Late Acquired Malaposition and Different Polymers | NCT02018991

Studies
Late Acquired Malaposition and Different Polymers

NCT02018991

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Dec 30, 2013Estimated

Enrollment

69Actual

Phase

Phase 4

Conditions

Late Acquired Stent Malaposition

Interventions

Everolimus-Eluting Stent (EES)
Zotarolimus-Eluting-Stent (ZES)
Biolimus-Eluting-Stent (BES)

Countries

Austria

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

Dec 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

Oct 2010

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Dec 17, 2013

First Submission Date that Met QC Criteria

Dec 17, 2013

First Posted Date

Dec 24, 2013Estimated

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

Dec 26, 2013

Last Update Posted Date

Dec 30, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Univ. Prof. Dr. Thomas Neunteufl, Univ. Prof. Dr., Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

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 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

please see brief summary

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Everolimus-Eluting-Stent (EES)	Active Comparator	Patients treated with EES	Procedure: Everolimus-Eluting Stent (EES)
Zotarolimus-Eluting-Stent (ZES)	Active Comparator	Patients treated with ZES	Procedure: Zotarolimus-Eluting-Stent (ZES)
Biolimus-Eluting-Stent (BES)	Active Comparator	Patients treated with BES	Procedure: Biolimus-Eluting-Stent (BES)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Everolimus-Eluting Stent (EES)	Procedure	Patients treated with EES	Everolimus-Eluting-Stent (EES)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of stent struts with late acquired malaposition		1 year after stent implantation

Secondary Outcomes

Measure	Description	Time Frame
number of stent struts with late acquired malaposition		2 years after stent implantation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Neunteufl, Prof. Dr.	PI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna		Vienna		1090	Austria