NCT02029092

Brief Summary

This registry is a clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
404

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

14 active sites

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

First Submitted

Initial submission to the registry

December 19, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
25 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

2.4 years

First QC Date

December 19, 2013

Last Update Submit

September 26, 2017

Conditions

Coronary Artery Disease

Keywords

InternationalMulticenterObservational registryOrsiro Drug Eluting Stent (DES)StentingTreatment of coronary artery diseaseCoronary revascularizationPercutaneous Coronary Intervention (PCI)STEMINSTEMIIschemiaAnginaAcute Myocardial Infarction (AMI)Small VesselsChronical Total Occlusion (CTO)

Outcome Measures

Primary Outcomes (1)

  • Target Lesion Failure (TLF)

    Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR).

    12 months

Secondary Outcomes (6)

  • TLF

    6 months

  • Target Vessel Revascularization (TVR)

    6 and 12 months

  • Target lesion revascularization (TLR)

    6 and 12 months

  • Stent Thrombosis rate

    6 and 12 months

  • Device success

    up to discharge

  • +1 more secondary outcomes

Study Arms (1)

Orsiro

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects requiring coronary revascularization with Drug Eluting Stents (DES)

You may qualify if:

  • Symptomatic coronary artery disease
  • Subject has signed informed consent for data release
  • Subject is geographically stable and willing to participate at all follow up assessments
  • Subject is≥18 years of age.

You may not qualify if:

  • Subject did not sign informed consent for data release
  • Pregnancy
  • Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation, antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media.
  • Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
  • Currently participating in another study and primary endpoint is not yet reached.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hospital Universitario León

León, A/Altos de Nava S/n, 24080, Spain

Location

Hospital Infanta Cristina

Badajoz, Spain

Location

Hospital Vall D' Hebron

Barcelona, Spain

Location

Hospital G.de Jerez de la Frontera

Cadiz, Spain

Location

Hospital de Mérida

Mérida, Spain

Location

Hospital Univ. Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Parc Tauli

Sabadell, Spain

Location

Complejo de Hospitalario de Santiago

Santiago de Compostela, 15702, Spain

Location

Hospital Virgen del Rocio

Seville, Spain

Location

Hospital Mutua de Terrassa

Terrassa, Spain

Location

Hospital Clinico de Valencia

Valencia, Spain

Location

Hospital Doctor Peset

Valencia, Spain

Location

Hospital de Txagorritxu

Vitoria-Gasteiz, Spain

Location

Hospital de Cruces

Vizcaya, 48903, Spain

Location

MeSH Terms

Conditions

Coronary Artery DiseaseST Elevation Myocardial InfarctionNon-ST Elevated Myocardial InfarctionIschemiaAngina Pectoris

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMyocardial InfarctionInfarctionPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sonia Martin

    CEM BIOTRONIK SA

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2013

First Posted

January 7, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 28, 2017

Record last verified: 2017-09

Locations

ES(14)