BIOFLOW-III Israel Satellite Registry

This study is currently recruiting participants.
Verified July 2013 by BIOTRONIK Israel
Sponsor:
Information provided by (Responsible Party):
BIOTRONIK Israel
ClinicalTrials.gov Identifier:
NCT01895712
First received: July 5, 2013
Last updated: April 8, 2014
Last verified: July 2013

July 5, 2013
April 8, 2014
August 2013
February 2015   (final data collection date for primary outcome measure)
Target Vessel Failure (TVF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Composite of cardiac death, any target vessel myocardial Infarction, coronary artery bypass graft and clinically driven target vessel revascularization)
Same as current
Complete list of historical versions of study NCT01895712 on ClinicalTrials.gov Archive Site
  • Target Lesion Failure (TLF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
    Definite/probable-ARC define
  • Target vessel myocardial infarction [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization (TVR) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
BIOFLOW-III Israel Satellite Registry
Safety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III Canada

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Coronary Artery Disease
  • Myocardial Ischemia
  • Diabetes Mellitus Type 1 or 2
Not Provided
Orsiro
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
April 2015
February 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Shlomit Brandis +972547790828 Shlomit.brandis@biotronik.com
Israel
 
NCT01895712
G1227
No
BIOTRONIK Israel
BIOTRONIK Israel
Not Provided
Principal Investigator: Ran Kornowski, Prof Rabin Medical Center
BIOTRONIK Israel
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP