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BIOFLOW-III Israel Satellite Registry

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01895712
First Posted: July 10, 2013
Last Update Posted: September 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
BIOTRONIK Israel
  Purpose
BIOTRONIK - SaFety and Performance Registry for a diabetic patient population with the .bimus Eluting Orsiro Stent System Within daily clinical practice - III

Condition
Coronary Artery Disease Myocardial Ischemia Diabetes Mellitus Type 1 or 2

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Safety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III Canada

Resource links provided by NLM:


Further study details as provided by BIOTRONIK Israel:

Primary Outcome Measures:
  • Target Vessel Failure (TVF) [ Time Frame: 12 months ]
    Composite of cardiac death, any target vessel myocardial Infarction, coronary artery bypass graft and clinically driven target vessel revascularization)


Secondary Outcome Measures:
  • Target Lesion Failure (TLF) [ Time Frame: 12 months ]
    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)

  • Total death [ Time Frame: 12 months ]
    Total death

  • Cardiac death [ Time Frame: 12-month ]
    Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death I death of unknown cause and all procedurerelated deaths, including those related to concomitant treatment.

  • Stent Thrombosis [ Time Frame: 12-month ]
    Definite/probable-ARC define

  • Target vessel myocardial infarction [ Time Frame: 12-month ]

    Myocardial infarction will be adjudicated according to the Joint ESC/ACCF/AHA/WHF Task Force universal definition of myocardial infarction12

    • 14and on the basis of the 2010 ARC extended historical definition of myocardial infarction.


  • Target lesion revascularization (TLR) [ Time Frame: 12 months ]
    Defined as any repeat revascularization of the target lesion


Enrollment: 120
Actual Study Start Date: August 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Detailed Description:

For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30%-50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures. The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.

An interesting group of analysis resulted to be diabetic patients. It has been concluded that the incidence of both nonocclusive and occlusive restenosis is higher in diabetic subjects after stenting as judged from comparison with historical control subjects. Results implicate accelerated restenosis as both a consequence of diabetes and a cause for increased mortality after PCI in diabetic patient.

Therefore this observational registry has been designed for the clinical evaluation of the Orsiro LESS in diabetic subjects (Diabetic patients type 1 or 2) requiring coronary revascularization with Drug Eluting Stents (DES). Results will contribute to the collection of clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in daily clinical practice.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diabetic subjects (Diabetic patients type 1 or 2) requiring coronary revascularization with Drug Eluting Stents (DES).
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Currently participating in another study and primary endpoint is not reached yet.
  • Other medical illness (e.g, cancer or congestive heart failure) or Known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895712


Locations
Israel
Rambam medical Center
Haifa, Israel, 31096
Carmel medical Center
Haifa, Israel, 34362
Hadassah medical Center
Jerusalem, Israel, 91120
Meir medical Center
Kfar Saba, Israel, 44410
Rabin Medical Center
Petah Tikva, Israel, 49104
Sheba medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
BIOTRONIK Israel
Investigators
Principal Investigator: Ran Kornowski, Prof Rabin Medical Center
  More Information

Responsible Party: BIOTRONIK Israel
ClinicalTrials.gov Identifier: NCT01895712     History of Changes
Other Study ID Numbers: G1227
First Submitted: July 5, 2013
First Posted: July 10, 2013
Last Update Posted: September 28, 2017
Last Verified: September 2017

Keywords provided by BIOTRONIK Israel:
International
Multicenter
Observational registry
Orsiro Drug Eluting Stents (DES)
Stenting
Treatment of Coronary Artery Disease
Coronary revascularization
Percutaneous Coronary Intervention (PCI)
Diabetes Mellitus Type 1
Diabetes Mellitus Type 2
STEMI
NSTEMI
Ischemia
Angina
Subgroups
Acute Myocardial Infarction
Small vessels
Chronic Total Occlusion

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Autoimmune Diseases
Immune System Diseases