NCT02247492

Brief Summary

Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the patient's body inflammation status correlates with the clinical outcome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
unknown

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

September 17, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
2.6 years until next milestone

Study Start

First participant enrolled

April 14, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

September 17, 2014

Last Update Submit

July 19, 2018

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 (7)

  • Target Lesion Failure (TLF)

    6 and 36 months

  • Target Vessel Revascularization (TVR)

    6 and 36 months

  • Target Lesion Revascularization (TLR)

    6 and 36 months

  • Stent Thrombosis

    6, 12 and 36 months

  • Clinical Device Success

    participants will be followed for the duration of hospital stay, an expected average of 1 day

  • +2 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 (7)

Research Institute for Complex Problems of Cardiovascular Diseases

Kemerovo, Russia

RECRUITING

Regional Clinical Hospital

Nizhny Novgorod, Russia

RECRUITING

Novosibirsk Scientific Research Institute of Circulation Pathology

Novosibirsk, Russia

RECRUITING

City Emergency Clinical Hospital of Rostov-on-Don

Rostov-on-Don, Russia

RECRUITING

North-West Federal Medical Research Center named after V.A. Almazov

Saint Petersburg, Russia

RECRUITING

Institute of Cardiology, Tomsk Medical Research

Tomsk, Russia

RECRUITING

Ural Institute of Cardiology

Yekaterinburg, Russia

RECRUITING

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

  • Evgeny Kretov, Dr.

    Novosibirsk Research Institute for Circulation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ildar Khassanov, Dr.

CONTACT

+49 9131 852 56 34ildar.khassanov@biotronik.com

Study Design

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

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 25, 2014

Study Start

April 14, 2017

Primary Completion

April 1, 2019

Study Completion

May 1, 2021

Last Updated

July 23, 2018

Record last verified: 2018-07

Locations

RU(7)