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Endothelial Progenitor Cells-capture Stents in Acute Coronary Syndromes

NCT00494247 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-06-22

No results posted yet for this study

Summary

Randomized prospective study to compare the efficiency and safety of EPC-capture stents (Genous, OrbusNeich) and bare metal stents with concommitant high dose atorvastatin in reduction of neointimal formation assessed by quantitative coronary angiography and IVUS. Also the association between the function (transcriptional activity, migration) and number of circulating EPCs and angiographic outcomes will be investigated.

Conditions

Interventions

DEVICE

coronary stent (Genous, OrbusNeich) with immobilised anti-CD34 antibody to capture circulating endothelial progenitor cells

coronary stent covered with anti-CD34 antobody, (Genous, R-stent, produced by OrbusNeich). 30 patients will undergo PCI with implantation of Genous stent and 30 patients will receive bare metal stent (BMS)

Sponsors & Collaborators

  • Ministry of Science and Higher Education, Poland

    collaborator OTHER_GOV

  • Silesian School of Medicine

    lead OTHER

Principal Investigators

  • Wojciech Wojakowski, MD, PhD · Silesian School of Medicine, Katowice, Poland

  • Michal Tendera, MD, PhD · Silesian School of Medicine, Katowice, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-06-30
Completion
2009-08-31

Countries

  • Poland

Study Locations

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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 NCT00494247 on ClinicalTrials.gov