NCT02018991

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
Last Updated

December 30, 2013

Status Verified

December 1, 2013

Enrollment Period

2.8 years

First QC Date

December 17, 2013

Last Update Submit

December 26, 2013

Conditions

Late Acquired Stent Malaposition

Outcome Measures

Primary Outcomes (1)

  • Number of stent struts with late acquired malaposition

    1 year after stent implantation

Secondary Outcomes (1)

  • number of stent struts with late acquired malaposition

    2 years after stent implantation

Study Arms (3)

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

Everolimus-Eluting Stent (EES)PROCEDURE

Patients treated with EES

Everolimus-Eluting-Stent (EES)
Zotarolimus-Eluting-Stent (ZES)PROCEDURE

Patients treated with ZES

Zotarolimus-Eluting-Stent (ZES)
Biolimus-Eluting-Stent (BES)PROCEDURE

Patients treated with BES

Biolimus-Eluting-Stent (BES)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Study Officials

  • Thomas Neunteufl, Prof. Dr.

    PI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ. Prof. Dr.

Study Record Dates

First Submitted

December 17, 2013

First Posted

December 24, 2013

Study Start

October 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 30, 2013

Record last verified: 2013-12

Locations

AU(1)