Prospective Study to Assess DES Re-endothelization in BMS... | NCT01243099

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

NCT01243099

Sponsor

S.M. Misericordia Hospital

Status

Completed

Last Update Posted

Jul 23, 2013Estimated

Enrollment

31Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Jan 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Nov 15, 2010

First Submission Date that Met QC Criteria

Nov 17, 2010

First Posted Date

Nov 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2013

Last Update Posted Date

Jul 23, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Misericordia Hospital		Grosseto		58100	Italy

Label	Type	Description	Intervention Names
In-stent (BMS) restenosis
De-novo coronary lesion