Coronary Artery DiseaseBIOSSNCT03475563
BiOSS Study (BiOSS LIM C Stent Registry in Bifurcated Lesions)
An observational study of Coronary Artery Disease, run by Hospital Universitari Vall d'Hebron Research Institute at 3 sites in Spain.
Trial summary
The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . The objective of the study is providing deeper knowledge into the results of this stent in the treatment of bifurcational lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary angioplasty with stent implantation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 3 sitesSpain
- Study dates
- 16 Aug 2018to 30 Dec 2019
- 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: Patients with ischemic heart disease referred for coronary revascularization will be included with susceptible lesion of coronary intervention in bifurcation.
Who may be able to join
- Age over 18 years.
- Clinical indication of coronary angioplasty in bifurcated lesion.
- Bifurcated lesions with both distal branches at least 2 mm in diameter.
- The lesion must be located in the main branch, with a severe stenosis by visual estimation at some point in the main branch, with or without involvement of the lateral branch.
- Express acceptance and signature of informed consent.
Who cannot join
- Express rejection of the patient to participate in the study.
- Exclusive involvement of the lateral branch (Medina lesion 001).
- Contraindication for antiplatelet treatment.
- Lesions due to restenosis.
- Lesions in saphenous grafts.
- Total chronic occlusions.
- Cardiogenic shock.
Trial locations and contacts
3 sites in 1 country.
Imanol Otaegui contact
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Imanol Otaegui, MD
- Recruiting
Hospital Universitario de León
León, 24071
Armando Pérez de Prado, MD, PhD
- Recruiting
Hospital Universitari Parc Taulí
Sabadell, Barcelona, 08208
Eduard Bosch, MD
About this study
Official title: BiOSS LIM C Stent Registry in Bifurcated Lesions
The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . The objective of the study is providing deeper knowledge into the results of this stent in the treatment of bifurcational lesions.
Read the detailed description
The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . The objective of the study is providing deeper knowledge into the results of this stent in the treatment of bifurcational lesions.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary angioplasty with stent implantation
- Keywords
- Drug-eluting stent, Dedicated bifurcation stent, Cobalt-chromium, Sirolimus-eluting stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angioplasty with stent implantationProcedure or surgery
Coronary angioplasty with BiOSS LIM C stent implantation
| Study group | Role | What they receive |
|---|---|---|
| Patients with coronary artery disease | (coronary artery disease) Receives: Procedure: Coronary angioplasty with stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful angioplasty
After angiography: TIMI (thrombolysis in myocardial infarction ) 3 (both branches). With respect to reference diameter, none of the segments treated with stent has a residual stenosis> 30% or> 50% in those not treated with stent.
Measured: 1 day
MACE
Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) and repeated revascularization of the target lesion (TLR)
Measured: 30 days
MACE
Cumulative rate of major adverse cardiovascular events (MACE) including cardiac
Measured: 1 year
Secondary outcomes (4)
Target vessel revascularization
Target vessel revascularization
Measured: 30 days
Percentage of stent struts malposition
Percentage of stent struts malposition
Measured: 30 days
contrast media volume
contrast media volume
Measured: 1 day
Angioplasty time
Angioplasty time
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start16 Aug 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imanol Otaegui, MD, Principal investigator, Hospital Universitari Vall d'hebron Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475563
- Sponsor's protocol ID
- BIOSS
- Acronym
- BIOSS
- Status last verified
- Nov 2019
- First submitted
- 16 Mar 2018
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Gil RJ, Bil J, Dzavik V, Vassilev D, Kern A, Formuszewicz R, Zalewska-Adamiec M, Dobrzycki S. Regular Drug-Eluting Stent vs Dedicated Coronary Bifurcation BiOSS Expert Stent: Multicenter Open-Label Randomized Controlled POLBOS I Trial. Can J Cardiol. 2015 May;31(5):671-8. doi: 10.1016/j.cjca.2014.12.024. Epub 2014 Dec 24.
PubMed 25828372Gil RJ, Bil J, Vassiliev D, Inigo Garcia LA. First-in-man study of dedicated bifurcation sirolimus-eluting stent: 12-month results of BiOSS LIM(R) Registry. J Interv Cardiol. 2015 Feb;28(1):51-60. doi: 10.1111/joic.12180.
PubMed 25689548Gil RJ, Bil J, Grundeken MJ, Inigo Garcia LA, Vassilev D, Kern A, Pawlowski T, Wykrzykowska JJ, Serruys PW. Long-term effectiveness and safety of the sirolimus-eluting BiOSS LIM(R) dedicated bifurcation stent in the treatment of distal left main stenosis: an international registry. EuroIntervention. 2016 Nov 20;12(10):1246-1254. doi: 10.4244/EIJY15M10_05.
PubMed 26465375
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BiOSS LIM C Stent Registry in Bifurcated Lesions
- ClinicalTrials.gov ID
- NCT03475563
- Acronym / sponsor ID
- BIOSS / BIOSS
- Conditions
- Coronary Artery Disease
- Keywords
- Drug-eluting stent, Dedicated bifurcation stent, Cobalt-chromium, Sirolimus-eluting stent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 23 Mar 2018 (actual)
- 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.
The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . The objective of the study is providing deeper knowledge into the results of this stent in the treatment of bifurcational lesions.
Detailed description
The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . The objective of the study is providing deeper knowledge into the results of this stent in the treatment of bifurcational lesions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with coronary artery disease | – | Procedure: Coronary angioplasty with stent implantation(coronary artery disease) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic heart disease referred for coronary revascularization will be included with susceptible lesion of coronary intervention in bifurcation.
Key inclusion criteria (5 listed)
- Age over 18 years.
- Clinical indication of coronary angioplasty in bifurcated lesion.
- Bifurcated lesions with both distal branches at least 2 mm in diameter.
- The lesion must be located in the main branch, with a severe stenosis by visual estimation at some point in the main branch, with or without involvement of the lateral branch.
- Express acceptance and signature of informed consent.
Key exclusion criteria (7 listed)
- Express rejection of the patient to participate in the study.
- Exclusive involvement of the lateral branch (Medina lesion 001).
- Contraindication for antiplatelet treatment.
- Lesions due to restenosis.
- Lesions in saphenous grafts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary angioplasty with stent implantationCoronary angioplasty with BiOSS LIM C stent implantation | Procedure or surgery | Patients with coronary artery disease |
Primary outcome
Successful angioplasty
Time frame: 1 day
After angiography: TIMI (thrombolysis in myocardial infarction ) 3 (both branches). With respect to reference diameter, none of the segments treated with stent has a residual stenosis> 30% or> 50% in those not treated with stent.
MACE
Time frame: 30 days
Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) and repeated revascularization of the target lesion (TLR)
MACE
Time frame: 1 year
Cumulative rate of major adverse cardiovascular events (MACE) including cardiac
4 secondary outcomes
Target vessel revascularization
Time frame: 30 days
Percentage of stent struts malposition
Time frame: 30 days
contrast media volume
Time frame: 1 day
Angioplasty time
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Results publication: PubMed 25828372Gil RJ, Bil J, Dzavik V, Vassilev D, Kern A, Formuszewicz R, Zalewska-Adamiec M, Dobrzycki S. Regular Drug-Eluting Stent vs Dedicated Coronary Bifurcation BiOSS Expert Stent: Multicenter Open-Label Randomized Controlled POLBOS I Trial. Can J Cardiol. 2015 May;31(5):671-8. doi: 10.1016/j.cjca.2014.12.024. Epub 2014 Dec 24.
- Results publication: PubMed 25689548Gil RJ, Bil J, Vassiliev D, Inigo Garcia LA. First-in-man study of dedicated bifurcation sirolimus-eluting stent: 12-month results of BiOSS LIM(R) Registry. J Interv Cardiol. 2015 Feb;28(1):51-60. doi: 10.1111/joic.12180.
- Results publication: PubMed 26465375Gil RJ, Bil J, Grundeken MJ, Inigo Garcia LA, Vassilev D, Kern A, Pawlowski T, Wykrzykowska JJ, Serruys PW. Long-term effectiveness and safety of the sirolimus-eluting BiOSS LIM(R) dedicated bifurcation stent in the treatment of distal left main stenosis: an international registry. EuroIntervention. 2016 Nov 20;12(10):1246-1254. doi: 10.4244/EIJY15M10_05.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Imanol Otaegui contact
Imanol Otaegui, MD principal investigator
Hospital Universitari Vall d'hebron Barcelona, Spain
3 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 Hospital Universitari Vall d'Hebron Research Institute at 3 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imanol Otaegui, MD (+342746155, iotaegui@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful angioplasty (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03475563, which also lists 3 linked publications.
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 27 Nov 2019.