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Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

NCT ID: NCT06736899

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-23

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Coronary Artery Disease Coronary Disease

Keywords

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Orbital Atherectomy (OA) Percutaneous Coronary Intervention Bifurcation Side Branch Treatment: Mid-term results

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Balloon Angioplasty (BA)

Group Type ACTIVE_COMPARATOR

Balloon System Treatment

Intervention Type DEVICE

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.

Orbital Atherectomy (OA)

Group Type ACTIVE_COMPARATOR

Orbital Atherectomy System Treatment

Intervention Type DEVICE

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.

Interventions

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Orbital Atherectomy System Treatment

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.

Intervention Type DEVICE

Balloon System Treatment

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* Patients with severe left ventricular dysfunction.
* Patients allergic to the components of the washing serum (glide).
* Patients with life expectancy less than one year.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación EPIC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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H. G.U. de ALICANTE DR. BALMIS

Alicante, , Spain

Site Status RECRUITING

Hospital Universitario Lucus Augusti

Lugo, , Spain

Site Status RECRUITING

Hospital Universitario La Luz

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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JORGE PALAZUELOS, MD, PhD

Role: CONTACT

Phone: 0034659768506

Email: [email protected]

FUNDACION EPIC

Role: CONTACT

Phone: 0034987876135

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 23460596 (View on PubMed)

Burzotta 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.

Reference Type BACKGROUND
PMID: 38752714 (View on PubMed)

den 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.

Reference Type BACKGROUND
PMID: 36507948 (View on PubMed)

Donatelle 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.

Reference Type BACKGROUND
PMID: 36200995 (View on PubMed)

Jurado-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

Reference Type BACKGROUND

Other Identifiers

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EPIC44-OraBil

Identifier Type: -

Identifier Source: org_study_id