NCT01831336

Brief Summary

This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
332

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
1 country

8 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

Study Start

First participant enrolled

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

3.3 years

First QC Date

April 11, 2013

Last Update Submit

September 26, 2017

Conditions

Coronary Artery DiseaseMyocardial Ischemia

Keywords

InternationalMulticenterObservational registryOrsiro Drug Eluting Stent (DES)StentingTreatment of Coronary Artery DiseaseCoronary revascularizationPercutaneous Coronary InterventionSTEMINSTEMIIschemiaAnginaSubgroupsAcute Myocardial InfarctionDiabetesSmall 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), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)

    12 months

Secondary Outcomes (6)

  • Target Vessel Revascularization (TVR)

    6 and 12 months

  • Target Lesion Revascularization (TLR)

    6 and 12 months

  • Stent Thrombosis

    6 and 12 months

  • Clinical Device Success

    At time of intervention

  • Clinical Procedural Success

    During the hospital stay to a maximum of the first seven days post index procedure

  • +1 more secondary outcomes

Study Arms (1)

Orsiro DES

Eligibility Criteria

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

All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (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

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 of PCI unless dual antiplatelet therapy will be maintained
  • Currently participating in another study and primary endpoint is not reached yet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

UCL St. Luc

Brussels, 1200, Belgium

Location

Brussels Heart Center

Brussels, Belgium

Location

CHU Charleroi

Charleroi, Belgium

Location

Grand Hopital de Charleroi Saint Joseph

Gilly, Belgium

Location

CHR de la Citadelle

Liège, Belgium

Location

CHU Liège

Liège, Belgium

Location

Brussels Heart Center St Pierre

Ottignies, Belgium

Location

UCL de Mont Godine

Yvoir, Belgium

Location

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial IschemiaST Elevation Myocardial InfarctionNon-ST Elevated Myocardial InfarctionIschemiaAngina PectorisDiabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMyocardial InfarctionInfarctionPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisChest PainPainNeurologic ManifestationsSigns and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Victor Legrand, Prof. Dr.

    CHU Liege (Hospitalo-Facultaire Universitaire de Liège)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2013

First Posted

April 15, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 28, 2017

Record last verified: 2017-09

Locations

BE(8)