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

NCT ID: NCT01243099

Last Updated: 2013-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-07-31

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

In-stent (BMS) restenosis

No interventions assigned to this group

De-novo coronary lesion

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S.M. Misericordia Hospital

OTHER

Sponsor Role: lead

Responsible Party

Andrea Picchi

Md. PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Misericordia Hospital

Grosseto, , Italy

Countries

Italy

Other Identifiers

DSR-01

Identifier Type: -

Identifier Source: org_study_id