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


Lead Sponsor: BIOTRONIK Israel

Source BIOTRONIK Israel
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.

Overall Status Completed
Start Date August 2013
Completion Date June 2015
Primary Completion Date June 2015
Study Type Observational
Primary Outcome
Measure Time Frame
Target Vessel Failure (TVF) 12 months
Secondary Outcome
Measure Time Frame
Target Lesion Failure (TLF) 12 months
Total death 12 months
Cardiac death 12-month
Stent Thrombosis 12-month
Target vessel myocardial infarction 12-month
Target lesion revascularization (TLR) 12 months
Enrollment 120

Sampling Method: Non-Probability Sample


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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ran Kornowski, Prof Principal Investigator Rabin Medical Center
Rambam medical Center | Haifa, 31096, Israel
Carmel medical Center | Haifa, 34362, Israel
Hadassah medical Center | Jerusalem, 91120, Israel
Meir medical Center | Kfar Saba, 44410, Israel
Rabin Medical Center | Petah Tikva, 49104, Israel
Sheba medical Center | Tel Hashomer, 52621, Israel
Location Countries


Verification Date

September 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Orsiro

Study Design Info

Observational Model: Other

Time Perspective: Prospective