Clinical Trials Directory

Trials / Completed

CompletedNCT01243099

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

Des Re-Endothelization for In-StEnt ResTenosis. The DESERT Study

Status
Completed
Phase
Study type
Observational
Enrollment
31 (actual)
Sponsor
S.M. Misericordia Hospital · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2010-11-01
Primary completion
2013-01-01
Completion
2013-07-01
First posted
2010-11-18
Last updated
2013-07-23

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01243099. Inclusion in this directory is not an endorsement.