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

July 22, 2013 updated by: Andrea Picchi, S.M. Misericordia Hospital

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Grosseto, Italy, 58100
        • Misericordia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Paziente affected by either stable coronary artery disease or silent myocardial ischemia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
In-stent (BMS) restenosis
De-novo coronary lesion

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S.M. Misericordia Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

November 15, 2010

First Submitted That Met QC Criteria

November 17, 2010

First Posted (Estimate)

November 18, 2010

Study Record Updates

Last Update Posted (Estimate)

July 23, 2013

Last Update Submitted That Met QC Criteria

July 22, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSR-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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