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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrea Picchi, S.M. Misericordia Hospital
ClinicalTrials.gov Identifier:
NCT01243099
First received: November 15, 2010
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Des Re-Endothelization for In-StEnt ResTenosis. The DESERT Study

Resource links provided by NLM:


Further study details as provided by S.M. Misericordia Hospital:

Primary Outcome Measures:
  • Prevalence of uncovered struts evaluated by OCT analysis at six-month follow-up. [ Time Frame: Measured will be assessed six-month after coronary angioplasty ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: November 2010
Study Completion Date: July 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
In-stent (BMS) restenosis
De-novo coronary lesion

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243099

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

No publications provided

Responsible Party: Andrea Picchi, Md. PhD, S.M. Misericordia Hospital
ClinicalTrials.gov Identifier: NCT01243099     History of Changes
Other Study ID Numbers: DSR-01
Study First Received: November 15, 2010
Last Updated: July 22, 2013
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on April 15, 2014