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NCT01670318

Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets

Last Updated: 2012-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-12-31

Brief Summary

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Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left main trunk disease, and small vessel diseases is still unknown.

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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Chronic total occlusion Bifurcation lesion Left main trunk lesion Small vessel disease Multi vessel disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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platinum chromium everolimus-eluting stent

Group Type EXPERIMENTAL

platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)

Intervention Type DEVICE

Interventions

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platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome
2. Male or non-pregnant female

1. Multi-vessel diseases
2. Long lesion (lesion length \>30mm by visual estimation)
3. Small vessel disease (reference diameter \<2.5mm by visual estimation)
4. Bifurcation lesion
5. Ostial lesion
6. Calcified lesion
7. Protected or non-protected left main trunk disease
8. Chronic total occlusion
9. In stent restenosis of bare metal stent or everolimus-eluting stent

Exclusion Criteria

1. Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine, clopidogrel or X-ray contrast media.
2. Serum creatinine level \>3.0 mg/dL
3. Other concomitant disease or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis or cancer within 5 years.

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuji Oikawa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cardiovascular Institute

Kenya Nasu, MD, FACC

Role: PRINCIPAL_INVESTIGATOR

Toyohashi Heart Center

Locations

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