NCT02257710

Brief Summary

Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

4 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

October 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

3.1 years

First QC Date

October 2, 2014

Last Update Submit

September 28, 2017

Conditions

Coronary Artery Diseases

Keywords

nationalMulticenterObservational registryOrsiro Drug Eluting Stent (DES)StentingTreatment of coronary artery diseaseCoronary revascularizationCoronary InterventionSTEMINSTEMIIschemiaAnginaAcute Myocardial Infarction (AMI)Small VesselsChronic Total Occlusion

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 (6)

  • TLF

    6 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

    up to seven days

  • +1 more secondary outcomes

Study Arms (1)

Orsiro

All subjects requiring coronary revascularization with Drug Eluting Stents (DES)

Device: Orsiro

Interventions

OrsiroDEVICE
Orsiro

Eligibility Criteria

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

subjects from an 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 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 for data release
  • 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 (4)

Royal Sussex County Hospital

Brighton, East-Sussex, BN2 5BE, United Kingdom

RECRUITING

St Peter's Hospital

Chertsey, Surrey, KT16 0PZ, United Kingdom

RECRUITING

University Hospital Southampton

Southampton, United Kingdom

RECRUITING

Royal Cornwall Hospital

Truro, United Kingdom

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

  • Michael Mahmoudi, MD

    St. Peter's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcus Knott

CONTACT

+44 (0) 7970084632marcus.knott@biotronik.com

Study Design

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

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 6, 2014

Study Start

November 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations

GB(4)