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

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Misericordia Hospital

Grosseto, 58100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Prevalence of uncovered struts evaluated by OCT analysis at six-month follow-up.

Time frame: Measured will be assessed six-month after coronary angioplasty

Sponsors and collaborators

Lead sponsor

S.M. Misericordia Hospital

Other

Registry information

Official study title

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

Acronym: DESERT

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Nov 18, 2010
Registry last updated: Jul 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed