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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01243099
Acronym
DESERT
Enrollment
31
Registered
2010-11-18
Start date
2010-11-30
Completion date
2013-07-31
Last updated
2013-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

None listed

Sponsors

S.M. Misericordia Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Patients suitable for implantation of everolimus-eluting stents (Xcience V, Xience Prime) because of stable/unstable angina or silent myocardial ischemia due to: * Group A: single BMS restenosis (\> 50% of luminal diameter) * Group B: single de-novo lesion (\> 50% of luminal diameter)

Exclusion criteria

* contraindications to dual antiplatelet therapy * acute myocardial infarction within the previous 48 hours * significant left main coronary artery disease * reference vessel diameter \< 2.5 mm, * hemodynamic instability * chronic kidney disease with serum creatinine \> 2 mg/dl * pregnancy * allergy to contrast agent, everolimus, aspirin, clopidogrel * life expectancy \< 24 months * patients with possible low adherence to medical therapy

Design outcomes

Primary

MeasureTime frame
Prevalence of uncovered struts evaluated by OCT analysis at six-month follow-up.Measured will be assessed six-month after coronary angioplasty

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026