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Prospective Registry to Asses the Long-term Safety and Performance of the Combo Stent

NCT01874002 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2015-12-30

No results posted yet for this study

Summary

Patients with stenosis in one or more coronary artery are often treated with a percutaneous coronary intervention (PCI). As part of the PCI treatment a stent is often placed to keep the vessel open over time.

The Combo-Stent is a novel stent for use during percutaneous angioplasty. In short, the Combo stent combines a drug eluting technique and an endothelial cell attracting layer. The drug coating is designed to prevent re-narrowing of the stent. The endothelial cell attracting layer is designed to ensure rapid coverage of the stent struts with vascular wall cells.

The REMEDEE REGISTRY evaluates the long-term safety and performance of the Combo stent in routine clinical practice. In total 1000 patients will be registered and followed for five years.

Conditions

Interventions

DEVICE

Combo stent

Percutaneous coronary intervention of patients with an indication for stent treatment with the COMBO stent, a stent with an endothelial progenitor cell attracting coating and abluminal sirolimus matrix. All consecutive patients treated with, or attempted treatment with, a COMBO stent are followed by telephone contact for 5 years.

Sponsors & Collaborators

  • Robbert J de Winter

    lead OTHER

Principal Investigators

  • Robbert J de Winter, MD, PhD · Academic Medical Centre - University of Amsterdam

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-03-31
Completion
2019-03-31

Countries

  • Latvia
  • Luxembourg
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01874002 on ClinicalTrials.gov