BIOFLOW-III Israel Satellite Registry

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


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

Study Type: Observational
Study Design: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ 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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895712

Contacts
Contact: Shlomit Brandis +972547790828 Shlomit.brandis@biotronik.com

Locations
Israel
Carmel medical Center Recruiting
Haifa, Israel, 34362
Contact: Amnon Merdler, Dr         
Principal Investigator: Amnon Merdler, Dr         
Rambam medical Center Recruiting
Haifa, Israel, 31096
Contact: Ariel Roguin, Prof         
Principal Investigator: Ariel Roguin, Prof         
Hadassah medical Center Recruiting
Jerusalem, Israel, 91120
Contact: Haim Danenberg, Prof         
Principal Investigator: Haim Danenberg, Prof         
Meir medical Center Recruiting
Kfar sava, Israel, 44410
Contact: Eliezer Rozenbaum, Dr         
Principal Investigator: Eliezer Rosenbaum, Dr         
Rabin Medical Center Recruiting
Petah Tikva, Israel, 49104
Contact: Kornowski Ran, Prof         
Principal Investigator: Ran Kornowski, Prof         
Sheba medical Center Recruiting
Tel Hashomer, Israel, 52621
Contact: Victor Guetta, Prof         
Principal Investigator: Victor Guetta, Prof         
Sponsors and Collaborators
BIOTRONIK Israel
Investigators
Principal Investigator: Ran Kornowski, Prof Rabin Medical Center
  More Information

No publications provided

Responsible Party: BIOTRONIK Israel
ClinicalTrials.gov Identifier: NCT01895712     History of Changes
Other Study ID Numbers: G1227
Study First Received: July 5, 2013
Last Updated: April 8, 2014
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014