Coronary Artery DiseaseNCT01895712
BIOFLOW-III Israel Satellite Registry
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by BIOTRONIK Israel at 6 sites in Israel.
Trial summary
BIOTRONIK - SaFety and Performance Registry for a diabetic patient population with the .bimus Eluting Orsiro Stent System Within daily clinical practice - III Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia, Diabetes Mellitus Type 1 or 2
- How many people
- 120 participants
- Where
- 6 sitesIsrael
- Study dates
- Aug 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic subjects (Diabetic patients type 1 or 2) requiring coronary revascularization with Drug Eluting Stents (DES).
Who may be able to join
- 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
Who cannot join
- Subject did not sign informed consent
- Left main disease
- Complex bifurcations
- Ostial lesions
- Three vessel disease
- Large visible thrombus
Show all 17Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Israel6 sites
Rambam medical Center
Haifa, 31096
Carmel medical Center
Haifa, 34362
Hadassah medical Center
Jerusalem, 91120
Meir medical Center
Kfar Saba, 44410
Rabin Medical Center
Petah Tikva, 49104
Sheba medical Center
Tel HaShomer, 52621
About this study
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
BIOTRONIK - SaFety and Performance Registry for a diabetic patient population with the .bimus Eluting Orsiro Stent System Within daily clinical practice - III
Read the 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.
- 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
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Ischemia, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Orsiro | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Vessel Failure (TVF)
Composite of cardiac death, any target vessel myocardial Infarction, coronary artery bypass graft and clinically driven target vessel revascularization)
Measured: 12 months
Secondary outcomes (6)
Target Lesion Failure (TLF)
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)
Measured: 12 months
Total death
Total death
Measured: 12 months
Cardiac death
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.
Measured: 12-month
Stent Thrombosis
Definite/probable-ARC define
Measured: 12-month
Target vessel myocardial infarction
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.
Measured: 12-month
Target lesion revascularization (TLR)
Defined as any repeat revascularization of the target lesion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- BIOTRONIK Israel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ran Kornowski, Prof, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895712
- Sponsor's protocol ID
- G1227
- Status last verified
- Sep 2017
- First submitted
- 5 Jul 2013
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01895712
- Acronym / sponsor ID
- G1227
- Keywords
- International, Multicenter, Observational registry, Orsiro Drug Eluting Stents (DES), Stenting, Treatment of Coronary Artery Disease, Coronary revascularization, Percutaneous Coronary Intervention (PCI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- BIOTRONIK IsraelIndustry (pharma, biotech, devices)
- Study start
- Aug 2013 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orsiro | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic subjects (Diabetic patients type 1 or 2) requiring coronary revascularization with Drug Eluting Stents (DES).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- Subject did not sign informed consent
- Left main disease
- Complex bifurcations
- Ostial lesions
- Three vessel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
6 secondary outcomes
Target Lesion Failure (TLF)
Time frame: 12 months
Total death
Time frame: 12 months
Cardiac death
Time frame: 12-month
Stent Thrombosis
Time frame: 12-month
Target vessel myocardial infarction
Time frame: 12-month
Target lesion revascularization (TLR)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ran Kornowski, Prof principal investigator
Rabin Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by BIOTRONIK Israel at 6 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Vessel Failure (TVF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.