NCT01667003

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
406

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

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

August 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

2.3 years

First QC Date

August 15, 2012

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 Vessels

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 12 months

  • 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

  • +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)

Falun Lasarett

Falun, Sweden

Location

Halmstad Hospital

Halmstad, Sweden

Location

Helsingborg Hospital

Helsingborg, Sweden

Location

Centralsjukhuset i Karlstad

Karlstad, Sweden

Location

Kardiologiska Kliniken

Örebro, 701 85, Sweden

Location

Hjärtmottagningen

Stockholm, 11883, Sweden

Location

Danderyd University Hospital

Stockholm, Sweden

Location

Karolinska University Hospitals (Huddinge/Solna)

Stockholm, Sweden

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

  • Ole Froebert, MD

    Kardiologiska Kliniken

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 15, 2012

First Posted

August 17, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

September 28, 2017

Record last verified: 2017-09

Locations

SE(8)