Coronary Artery DiseaseOraBilNCT06736899
Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
A study testing Orbital Atherectomy System Treatment and Balloon System Treatment in people with Coronary Artery Disease and Coronary Disease, run by Fundación EPIC at 9 sites in Spain.
Trial summary
Clinical research with medical devices indicated in accordance with the CE marking, led by researchers, multicenter, open, prospective, randomized and controlled. Patients are randomized to treatment with a conventional balloon and then a coronary stent or to initial plaque modification with Orbital Atherectomy (OA)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Disease
- What is being tested?
- Orbital Atherectomy System Treatment and Balloon System Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 9 sitesSpain
- Study dates
- 23 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients over 18 years of age and
- Patients with moderately or severely calcified bifurcation lesions (lateral vessel ≥ 2mm), candidates for PCI with coronary stent implantation, in whom there is the possibility of adequate clinical follow-up at 1 year and
- Patients agree to participate in the study, by signing the Informed Consent.
Who cannot join
- Patients with revascularization of the artery to be treated within 9 months prior to the index procedure.
- Patients with contraindication for the use of Orbital Atherectomy:
- Patients in cardiogenic shock.
- Patients with Thrombotic lesions.
- Patients with Vascular graft disease.
- Patients with remain vessel disease.
Show all 9Show fewer
- Patients with severe left ventricular dysfunction.
- Patients allergic to the components of the washing serum (glide).
- Patients with life expectancy less than one year.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Spain9 sites, 9 recruiting
- Recruiting
H. G.U. de ALICANTE DR. BALMIS
Alicante, 03010
- Recruiting
Hospital Del Mar
Barcelona, 08003
- Recruiting
H. de La Santa Creu I Sant Pau
Barcelona, 08041
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
- Recruiting
Hospital Universitario La Paz
Fuencarral-El Pardo, 28046
- Recruiting
Hospital Universitario Lucus Augusti
Lugo, 270003
- Recruiting
Hospital Universitario La Luz
Madrid, 28003
- Recruiting
Hospital Universitari de Salamanca
Salamanca, 37007
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
About this study
Official title: Randomized Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
Clinical research with medical devices indicated in accordance with the CE marking, led by researchers, multicenter, open, prospective, randomized and controlled. Patients are randomized to treatment with a conventional balloon and then a coronary stent or to initial plaque modification with Orbital Atherectomy (OA) and then a coronary stent. To evaluate the efficacy and safety of OA in the adequate treatment with coronary stent of the calcified bifurcation lesion using angiography and optical coherence tomography (OCT).
Read the detailed description
The risk profile of patients and their comorbidities have worsened and the observed lesions undergoing treatment are increasingly complex. This has promoted the development of new technologies for plaque modification, especially in the context of calcified lesions. These predispose to suboptimal results of the intervention due to an increased risk of malapposition and underexpansion of the stents, the main variables for restenosis and/or thrombosis of the stents. Thus, compared with non-calcified lesions, the increased amount of calcium in the coronary artery leads to a higher incidence of major adverse cardiac events (MACE).
Coronary bifurcation stenting remains complex and is associated with a high risk of stent thrombosis and restenosis even with contemporary techniques, and suboptimal outcomes are frequently observed due to side branch (SL) involvement that increases cardiovascular events.
Our hypothesis is that the use of orbital atherectomy (OA) for coronary revascularization in the presence of calcified bifurcation lesions is feasible and safe compared to the more common technique, favoring the subsequent performance of provisional stenting (PS).
- Conditions
- Coronary Artery Disease, Coronary Disease
- Being tested
- Orbital Atherectomy System Treatment, Balloon System Treatment
- Keywords
- Orbital Atherectomy (OA), Percutaneous Coronary Intervention, Bifurcation, Side Branch Treatment: Mid-term results
- Medical subject headings
- Coronary Artery Disease, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orbital Atherectomy System TreatmentDevice
Percutaneous coronary intervention of a calcified bifurcation coronary lesion with balloon angioplasty followed by drug eluting stent. Selection of balloon type is at operator´s discretion. Baseline and post dilation OCT will be performed.
Balloon System TreatmentDevice
Percutaneous coronary intervention of a calcified bifurcation coronary lesion with Orbital Atherectomy followed by drug eluting stent. Baseline and post dilation OCT will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Balloon Angioplasty (BA) | Active comparator | Not described Receives: Device: Balloon System Treatment |
| Orbital Atherectomy (OA) | Active comparator | Not described Receives: Device: Orbital Atherectomy System Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFICACY: Angiographic criteria success
Percentage of Main vessel and side branch (≥2 mm) patency (final stenosis <20%) without the presence of: residual lesion >70% and TIMI flow < 3 and residual ≥ type C disection
Measured: At the end of PCI (Percutaneous Coronary Intervention)
EFFICACY: OCT criteria: Stent expansion
Percentage of MLA / mean reference luminal area (mean proximal and distal reference luminal)
Measured: At the end of PCI
Secondary outcomes (8)
SAFETY:Major adverse cardiac events (MACE)
Rate of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and non-target lesion target vessel revascularization (TVR non-TLR), thrombosis and stroke
Measured: 12 months
SAFETY:Major adverse cardiac events (MACE)
Rate of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and non-target lesion target vessel revascularization (TVR non-TLR), thrombosis and stroke
Measured: 6 months
SAFETY:Major adverse cardiac events (MACE)
Rate of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and non-target lesion target vessel revascularization (TVR non-TLR), thrombosis and stroke
Measured: 30 days
SAFETY:Major adverse cardiac events (MACE)
Rate of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and non-target lesion target vessel revascularization (TVR non-TLR), thrombosis and stroke
Measured: At the end of PCI
EFFICACY: Other variables related to stent expansion. Minimal Lumen Area (MLA) in mm2
Cut-off point >5 mm2
Measured: At the end of PCI
EFFICACY: Other variables related to stent expansion. Minimal Lumen Area (MLA)
Percentage of Cut-off point >90 mm2
Measured: At the end of PCI
EFFICACY: Other variables related to stent expansion. Mean stent expansion
Percentage of mean stent area (sum of stent area/analyzed stent length)/mean reference lumen area (cut-off point>80%)
Measured: At the end of PCI
EFFICACY: Other variables related to stent expansion. Stent expansion using linear model
Percentage of stent volume/adaptative reference lumen volume. (cut-off point>65%)
Measured: At the end of PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start23 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736899
- Sponsor's protocol ID
- EPIC44-OraBil
- Acronym
- OraBil
- Status last verified
- Jul 2026
- First submitted
- 11 Dec 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Parikh K, Chandra P, Choksi N, Khanna P, Chambers J. Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions: the ORBIT I trial. Catheter Cardiovasc Interv. 2013 Jun 1;81(7):1134-9. doi: 10.1002/ccd.24700. Epub 2013 Mar 5.
PubMed 23460596Burzotta F, Louvard Y, Lassen JF, Lefevre T, Finet G, Collet C, Legutko J, Lesiak M, Hikichi Y, Albiero R, Pan M, Chatzizisis YS, Hildick-Smith D, Ferenc M, Johnson TW, Chieffo A, Darremont O, Banning A, Serruys PW, Stankovic G. Percutaneous coronary intervention for bifurcation coronary lesions using optimised angiographic guidance: the 18th consensus document from the European Bifurcation Club. EuroIntervention. 2024 Aug 5;20(15):e915-e926. doi: 10.4244/EIJ-D-24-00160.
PubMed 38752714den Dekker WK, Siskos AA, Wilschut JM, Nuis RJ, Scarparo P, Neleman T, Masdjedi K, Ligthart JMR, Diletti R, Daemen J, Van Mieghem NM. Initial experience with orbital atherectomy in a tertiary centre in the Netherlands. Neth Heart J. 2023 May;31(5):196-201. doi: 10.1007/s12471-022-01742-3. Epub 2022 Dec 12.
PubMed 36507948Donatelle M, Agasthi P, Parise H, Igyarto Z, Martinsen BJ, Leon MB, Beohar N. Coronary Orbital Atherectomy in Patients With Severe Aortic Stenosis. J Invasive Cardiol. 2022 Oct;34(10):E696-E700. doi: 10.25270/jic/22.00066.
PubMed 36200995Jurado-Román A, Gómez-Menchero A, Gonzalo N, et al. Plaque modification techniques to treat calcified coronary lesions. Position paper from the ACI-SEC. REC Interv Cardiol Engl Ed. Published online February 7, 2023:9672. doi:10.24875/RECICE.M22000345
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
- ClinicalTrials.gov ID
- NCT06736899
- Acronym / sponsor ID
- OraBil / EPIC44-OraBil
- Conditions
- Coronary Artery Disease, Coronary Disease
- Keywords
- Orbital Atherectomy (OA), Percutaneous Coronary Intervention, Bifurcation, Side Branch Treatment: Mid-term results
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Dec 2024 (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.
Clinical research with medical devices indicated in accordance with the CE marking, led by researchers, multicenter, open, prospective, randomized and controlled. Patients are randomized to treatment with a conventional balloon and then a coronary stent or to initial plaque modification with Orbital Atherectomy (OA) and then a coronary stent. To evaluate the efficacy and safety of OA in the adequate treatment with coronary stent of the calcified bifurcation lesion using angiography and optical coherence tomography (OCT).
Detailed description
The risk profile of patients and their comorbidities have worsened and the observed lesions undergoing treatment are increasingly complex. This has promoted the development of new technologies for plaque modification, especially in the context of calcified lesions. These predispose to suboptimal results of the intervention due to an increased risk of malapposition and underexpansion of the stents, the main variables for restenosis and/or thrombosis of the stents. Thus, compared with non-calcified lesions, the increased amount of calcium in the coronary artery leads to a higher incidence of major adverse cardiac events (MACE).
Coronary bifurcation stenting remains complex and is associated with a high risk of stent thrombosis and restenosis even with contemporary techniques, and suboptimal outcomes are frequently observed due to side branch (SL) involvement that increases cardiovascular events.
Our hypothesis is that the use of orbital atherectomy (OA) for coronary revascularization in the presence of calcified bifurcation lesions is feasible and safe compared to the more common technique, favoring the subsequent performance of provisional stenting (PS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon Angioplasty (BA) | Active comparator | Device: Balloon System Treatment |
| Orbital Atherectomy (OA) | Active comparator | Device: Orbital Atherectomy System Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age and
- Patients with moderately or severely calcified bifurcation lesions (lateral vessel ≥ 2mm), candidates for PCI with coronary stent implantation, in whom there is the possibility of adequate clinical follow-up at 1 year and
- Patients agree to participate in the study, by signing the Informed Consent.
Key exclusion criteria (9 listed)
- Patients with revascularization of the artery to be treated within 9 months prior to the index procedure.
- Patients with contraindication for the use of Orbital Atherectomy:
- Patients with life expectancy less than one year.
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 |
|---|---|---|
| Orbital Atherectomy System TreatmentPercutaneous coronary intervention of a calcified bifurcation coronary lesion with balloon angioplasty followed by drug eluting stent. Selection of balloon type is at operator´s discretion. Baseline and post dilation OCT will be performed. | Device | Orbital Atherectomy (OA) |
| Balloon System TreatmentPercutaneous coronary intervention of a calcified bifurcation coronary lesion with Orbital Atherectomy followed by drug eluting stent. Baseline and post dilation OCT will be performed. | Device | Balloon Angioplasty (BA) |
Primary outcome
EFFICACY: Angiographic criteria success
Time frame: At the end of PCI (Percutaneous Coronary Intervention)
Percentage of Main vessel and side branch (≥2 mm) patency (final stenosis <20%) without the presence of: residual lesion >70% and TIMI flow < 3 and residual ≥ type C disection
EFFICACY: OCT criteria: Stent expansion
Time frame: At the end of PCI
Percentage of MLA / mean reference luminal area (mean proximal and distal reference luminal)
8 secondary outcomes
SAFETY:Major adverse cardiac events (MACE)
Time frame: 12 months
SAFETY:Major adverse cardiac events (MACE)
Time frame: 6 months
SAFETY:Major adverse cardiac events (MACE)
Time frame: 30 days
SAFETY:Major adverse cardiac events (MACE)
Time frame: At the end of PCI
EFFICACY: Other variables related to stent expansion. Minimal Lumen Area (MLA) in mm2
Time frame: At the end of PCI
EFFICACY: Other variables related to stent expansion. Minimal Lumen Area (MLA)
Time frame: At the end of PCI
EFFICACY: Other variables related to stent expansion. Mean stent expansion
Time frame: At the end of PCI
EFFICACY: Other variables related to stent expansion. Stent expansion using linear model
Time frame: At the end of PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 23460596Parikh K, Chandra P, Choksi N, Khanna P, Chambers J. Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions: the ORBIT I trial. Catheter Cardiovasc Interv. 2013 Jun 1;81(7):1134-9. doi: 10.1002/ccd.24700. Epub 2013 Mar 5.
- Background: PubMed 38752714Burzotta F, Louvard Y, Lassen JF, Lefevre T, Finet G, Collet C, Legutko J, Lesiak M, Hikichi Y, Albiero R, Pan M, Chatzizisis YS, Hildick-Smith D, Ferenc M, Johnson TW, Chieffo A, Darremont O, Banning A, Serruys PW, Stankovic G. Percutaneous coronary intervention for bifurcation coronary lesions using optimised angiographic guidance: the 18th consensus document from the European Bifurcation Club. EuroIntervention. 2024 Aug 5;20(15):e915-e926. doi: 10.4244/EIJ-D-24-00160.
- Background: PubMed 36507948den Dekker WK, Siskos AA, Wilschut JM, Nuis RJ, Scarparo P, Neleman T, Masdjedi K, Ligthart JMR, Diletti R, Daemen J, Van Mieghem NM. Initial experience with orbital atherectomy in a tertiary centre in the Netherlands. Neth Heart J. 2023 May;31(5):196-201. doi: 10.1007/s12471-022-01742-3. Epub 2022 Dec 12.
- Background: PubMed 36200995Donatelle M, Agasthi P, Parise H, Igyarto Z, Martinsen BJ, Leon MB, Beohar N. Coronary Orbital Atherectomy in Patients With Severe Aortic Stenosis. J Invasive Cardiol. 2022 Oct;34(10):E696-E700. doi: 10.25270/jic/22.00066.
- BackgroundJurado-Román A, Gómez-Menchero A, Gonzalo N, et al. Plaque modification techniques to treat calcified coronary lesions. Position paper from the ACI-SEC. REC Interv Cardiol Engl Ed. Published online February 7, 2023:9672. doi:10.24875/RECICE.M22000345
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orbital Atherectomy System Treatment and Balloon System Treatment in people with Coronary Artery Disease and Coronary Disease, run by Fundación EPIC at 9 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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JORGE PALAZUELOS, MD, PhD (0034659768506, jpalaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFFICACY: Angiographic criteria success (time frame: At the end of PCI (Percutaneous Coronary Intervention)). The study lists 2 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 NCT06736899, which also lists 5 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 8 Jul 2026.