Coronary Arterial Disease (CAD)ORBIT-SHOCKNCT06736665
Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).
A study testing Orbital atherectomy, Intravascular lithotripsy and Optical Coherence Tomography (OCT) in people with Coronary Arterial Disease (CAD) and Coronary Calcification, run by Spanish Society of Cardiology at 6 sites in Spain.
Trial summary
The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), Coronary Calcification, Coronary Calcified Nodules
- What is being tested?
- Orbital atherectomy, Intravascular lithotripsy and Optical Coherence Tomography (OCT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesSpain
- Study dates
- 12 Jun 2025to Dec 2027
- 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 aged ≥ 18 years.
- Atherosclerotic coronary artery disease with calcified nodules identified by OCT in a native vessel, eligible for percutaneous coronary revascularization.
- Clinical presentation of chronic coronary syndrome or acute coronary syndrome without ST elevation*.
- Distal vessel reference diameters ≥ 2.5 mm and ≤ 4.0 mm. * Non-culprit lesions eligible for revascularization in a staged procedure following a ST-elevation myocardial infarction (STEMI) are considered for inclusion.
Who cannot join
- Culprit lesions in acute coronary syndrome with ST elevation.
- Left main disease.
- In-stent restenosis lesions.
- Critical stenoses where it is not possible to advance the OCT catheter across the lesion after predilation with a balloon of up to 2 mm in diameter.
- Lesion involving a bifurcation with a secondary branch diameter ≥2 mm.
- Cardiogenic shock.
Show all 14Show fewer
- Patients requiring cardiac surgery or percutaneous valve intervention within three months before or after angioplasty.
- Pregnancy.
- Life expectancy of less than one year.
- Contraindication for the use of appropriate antiplatelet therapy post-revascularization.
- Coronary artery disease with an indication for surgical revascularization.
- Advanced chronic kidney disease or anatomical characteristics that contraindicate the use of optical coherence tomography.
- Inability to obtain informed consent.
- Allergy to eggs or soy, contraindicating the use of OA.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitario General de Alicante
Alicante, Alicante, 03010
José Valencia-Martín, MD, PhD., 0034 699 43 83 76, jvalenciam@hotmail.com
José Valencia-Martín, MD, PhD.
- Recruiting
Hospital Universitario Reina Sofía de Córdoba
Córdoba
Manuel Pan, MD, PhD., 0034 676 99 91 44, manuelpanalvarez@gmail.com
Manuel Pan, MD, PhD.
- Recruiting
Hospital Universitario Lucus Augusti
Lugo, Lugo, 27003
Jeremías Bayón Lorenzo, MD, PhD., 0034 657 51 45 08, jerebayon@gmail.com
Jeremías Bayón Lorenzo, MD, PhD.
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Ángel Sánchez-Recalde, MD, PhD., 0034 676 59 95 32, asrecalde@hotmail.com
Luis Manuel Domínguez-Rodríguez, MD., 0034 639 82 56 65, luis-s-ma@hotmail.com
- Recruiting
Hospital Universitario de Salamanca
Salamanca, Salamanca, 37007
Javier Martín-Moreiras, MD, PhD., 0034 629 25 31 16, jmmoreiras@gmail.com
Javier Martín-Moreiras, MD, PhD.
- Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47003
Jesús Ignacio Amat-Santos, MD, PhD., 0034 657 92 30 40, ijamat@gmail.com
Jesús Ignacio Amat-Santos, MD, PhD.
About this study
Official title: Comparative Efficacy of Orbital Atherectomy and Intravascular Lithotripsy in the Treatment of Calcified Coronary Nodules. The ORBIT-SHOCK Pilot Study.
The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI).
Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).
Read more
The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).
The aim of this pilot trial is to compare PCI outcomes and the incidence of adverse events between both techniques.
Read the detailed description
Coronary calcification in the form of calcified nodules (CN) is systematically associated with worse outcomes due to the difficulty in adequately dilation of the lesion and the inability to properly fracture the calcium nodule before stent implantation.
The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting CNs, identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI).
Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).
Primary endpoint: Compare both techniques in terms of achieving adequate stent expansion, measured by OCT.
Secondary endpoints: Evaluate procedural and strategy success rates, assess their impact on calcium nodule modification, and monitor the incidence of adverse clinical events at 12 months.
Patients will be monitored for 12 months after the procedure to assess the incidence of adverse events during follow-up.
- Conditions
- Coronary Arterial Disease (CAD), Coronary Calcification, Coronary Calcified Nodules, Orbital Atherectomy, Intravascular Lithotripsy, Optical Coherence Tomography (OCT)
- Being tested
- Orbital atherectomy, Intravascular lithotripsy, Optical Coherence Tomography (OCT), Percutaneous coronary intervention with stent implantation
- Keywords
- Coronary arterial disease, Coronary calcification, Coronary calcified nodules, Orbital atherectomy, Intravascular lithotripsy, Optical Coherence Tomography (OCT), Percutaneous Coronary Intervention (PCI), Chronic Coronary Syndrome, Acute Coronary Syndrome (ACS), ORBIT-SHOCK, ORBIT SHOCK
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orbital atherectomyDevice
The Diamondback-360 (OAS) (Abbott) device is used to perform this technique, consisting of a bidirectional, diamond-coated orbital crown that utilizes a combination of centrifugal force (creating elliptical orbits) and surface abrasion to modify the calcified plaque and increase distensibility. Additionally, the pulsatile impact of the crown at high speed can create microfractures in deep calcium. As a result, a single 1.25 mm crown can treat vessels ranging from 2.5 to 4 mm in diameter.
Intravascular lithotripsyDevice
Also called Shockwave
The Shockwave Medical Intravascular Lithotripsy System (Shockwave Medical) is a balloon that emits pulsatile sonic waves capable of fracturing intracoronary calcium. This therapy is administered by advancing a catheter and inflating the balloon at low pressure to deliver sonic pulses.
Optical Coherence Tomography (OCT)Device
Optical Coherence Tomography (OCT) is an intravascular imaging modality that uses near-infrared light to provide high-definition, cross-sectional and three-dimensional images of the vessel microstructure.
These images provide additional information on the degree and characteristics of coronary artery disease compared to angiography which doesn't delineate the composition of the coronary artery. With automated, highly accurate measurements, OCT can guide stent selection, placement, and deployment.
Percutaneous coronary intervention with stent implantationDevice
All patients will undergo percutaneous coronary intervention with drug-eluting stent implantation after plaque modification using the technique assigned by randomization.
| Study group | Role | What they receive |
|---|---|---|
| Orbital atherectomy | Active comparator | The Diamondback-360 (OAS) (Abbott) device is used to perform this technique, consisting of a bidirectional, diamond-coated orbital crown that utilizes a combination of centrifugal force (creating elliptical orbits) and surface abrasion to modify the calcified plaque and increase distensibility. Additionally, the pulsatile impact of the crown at high speed can create microfractures in deep calcium. As a result, a single 1.25 mm crown can treat vessels ranging from 2.5 to 4 mm in diameter. Receives: Device: Orbital atherectomy; Device: Optical Coherence Tomography (OCT); Device: Percutaneous coronary intervention with stent implantation |
| Intravascular lithotripsy | Active comparator | The Shockwave Medical Intravascular Lithotripsy System (Shockwave Medical) is a balloon that emits pulsatile sonic waves capable of fracturing intracoronary calcium. This therapy is administered by advancing a catheter and inflating the balloon at low pressure to deliver sonic pulses. Receives: Device: Intravascular lithotripsy; Device: Optical Coherence Tomography (OCT); Device: Percutaneous coronary intervention with stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent expansion
Percentage of stent expansion at the CN site: measured with OCT, defined as the ratio between the minimum stent area at the CN site and the average of the distal and proximal reference areas.
Measured: At the end of percutaneous coronary intervention
Secondary outcomes (12)
Procedural success
Achieving a stent expansion of ≥ 80% with TIMI III flow, in the absence of stent loss, coronary perforation, or intraprocedural death.
Measured: At the end of percutaneous coronary intervention
Strategy success
Defined as procedural success without the need for crossover to an alternative treatment.
Measured: At the end of percutaneous coronary intervention
Minimum stent area
Minimum stent area (MSA)
Measured: At the end of percutaneous coronary intervention
Minimum stent area at the CN site.
Minimum stent area at the CN site.
Measured: At the end of percutaneous coronary intervention
Significant stent malapposition at the CN site
Measured using OCT, defined as a stent strut detachment ≥ 0.4 mm from the underlying vessel wall, with a longitudinal extension ≥ 1 mm.
Measured: At the end of percutaneous coronary intervention
Degree of calcium nodule debulking
Reduction in calcium nodule size (mm²), measured after plaque modification and prior to stent implantation.
Measured: At the end of percutaneous coronary intervention
Evidence of fracture at the CN site
Evidence of new disruption or discontinuity observed on OCT after plaque modification and prior to stent implantation.
Measured: At the end of percutaneous coronary intervention
Degree of stent ellipticity at the CN site
Measured using OCT at the end of the procedure, calculated as the ratio of the maximum luminal diameter to the minimum luminal diameter of the stent at the CN site.
Measured: At the end of percutaneous coronary intervention
Residual luminal protrusion of the calcium nodule following stent implantation
Residual luminal protrusion of the calcium nodule following stent implantation, measured by OCT in mm2.
Measured: At the end of percutaneous coronary intervention
Target lesion failure (TLF) at 12 months
Composite of clinically driven target lesion revascularization, myocardial infarction or cardiac death related to the target lesion.
Measured: At 12 months
Target lesion revascularization (TLR) at 12 months
Repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Measured: At 12 months
Major Adverse Cardiovascular Events (MACE) at 12 months
Defined as a composite of cardiovascular death, non-fatal target lesion myocardial infarction, unplanned target lesion revascularization or stent thrombosis.
Measured: At 12 months
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 start12 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Coronary Arterial Disease (CAD)Studies 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
- Model description
- Once the presence of a calcified nodular lesion is confirmed and the patient meets the inclusion criteria without any exclusion criteria, the patient will be randomized to one of the two treatment techniques being evaluated in the study (OA vs. IVL) in a 1:1 ratio. A stratified randomization will be implemented based on the type of calcified nodule (eruptive or non-eruptive) to ensure equal proportions of each type between the two treatment groups.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spanish Society of Cardiology
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Luis Manuel Domínguez Rodríguez, Spanish Society of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736665
- Sponsor's protocol ID
- ORBIT-SHOCK
- Acronym
- ORBIT-SHOCK
- Status last verified
- Apr 2026
- First submitted
- 12 Dec 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
PubMed 21670242Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. J Am Coll Cardiol. 2017 Feb 14;69(6):679-691. doi: 10.1016/j.jacc.2016.11.045.
PubMed 28183511Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; ESC Scientific Document Group. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019 Jan 14;40(3):237-269. doi: 10.1093/eurheartj/ehy462. No abstract available.
PubMed 30165617Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Eur Heart J. 2018 Jun 14;39(23):2192-2207. doi: 10.1093/eurheartj/ehy223.
PubMed 29897428Maehara A, Ben-Yehuda O, Ali Z, Wijns W, Bezerra HG, Shite J, Genereux P, Nichols M, Jenkins P, Witzenbichler B, Mintz GS, Stone GW. Comparison of Stent Expansion Guided by Optical Coherence Tomography Versus Intravascular Ultrasound: The ILUMIEN II Study (Observational Study of Optical Coherence Tomography [OCT] in Patients Undergoing Fractional Flow Reserve [FFR] and Percutaneous Coronary Intervention). JACC Cardiovasc Interv. 2015 Nov;8(13):1704-14. doi: 10.1016/j.jcin.2015.07.024.
PubMed 26585621Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
PubMed 39210710Holm NR, Andreasen LD, Neghabat O, Laanmets P, Kumsars I, Bennett J, Olsen NT, Odenstedt J, Hoffmann P, Dens J, Chowdhary S, O'Kane P, Bulow Rasmussen SH, Heigert M, Havndrup O, Van Kuijk JP, Biscaglia S, Mogensen LJH, Henareh L, Burzotta F, H Eek C, Mylotte D, Llinas MS, Koltowski L, Knaapen P, Calic S, Witt N, Santos-Pardo I, Watkins S, Lonborg J, Kristensen AT, Jensen LO, Calais F, Cockburn J, McNeice A, Kajander OA, Heestermans T, Kische S, Eftekhari A, Spratt JC, Christiansen EH; OCTOBER Trial Group. OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions. N Engl J Med. 2023 Oct 19;389(16):1477-1487. doi: 10.1056/NEJMoa2307770. Epub 2023 Aug 27.
PubMed 37634149Ali ZA, Landmesser U, Maehara A, Matsumura M, Shlofmitz RA, Guagliumi G, Price MJ, Hill JM, Akasaka T, Prati F, Bezerra HG, Wijns W, Leistner D, Canova P, Alfonso F, Fabbiocchi F, Dogan O, McGreevy RJ, McNutt RW, Nie H, Buccola J, West NEJ, Stone GW; ILUMIEN IV Investigators. Optical Coherence Tomography-Guided versus Angiography-Guided PCI. N Engl J Med. 2023 Oct 19;389(16):1466-1476. doi: 10.1056/NEJMoa2305861. Epub 2023 Aug 27.
PubMed 37634188Lee JM, Choi KH, Song YB, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Jeong JO, Song PS, Doh JH, Jo SH, Yoon CH, Kang MG, Koh JS, Lee KY, Lim YH, Cho YH, Cho JM, Jang WJ, Chun KJ, Hong D, Park TK, Yang JH, Choi SH, Gwon HC, Hahn JY; RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging-Guided or Angiography-Guided Complex PCI. N Engl J Med. 2023 May 4;388(18):1668-1679. doi: 10.1056/NEJMoa2216607. Epub 2023 Mar 5.
PubMed 36876735Shin D, Dakroub A, Singh M, Malik S, Sakai K, Maehara A, Shlofmitz E, Jeremias A, Shlofmitz RA, Ali ZA. Debulking Effect of Orbital Atherectomy for Calcified Nodule Assessed by Optical Coherence Tomography. Circ Cardiovasc Interv. 2024 Aug;17(8):e014145. doi: 10.1161/CIRCINTERVENTIONS.124.014145. Epub 2024 Jul 1. No abstract available.
PubMed 38946577Chiang CSM, Alan Chan KC, Lee M, Chan KT. Orbital-Tripsy: Novel Combination of Orbital-Atherectomy and Intravascular-Lithotripsy, in Calcified Coronaries After Failed Intravascular-Lithotripsy. JACC Case Rep. 2020 Dec 16;2(15):2437-2444. doi: 10.1016/j.jaccas.2020.10.027. eCollection 2020 Dec.
PubMed 34317190Rola P, Wlodarczak S, Barycki M, Furtan L, Jastrzebski A, Kedzierska M, Doroszko A, Lesiak M, Wlodarczak A. Safety and Efficacy of Orbital Atherectomy in the All-Comer Population: Mid-Term Results of the Lower Silesian Orbital Atherectomy Registry (LOAR). J Clin Med. 2023 Sep 8;12(18):5842. doi: 10.3390/jcm12185842.
PubMed 37762782Okamoto N, Ueda H, Bhatheja S, Vengrenyuk Y, Aquino M, Rabiei S, Barman N, Kapur V, Hasan C, Mehran R, Baber U, Kini AS, Sharma SK. Procedural and one-year outcomes of patients treated with orbital and rotational atherectomy with mechanistic insights from optical coherence tomography. EuroIntervention. 2019 Apr 20;14(17):1760-1767. doi: 10.4244/EIJ-D-17-01060.
PubMed 29957595Yamamoto MH, Maehara A, Karimi Galougahi K, Mintz GS, Parviz Y, Kim SS, Koyama K, Amemiya K, Kim SY, Ishida M, Losquadro M, Kirtane AJ, Haag E, Sosa FA, Stone GW, Moses JW, Ochiai M, Shlofmitz RA, Ali ZA. Mechanisms of Orbital Versus Rotational Atherectomy Plaque Modification in Severely Calcified Lesions Assessed by Optical Coherence Tomography. JACC Cardiovasc Interv. 2017 Dec 26;10(24):2584-2586. doi: 10.1016/j.jcin.2017.09.031. No abstract available.
PubMed 29268891Yamamoto MH, Maehara A, Kim SS, Koyama K, Kim SY, Ishida M, Fujino A, Haag ES, Alexandru D, Jeremias A, Sosa FA, Karimi Galougahi K, Kirtane AJ, Moses JW, Ali ZA, Mintz GS, Shlofmitz RA. Effect of orbital atherectomy in calcified coronary artery lesions as assessed by optical coherence tomography. Catheter Cardiovasc Interv. 2019 Jun 1;93(7):1211-1218. doi: 10.1002/ccd.27902. Epub 2018 Oct 17.
PubMed 30328257
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Orbital Atherectomy and Intravascular Lithotripsy in the Treatment of Calcified Coronary Nodules. The ORBIT-SHOCK Pilot Study.
- ClinicalTrials.gov ID
- NCT06736665
- Acronym / sponsor ID
- ORBIT-SHOCK / ORBIT-SHOCK
- Conditions
- Coronary Arterial Disease (CAD), Coronary Calcification, Coronary Calcified Nodules, Orbital Atherectomy, Intravascular Lithotripsy, Optical Coherence Tomography (OCT)
- Keywords
- Coronary arterial disease, Coronary calcification, Coronary calcified nodules, Orbital atherectomy, Intravascular lithotripsy, Optical Coherence Tomography (OCT), Percutaneous Coronary Intervention (PCI), Chronic Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Spanish Society of CardiologyUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (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.
The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI).
Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).
The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).
The aim of this pilot trial is to compare PCI outcomes and the incidence of adverse events between both techniques.
Detailed description
Coronary calcification in the form of calcified nodules (CN) is systematically associated with worse outcomes due to the difficulty in adequately dilation of the lesion and the inability to properly fracture the calcium nodule before stent implantation.
The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting CNs, identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI).
Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).
Primary endpoint: Compare both techniques in terms of achieving adequate stent expansion, measured by OCT.
Secondary endpoints: Evaluate procedural and strategy success rates, assess their impact on calcium nodule modification, and monitor the incidence of adverse clinical events at 12 months.
Patients will be monitored for 12 months after the procedure to assess the incidence of adverse events during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Once the presence of a calcified nodular lesion is confirmed and the patient meets the inclusion criteria without any exclusion criteria, the patient will be randomized to one of the two treatment techniques being evaluated in the study (OA vs. IVL) in a 1:1 ratio. A stratified randomization will be implemented based on the type of calcified nodule (eruptive or non-eruptive) to ensure equal proportions of each type between the two treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Orbital atherectomy | Active comparator | Device: Orbital atherectomy, Device: Optical Coherence Tomography (OCT), Device: Percutaneous coronary intervention with stent implantationThe Diamondback-360 (OAS) (Abbott) device is used to perform this technique, consisting of a bidirectional, diamond-coated orbital crown that utilizes a combination of centrifugal force (creating elliptical orbits) and surface abrasion to modify the calcified plaque and increase distensibility. Additionally, the pulsatile impact of the crown at high speed can create microfractures in deep calcium. As a result, a single 1.25 mm crown can treat vessels ranging from 2.5 to 4 mm in diameter. |
| Intravascular lithotripsy | Active comparator | Device: Intravascular lithotripsy, Device: Optical Coherence Tomography (OCT), Device: Percutaneous coronary intervention with stent implantationThe Shockwave Medical Intravascular Lithotripsy System (Shockwave Medical) is a balloon that emits pulsatile sonic waves capable of fracturing intracoronary calcium. This therapy is administered by advancing a catheter and inflating the balloon at low pressure to deliver sonic pulses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥ 18 years.
- Atherosclerotic coronary artery disease with calcified nodules identified by OCT in a native vessel, eligible for percutaneous coronary revascularization.
- Clinical presentation of chronic coronary syndrome or acute coronary syndrome without ST elevation*.
- Distal vessel reference diameters ≥ 2.5 mm and ≤ 4.0 mm. * Non-culprit lesions eligible for revascularization in a staged procedure following a ST-elevation myocardial infarction (STEMI) are considered for inclusion.
Key exclusion criteria (14 listed)
- Culprit lesions in acute coronary syndrome with ST elevation.
- Left main disease.
- In-stent restenosis lesions.
- Critical stenoses where it is not possible to advance the OCT catheter across the lesion after predilation with a balloon of up to 2 mm in diameter.
- Lesion involving a bifurcation with a secondary branch diameter ≥2 mm.
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 atherectomyThe Diamondback-360 (OAS) (Abbott) device is used to perform this technique, consisting of a bidirectional, diamond-coated orbital crown that utilizes a combination of centrifugal force (creating elliptical orbits) and surface abrasion to modify the calcified plaque and increase distensibility. Additionally, the pulsatile impact of the crown at high speed can create microfractures in deep calcium. As a result, a single 1.25 mm crown can treat vessels ranging from 2.5 to 4 mm in diameter. | Device | Orbital atherectomy |
| Intravascular lithotripsyAlso: ShockwaveThe Shockwave Medical Intravascular Lithotripsy System (Shockwave Medical) is a balloon that emits pulsatile sonic waves capable of fracturing intracoronary calcium. This therapy is administered by advancing a catheter and inflating the balloon at low pressure to deliver sonic pulses. | Device | Intravascular lithotripsy |
| Optical Coherence Tomography (OCT)Optical Coherence Tomography (OCT) is an intravascular imaging modality that uses near-infrared light to provide high-definition, cross-sectional and three-dimensional images of the vessel microstructure. These images provide additional information on the degree and characteristics of coronary artery disease compared to angiography which doesn't delineate the composition of the coronary artery. With automated, highly accurate measurements, OCT can guide stent selection, placement, and deployment. | Device | Intravascular lithotripsy, Orbital atherectomy |
| Percutaneous coronary intervention with stent implantationAll patients will undergo percutaneous coronary intervention with drug-eluting stent implantation after plaque modification using the technique assigned by randomization. | Device | Intravascular lithotripsy, Orbital atherectomy |
Primary outcome
Stent expansion
Time frame: At the end of percutaneous coronary intervention
Percentage of stent expansion at the CN site: measured with OCT, defined as the ratio between the minimum stent area at the CN site and the average of the distal and proximal reference areas.
12 secondary outcomes
Procedural success
Time frame: At the end of percutaneous coronary intervention
Strategy success
Time frame: At the end of percutaneous coronary intervention
Minimum stent area
Time frame: At the end of percutaneous coronary intervention
Minimum stent area at the CN site.
Time frame: At the end of percutaneous coronary intervention
Significant stent malapposition at the CN site
Time frame: At the end of percutaneous coronary intervention
Degree of calcium nodule debulking
Time frame: At the end of percutaneous coronary intervention
Evidence of fracture at the CN site
Time frame: At the end of percutaneous coronary intervention
Degree of stent ellipticity at the CN site
Time frame: At the end of percutaneous coronary intervention
Residual luminal protrusion of the calcium nodule following stent implantation
Time frame: At the end of percutaneous coronary intervention
Target lesion failure (TLF) at 12 months
Time frame: At 12 months
Target lesion revascularization (TLR) at 12 months
Time frame: At 12 months
Major Adverse Cardiovascular Events (MACE) at 12 months
Time frame: At 12 months
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 30 Apr 2026.
- Results publication: PubMed 21670242Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
- Results publication: PubMed 28183511Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. J Am Coll Cardiol. 2017 Feb 14;69(6):679-691. doi: 10.1016/j.jacc.2016.11.045.
- Results publication: PubMed 30165617Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; ESC Scientific Document Group. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019 Jan 14;40(3):237-269. doi: 10.1093/eurheartj/ehy462. No abstract available.
- Results publication: PubMed 29897428Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Eur Heart J. 2018 Jun 14;39(23):2192-2207. doi: 10.1093/eurheartj/ehy223.
- Results publication: PubMed 26585621Maehara A, Ben-Yehuda O, Ali Z, Wijns W, Bezerra HG, Shite J, Genereux P, Nichols M, Jenkins P, Witzenbichler B, Mintz GS, Stone GW. Comparison of Stent Expansion Guided by Optical Coherence Tomography Versus Intravascular Ultrasound: The ILUMIEN II Study (Observational Study of Optical Coherence Tomography [OCT] in Patients Undergoing Fractional Flow Reserve [FFR] and Percutaneous Coronary Intervention). JACC Cardiovasc Interv. 2015 Nov;8(13):1704-14. doi: 10.1016/j.jcin.2015.07.024.
- Results publication: PubMed 39210710Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
- Results publication: PubMed 37634149Holm NR, Andreasen LD, Neghabat O, Laanmets P, Kumsars I, Bennett J, Olsen NT, Odenstedt J, Hoffmann P, Dens J, Chowdhary S, O'Kane P, Bulow Rasmussen SH, Heigert M, Havndrup O, Van Kuijk JP, Biscaglia S, Mogensen LJH, Henareh L, Burzotta F, H Eek C, Mylotte D, Llinas MS, Koltowski L, Knaapen P, Calic S, Witt N, Santos-Pardo I, Watkins S, Lonborg J, Kristensen AT, Jensen LO, Calais F, Cockburn J, McNeice A, Kajander OA, Heestermans T, Kische S, Eftekhari A, Spratt JC, Christiansen EH; OCTOBER Trial Group. OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions. N Engl J Med. 2023 Oct 19;389(16):1477-1487. doi: 10.1056/NEJMoa2307770. Epub 2023 Aug 27.
- Results publication: PubMed 37634188Ali ZA, Landmesser U, Maehara A, Matsumura M, Shlofmitz RA, Guagliumi G, Price MJ, Hill JM, Akasaka T, Prati F, Bezerra HG, Wijns W, Leistner D, Canova P, Alfonso F, Fabbiocchi F, Dogan O, McGreevy RJ, McNutt RW, Nie H, Buccola J, West NEJ, Stone GW; ILUMIEN IV Investigators. Optical Coherence Tomography-Guided versus Angiography-Guided PCI. N Engl J Med. 2023 Oct 19;389(16):1466-1476. doi: 10.1056/NEJMoa2305861. Epub 2023 Aug 27.
- Results publication: PubMed 36876735Lee JM, Choi KH, Song YB, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Jeong JO, Song PS, Doh JH, Jo SH, Yoon CH, Kang MG, Koh JS, Lee KY, Lim YH, Cho YH, Cho JM, Jang WJ, Chun KJ, Hong D, Park TK, Yang JH, Choi SH, Gwon HC, Hahn JY; RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging-Guided or Angiography-Guided Complex PCI. N Engl J Med. 2023 May 4;388(18):1668-1679. doi: 10.1056/NEJMoa2216607. Epub 2023 Mar 5.
- Results publication: PubMed 38946577Shin D, Dakroub A, Singh M, Malik S, Sakai K, Maehara A, Shlofmitz E, Jeremias A, Shlofmitz RA, Ali ZA. Debulking Effect of Orbital Atherectomy for Calcified Nodule Assessed by Optical Coherence Tomography. Circ Cardiovasc Interv. 2024 Aug;17(8):e014145. doi: 10.1161/CIRCINTERVENTIONS.124.014145. Epub 2024 Jul 1. No abstract available.
- Results publication: PubMed 34317190Chiang CSM, Alan Chan KC, Lee M, Chan KT. Orbital-Tripsy: Novel Combination of Orbital-Atherectomy and Intravascular-Lithotripsy, in Calcified Coronaries After Failed Intravascular-Lithotripsy. JACC Case Rep. 2020 Dec 16;2(15):2437-2444. doi: 10.1016/j.jaccas.2020.10.027. eCollection 2020 Dec.
- Results publication: PubMed 37762782Rola P, Wlodarczak S, Barycki M, Furtan L, Jastrzebski A, Kedzierska M, Doroszko A, Lesiak M, Wlodarczak A. Safety and Efficacy of Orbital Atherectomy in the All-Comer Population: Mid-Term Results of the Lower Silesian Orbital Atherectomy Registry (LOAR). J Clin Med. 2023 Sep 8;12(18):5842. doi: 10.3390/jcm12185842.
- Individual participant dataSharing planned: Undecided
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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.
6 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, Intravascular lithotripsy and Optical Coherence Tomography (OCT) in people with Coronary Arterial Disease (CAD) and Coronary Calcification, run by Spanish Society of Cardiology at 6 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 14 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 Ángel Sánchez-Recalde, MD, PhD. (0034 676 59 95 32, asrecalde@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent expansion (time frame: At the end of percutaneous coronary intervention). 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 NCT06736665, which also lists 27 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 30 Apr 2026.