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Prospective Study to Assess DES Re-endothelization in BMS Restenosis and De-novo Lesions

NCT01243099 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2013-07-23

No results posted yet for this study

Summary

The hypothesis of this study is that strut coverage occurs earlier when a DES is implanted to treat a BMS restenosis compared with atherosclerotic de-novo lesion. This hypothesis is supported by two different observations: first, when a DES is implanted to treat a BMS restenosis, stent struts are deployed and drugs are eluted on a soft tissue mostly characterized by extracellular matrix with a regular surface. In this case stent malposition is less likely to occur compared to atherosclerotic lesion whose surface is often more irregular and rich in calcium. Second, patients who develop in-stent restenosis after BMS implantation are likely to show a more pronounced neointima hyperplasia and, when a DES is implanted to treat restenosis, reendothelialization is likely to occur earlier. If this hypothesis was verified, duration of dual antiplatelet therapy could be shortened after DES implantation on BMS restenosis with a clinical advantage in terms of bleeding risk. Furthermore, a higher bleeding risk is often a reason for choosing a BMS instead of a DES; thus, patients presenting with BMS restenosis are likely to have a higher bleeding risk and to benefit from a shorter period of dual antiplatelet therapy.

Conditions

  • Stable Coronary Artery Disease
  • Silent Myocardial Ischemia
  • In-stent(BMS)Restenosis
  • De-novo, Atherosclerotic, Coronary Lesions

Sponsors & Collaborators

  • S.M. Misericordia Hospital

    lead OTHER

Eligibility

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

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-01-31
Completion
2013-07-31

Countries

  • Italy

Study Locations

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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 NCT01243099 on ClinicalTrials.gov