Late Acquired Malaposition and Different Polymers

Phase 4

Completed

• Conditions: Late Acquired Stent Malaposition
• Interventions: Procedure: Everolimus-Eluting Stent (EES); Procedure: Zotarolimus-Eluting-Stent (ZES); Procedure: Biolimus-Eluting-Stent (BES)

• Registration Number: NCT02018991
• Lead Sponsor: Medical University of Vienna

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-12
• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-24
• Last Update Submitted: 2013-12-26
• Last Update Posted: 2013-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

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

Read More

Exclusion Criteria

• chronic renal failure (serum creatinine ≥ 2.5mg/dl)
• restenotic lesions

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Everolimus-Eluting-Stent (EES)	Everolimus-Eluting Stent (EES)	Patients treated with EES
Zotarolimus-Eluting-Stent (ZES)	Zotarolimus-Eluting-Stent (ZES)	Patients treated with ZES
Biolimus-Eluting-Stent (BES)	Biolimus-Eluting-Stent (BES)	Patients treated with BES

Primary Outcome Measures

Name	Time	Method
Number of stent struts with late acquired malaposition	1 year after stent implantation

Secondary Outcome Measures

Name	Time	Method
number of stent struts with late acquired malaposition	2 years after stent implantation

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria