Coronary Artery DiseaseNCT02029092
BIOFLOW III Satellite-ELADIS Orsiro Stent System
An observational study of Coronary Artery Disease, run by C.E.M. Biotronik, S.A. at 14 sites in Spain.
Trial summary
This registry is a clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 404 participants
- Where
- 14 sitesSpain
- Study dates
- Feb 2014to Jul 2016
- How long will I take part?
- 12 Months
- 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: All subjects requiring coronary revascularization with Drug Eluting Stents (DES)
Who may be able to join
- Symptomatic coronary artery disease
- Subject has signed informed consent for data release
- 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 for data release
- Pregnancy
- Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation, antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media.
- Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
- Currently participating in another study and primary endpoint is not yet reached.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Hospital Infanta Cristina
Badajoz
Hospital Vall D' Hebron
Barcelona
Hospital G.de Jerez de la Frontera
Cadiz
Hospital Universitario León
León, A/Altos de Nava S/n, 24080
Hospital de Mérida
Mérida
Hospital Univ. Virgen de la Arrixaca
Murcia
Hospital Parc Tauli
Sabadell
Complejo de Hospitalario de Santiago
Santiago de Compostela, 15702
Hospital Virgen del Rocio
Seville
Hospital Mutua de Terrassa
Terrassa
Hospital Clinico de Valencia
Valencia
Hospital Doctor Peset
Valencia
Hospital de Txagorritxu
Vitoria-Gasteiz
Hospital de Cruces
Vizcaya, 48903
About this study
Official title: BIOTRONIK- Safety and Performance Registry for an All Comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice III- ELADIS
This registry is a clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.
Read the detailed description
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil 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 to 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 to 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 neontimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in 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.
Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. Results will contribute to the collection of clinical evidence for the clinical performance and safety of ORSIRO drug eluting stent system in daily clinical practice.
- Conditions
- Coronary Artery Disease
- Keywords
- International, Multicenter, Observational registry, Orsiro Drug Eluting Stent (DES), Stenting, Treatment of coronary artery disease, Coronary revascularization, Percutaneous Coronary Intervention (PCI), STEMI, NSTEMI, Ischemia, Angina, Acute Myocardial Infarction (AMI), Small Vessels, Chronical Total Occlusion (CTO)
- Medical subject headings
- Coronary Artery Disease, 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 Lesion Failure (TLF)
Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR).
Measured: 12 months
Secondary outcomes (6)
TLF
Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR).
Measured: 6 months
Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR)
Measured: 6 and 12 months
Target lesion revascularization (TLR)
Target lesion revascularization (TLR)
Measured: 6 and 12 months
Stent Thrombosis rate
Stent Thrombosis rate
Measured: 6 and 12 months
Device success
Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation, without using any adjunctive device outside the assigned treatment strategy
Measured: up to discharge
Procedure success
Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation, without using any adjunctive device and without the occurrence of ischemia-driven major cardiac event during the hospital stay to a maximum of the first seven days post index procedure.
Measured: up to 7 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2016
- Study completionJul 2016
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
- 404 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- C.E.M. Biotronik, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sonia Martin, Study director, CEM BIOTRONIK SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029092
- Sponsor's protocol ID
- G1302
- Status last verified
- Sep 2017
- First submitted
- 19 Dec 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
- BIOTRONIK- Safety and Performance Registry for an All Comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice III- ELADIS
- ClinicalTrials.gov ID
- NCT02029092
- Acronym / sponsor ID
- G1302
- Conditions
- Coronary Artery Disease
- Keywords
- International, Multicenter, Observational registry, Orsiro Drug Eluting Stent (DES), Stenting, Treatment of coronary artery disease, Coronary revascularization, Percutaneous Coronary Intervention (PCI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- C.E.M. Biotronik, S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Jan 2014 (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.
This registry is a clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.
Detailed description
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil 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 to 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 to 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 neontimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in 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.
Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. Results will contribute to the collection of clinical evidence for the clinical performance and safety of ORSIRO drug eluting stent system in daily clinical practice.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- 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
- All subjects requiring coronary revascularization with Drug Eluting Stents (DES)
Key inclusion criteria (4 listed)
- Symptomatic coronary artery disease
- Subject has signed informed consent for data release
- Subject is geographically stable and willing to participate at all follow up assessments
- Subject is≥18 years of age.
Key exclusion criteria (5 listed)
- Subject did not sign informed consent for data release
- Pregnancy
- Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation, antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media.
- Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
- Currently participating in another study and primary endpoint is not yet reached.
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 Lesion Failure (TLF)
Time frame: 12 months
Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR).
6 secondary outcomes
TLF
Time frame: 6 months
Target Vessel Revascularization (TVR)
Time frame: 6 and 12 months
Target lesion revascularization (TLR)
Time frame: 6 and 12 months
Stent Thrombosis rate
Time frame: 6 and 12 months
Device success
Time frame: up to discharge
Procedure success
Time frame: up to 7 days after procedure
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.
Sonia Martin study director
CEM BIOTRONIK SA
14 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, run by C.E.M. Biotronik, S.A. at 14 sites in Spain.
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 4 inclusion and 5 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 14 sites in Spain. 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 Lesion Failure (TLF) (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.