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Late Acquired Malaposition and Different Polymers

NCT ID: NCT02018991

Last Updated: 2013-12-30

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-08-31

Brief Summary

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The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM) with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM in DES with newer-generation polymers designed to improve biocompatibility are unknown.

Detailed Description

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please see brief summary

Conditions

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Late Acquired Stent Malaposition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Everolimus-Eluting-Stent (EES)

Patients treated with EES

Group Type ACTIVE_COMPARATOR

Everolimus-Eluting Stent (EES)

Intervention Type PROCEDURE

Patients treated with EES

Zotarolimus-Eluting-Stent (ZES)

Patients treated with ZES

Group Type ACTIVE_COMPARATOR

Zotarolimus-Eluting-Stent (ZES)

Intervention Type PROCEDURE

Patients treated with ZES

Biolimus-Eluting-Stent (BES)

Patients treated with BES

Group Type ACTIVE_COMPARATOR

Biolimus-Eluting-Stent (BES)

Intervention Type PROCEDURE

Patients treated with BES

Interventions

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Everolimus-Eluting Stent (EES)

Patients treated with EES

Intervention Type PROCEDURE

Zotarolimus-Eluting-Stent (ZES)

Patients treated with ZES

Intervention Type PROCEDURE

Biolimus-Eluting-Stent (BES)

Patients treated with BES

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who underwent an elective treatment of a coronary lesion \> 20mm with a DES

Exclusion Criteria

* chronic renal failure (serum creatinine ≥ 2.5mg/dl)
* restenotic lesions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Univ. Prof. Dr. Thomas Neunteufl

Univ. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Neunteufl, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

PI

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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MUW-0001

Identifier Type: -

Identifier Source: org_study_id