NCT02028728

Brief Summary

Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry. The sample size maybe increased in order to reach the subgroup sizes (Diabetes, small vessel, AMI and CTO).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
609

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

Geographic Reach
1 country

18 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
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.3 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

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

2.3 years

First QC Date

December 19, 2013

Last Update Submit

September 28, 2017

Conditions

Coronary Artery Diseases

Keywords

InternationalMulticenterObservational registryOrsiro Drug Eluting Stent (DES)StentingTreatment of coronary artery diseaseCoronary revascularizationPercutaneous Coronary Intervention (PCI)STEMINSTEMIIschemiaAnginaAcute Myocardial Infarction (AMI)Small VesselsChronic 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 and 18 months

  • Target Vessel Revascularization (TVR)

    6, 12 and 18 months

  • Target Lesion Revascularization (TLR)

    6, 12 and 18 months

  • Stent Thrombosis

    6, 12 and 18 months

  • Clinical 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 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
  • Pregnancy
  • Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any other anticoagulant/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 not reached yet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Ospedale Sant'Anna

San Fermo della Battaglia, Como, Italy

Location

Cardiologia Ospedaliera Policlinico Bari

Bari, Italy

Location

Cardiologia Universitaria Policlinico Bari

Bari, Italy

Location

Clinical Santa Maria

Bari, Italy

Location

Ospedale Di Venere

Bari, Italy

Location

Policlinico Conzorciale di Bari

Bari, Italy

Location

P.O. Cardarelli

Campobasso, Italy

Location

Azienda Ospedaliera Pugliese-Ciaccio

Catanzaro, Italy

Location

Ospedale F. Veneziale

Isernia, Italy

Location

A.O. Ospedale Civile Legnano

Legnano, Italy

Location

AO Ospedale Civile Legnano, Fornaroli, Magenta

Magenta, Italy

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Istituto Clinico Città Studi, Milano

Milan, Italy

Location

Clinica Mediterranea

Napoli, Italy

Location

Ospedale San Salvatore AORMN

Pesaro, Italy

Location

European Hospital

Roma, Italy

Location

Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

Clinical Villa Verde

Taranto, Italy

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

  • Martina Del Maestro

    BIOTRONIK ITALIA SPA

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 19, 2013

First Posted

January 7, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations

IT(18)