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

Completed

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

• Registration Number: NCT01243099
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-18
• Primary Completion: 2013-01
• Status Verified: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-22
• Last Update Posted: 2013-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of uncovered struts evaluated by OCT analysis at six-month follow-up.	Measured will be assessed six-month after coronary angioplasty

Trial Locations

Locations (1)

Misericordia Hospital; 🇮🇹 Grosseto, Italy