NCT01895712

Brief Summary

BIOTRONIK - SaFety and Performance Registry for a diabetic patient population with the .bimus Eluting Orsiro Stent System Within daily clinical practice - III

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

6 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

First Submitted

Initial submission to the registry

July 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

1.8 years

First QC Date

July 5, 2013

Last Update Submit

September 26, 2017

Conditions

Coronary Artery DiseaseMyocardial IschemiaDiabetes Mellitus Type 1 or 2

Keywords

InternationalMulticenterObservational registryOrsiro Drug Eluting Stents (DES)StentingTreatment of Coronary Artery DiseaseCoronary revascularizationPercutaneous Coronary Intervention (PCI)Diabetes Mellitus Type 1Diabetes Mellitus Type 2STEMINSTEMIIschemiaAnginaSubgroupsAcute Myocardial InfarctionSmall vesselsChronic Total Occlusion

Outcome Measures

Primary Outcomes (1)

  • Target Vessel Failure (TVF)

    Composite of cardiac death, any target vessel myocardial Infarction, coronary artery bypass graft and clinically driven target vessel revascularization)

    12 months

Secondary Outcomes (6)

  • Target Lesion Failure (TLF)

    12 months

  • Total death

    12 months

  • Cardiac death

    12-month

  • Stent Thrombosis

    12-month

  • Target vessel myocardial infarction

    12-month

  • +1 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

Diabetic subjects (Diabetic patients type 1 or 2) requiring coronary revascularization with Drug Eluting Stents (DES).

You may qualify if:

  • Patients with diabetes mellitus Type 1 or 2
  • Stable coronary patients with moderate-severe symptomatic angina (CCS ≥II) and evidence of myocardial ischemia per non- invasive test (nuclear or echo) or patients with 'silent' myocardial ischemia and a large (e.g. \>10% of myocardium) territory of myocardium in jeopardy (nuclear or echo)
  • Subject signed informed consent
  • 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
  • Left main disease
  • Complex bifurcations
  • Ostial lesions
  • Three vessel disease
  • Large visible thrombus
  • Heavy calcified lesions needing atherectomy or cutting balloon dilatation
  • Syntax Score ≥33
  • Active bleeding
  • Sepsis
  • Chronic total Occlusion
  • Bleeding tendency obviate dual anti platelet (DAP) intake for one year
  • Hb\<11/Plts,100.000/WBC\<4000 or \>11.00
  • Pregnant or nursing subjects and those who plan pregnancy in the period up to 3 years following index procedure. (Female subjects of child- bearing potential must have a negative pregnancy test done within 28 days prior to the index procedure and contraception must be used during participation in this trial)
  • Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel and prasugrel and ticlopidine, inclusive), sirolimus, poly (L-lactide) poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated. Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Rambam medical Center

Haifa, 31096, Israel

Location

Carmel medical Center

Haifa, 34362, Israel

Location

Hadassah medical Center

Jerusalem, 91120, Israel

Location

Meir medical Center

Kfar Saba, 44410, Israel

Location

Rabin Medical Center

Petah Tikva, 49104, Israel

Location

Sheba medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial IschemiaDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2ST Elevation Myocardial InfarctionNon-ST Elevated Myocardial InfarctionIschemiaAngina Pectoris

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesMyocardial InfarctionInfarctionPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Ran Kornowski, Prof

    Rabin Medical Center

    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 5, 2013

First Posted

July 10, 2013

Study Start

August 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 28, 2017

Record last verified: 2017-09

Locations

IL(6)