NCT01892917

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

13 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

Study Start

First participant enrolled

September 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

4 years

First QC Date

July 2, 2013

Last Update Submit

October 11, 2017

Conditions

Coronary Artery DiseaseMyocardial Ischemia

Keywords

InternationalMulticenterObservational registryOrsiro Drug Eluting Stent (DES)StentingTreatment of Coronary Artery DiseaseCoronary revascularizationPercutaneous Coronary InterventionSTEMINSTEMIIschemiaSubgroupsAcute 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

    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

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 (13)

Állami Szívkórház (State Hospital for cardiology of Balatonfüred)

Balatonfüred, 8231, Hungary

Location

Gottsegen György Országos Kardiológiai Intézet (Gottsegen György Hungarian Institute of Cardiology)

Budapest, 1096, Hungary

Location

Bajcsy-Zsilinszky Kórház (Bajcsy-Zsilinszky Hospital)

Budapest, 1106, Hungary

Location

SE ÁOK Kardiológiai Központ (Semmelweis University, Heart Center)

Budapest, 1122, Hungary

Location

DEOEC, Kardiológiai Intézet ( Institute of Cardiology, University of Debrecen)

Debrecen, 4012, Hungary

Location

Kaposi Mór Oktató Kórház, Kardiológia (Kaposi Mór Teaching Hospital, Cardiology)

Kaposvár, 7400, Hungary

Location

Jósa András Kórház, Kardiológia (Jósa András Hospital, Department of Cardiology)

Nyíregyháza, 4400, Hungary

Location

PTE ÁOK Szívcentrum (University of Pécs, Faculty of Medicine, Heart Institute)

Pécs, 7624, Hungary

Location

Szentgyörgyi Albert Tudomány Egyetem, ÁOK, Kardiológia (University of Szeged, Albert Szent-Györgyi Clinical Center, Faculty Of Medicine, Second Department of Medicine and Cardiology Centre)

Szeged, 6720, Hungary

Location

Fejér Megyei Szent György Kórház (Fejér County Szent György Hospital)

Székesfehérvár, 8001, Hungary

Location

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház, Kardiológia-Hemodinamika (Jász-Nagykun-Szolnok County, Hetényi Géza Hospital, Cardiology, Haemodynamics)

Szolnok, 5004, Hungary

Location

Vas Megyei Markusovszky Kórház Zrt (Vas County, Markusovszky Hospital)

Szombathely, 9400, Hungary

Location

Zala Megyei Kórház, Kardiológia (Zala County Hospital, Cardiology)

Zalaegerszeg, 8900, Hungary

Location

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial IschemiaST Elevation Myocardial InfarctionNon-ST Elevated Myocardial InfarctionIschemiaDiabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

  • Béla Merkely, Prof.

    Semmelweis University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 8, 2013

Study Start

September 1, 2012

Primary Completion

September 1, 2016

Study Completion

December 31, 2016

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations

HU(13)