Clincosm LogoSign in Get a demo

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

Sponsor
S.M. Misericordia Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01243099
Collaborator
(none)
31
Enrollment
1
Location
32
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Nov 1, 2010
    Actual Primary Completion Date :
    Jan 1, 2013
    Actual Study Completion Date :
    Jul 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    In-stent (BMS) restenosis
    De-novo coronary lesion

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Misericordia Hospital Grosseto Italy 58100

    Sponsors and Collaborators

    • S.M. Misericordia Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrea Picchi, Md. PhD, S.M. Misericordia Hospital
    ClinicalTrials.gov Identifier:
    NCT01243099
    Other Study ID Numbers:
    • DSR-01
    First Posted:
    Nov 18, 2010
    Last Update Posted:
    Jul 23, 2013
    Last Verified:
    Jul 1, 2013
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Ischemia

    Study Results

    No Results Posted as of Jul 23, 2013