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

NCT01243099 | Completed

• 1 other identifier: DSR-01
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of uncovered struts evaluated by OCT analysis at six-month follow-up.

  Measured will be assessed six-month after coronary angioplasty

Study Arms (2)

In-stent (BMS) restenosis

De-novo coronary lesion

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• S.M. Misericordia Hospital: lead

Study Sites (1)

Misericordia Hospital

Grosseto, 58100, Italy

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md. PhD

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 18, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 23, 2013

Record last verified: 2013-07

Locations

IT (1)