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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01243099
Recruitment Status : Completed
First Posted : November 18, 2010
Last Update Posted : July 23, 2013
Information provided by (Responsible Party):
Andrea Picchi, S.M. Misericordia Hospital

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.

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

Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Des Re-Endothelization for In-StEnt ResTenosis. The DESERT Study
Study Start Date : November 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : July 2013

In-stent (BMS) restenosis
De-novo coronary lesion

Primary Outcome Measures :
  1. Prevalence of uncovered struts evaluated by OCT analysis at six-month follow-up. [ Time Frame: Measured will be assessed six-month after coronary angioplasty ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Paziente affected by either stable coronary artery disease or silent myocardial ischemia

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01243099

Misericordia Hospital
Grosseto, Italy, 58100
Sponsors and Collaborators
S.M. Misericordia Hospital

Responsible Party: Andrea Picchi, Md. PhD, S.M. Misericordia Hospital Identifier: NCT01243099     History of Changes
Other Study ID Numbers: DSR-01
First Posted: November 18, 2010    Key Record Dates
Last Update Posted: July 23, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes