsterdam, , Netherlands
Blaricum, , Netherlands
Vigo, , Spain
Patients applied
Trial Officials
Robbert J de Winter, MD, PhD
Principal Investigator
Academic Medical Centre - University of Amsterdam
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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