NCT06736899

Brief 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) 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
8mo left

Started Oct 2025

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Oct 2025Dec 2026

First Submitted

Initial submission to the registry

December 11, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

October 23, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

December 11, 2024

Last Update Submit

April 15, 2026

Conditions

Coronary Artery DiseaseCoronary Disease

Keywords

Orbital Atherectomy (OA)Percutaneous Coronary InterventionBifurcationSide Branch Treatment: Mid-term results

Outcome Measures

Primary Outcomes (2)

  • 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

    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)

    At the end of PCI

Secondary Outcomes (8)

  • SAFETY:Major adverse cardiac events (MACE)

    12 months

  • SAFETY:Major adverse cardiac events (MACE)

    6 months

  • SAFETY:Major adverse cardiac events (MACE)

    30 days

  • SAFETY:Major adverse cardiac events (MACE)

    At the end of PCI

  • EFFICACY: Other variables related to stent expansion. Minimal Lumen Area (MLA) in mm2

    At the end of PCI

  • +3 more secondary outcomes

Study Arms (2)

Balloon Angioplasty (BA)

ACTIVE COMPARATOR
Device: Balloon System Treatment

Orbital Atherectomy (OA)

ACTIVE COMPARATOR
Device: Orbital Atherectomy System Treatment

Interventions

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.

Orbital Atherectomy (OA)
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.

Balloon Angioplasty (BA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

H. G.U. de ALICANTE DR. BALMIS

Alicante, 03010, Spain

RECRUITING

H. de La Santa Creu I Sant Pau

Barcelona, 08041, Spain

RECRUITING

Hospital Universitario La Paz

Fuencarral-El Pardo, 28046, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, 270003, Spain

RECRUITING

Hospital Universitario La Luz

Madrid, 28003, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

RECRUITING

Related Publications (5)

  • 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.

    PMID: 23460596BACKGROUND

  • 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.

    PMID: 38752714BACKGROUND

  • 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.

    PMID: 36507948BACKGROUND

  • 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.

    PMID: 36200995BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

JORGE PALAZUELOS, MD, PhD

CONTACT

0034659768506jpalaz@gmail.com

FUNDACION EPIC

CONTACT

0034987876135iepic@fundacionepic.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2024

First Posted

December 17, 2024

Study Start

October 23, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

ES(6)