Clinical trial NCT01895712: BIOFLOW-III Israel Satellite Registry
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Myocardial Ischemia
Diabetes Mellitus Type 1 or 2
Keywords: 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
Lead sponsor: BIOTRONIK Israel
Sponsor class: INDUSTRY
First posted: 2013-07-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic subjects (Diabetic patients type 1 or 2) requiring coronary revascularization with Drug Eluting Stents (DES).

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

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 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.

Primary outcomes:
measure: Target Vessel Failure (TVF)
timeFrame: 12 months
Secondary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
measure: Total death
timeFrame: 12 months
measure: Cardiac death
timeFrame: 12-month
measure: Stent Thrombosis
timeFrame: 12-month
measure: Target vessel myocardial infarction
timeFrame: 12-month
measure: Target lesion revascularization (TLR)
timeFrame: 12 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam medical Center
city: Haifa
country: Israel
facility: Carmel medical Center
city: Jerusalem
country: Israel
facility: Hadassah medical Center
city: Kfar Saba
country: Israel
facility: Meir medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba medical Center
Study officials:
affiliation: Rabin Medical Center
name: Ran Kornowski, Prof
role: PRINCIPAL_INVESTIGATOR
References: