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

Stable Coronary Artery Disease Clinical Trial

— DESERT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243099
• Other study ID #: DSR-01
• Status: Completed
• Phase: N/A
• First received: November 15, 2010
• Last updated: July 22, 2013
• Start date: November 2010
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: S.M. Misericordia Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Italy	Misericordia Hospital	Grosseto

Sponsors (1)

Lead Sponsor	Collaborator
S.M. Misericordia Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of uncovered struts evaluated by OCT analysis at six-month follow-up.		Measured will be assessed six-month after coronary angioplasty	No