NCT01593059

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

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

4 active sites

Status
terminated

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

May 4, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

April 28, 2014

Status Verified

August 1, 2012

Enrollment Period

1.2 years

First QC Date

May 4, 2012

Last Update Submit

April 25, 2014

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 Lesion Failure (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

    At time of intervention

  • +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
  • Elective PCI with DES

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 (4)

Cardiovascular Diseases Institute CC Iliescu

Bucharest, Romania

Location

University Hospital Bucharest

Bucharest, Romania

Location

County Emergency Hospital

Cluj-Napoca, Romania

Location

Country Hospital

Târgu Mureş, 540136, Romania

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

  • Dragos Vinereanu, Prof.

    University Hospital Bucharest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2012

First Posted

May 7, 2012

Study Start

August 1, 2012

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

April 28, 2014

Record last verified: 2012-08

Locations

RO(4)