Coronary Artery CalcificationSCALPONCT05973994

Shockwave Induced Attenuation of Calcified Plaques Quantified With OCT

An observational study of Coronary Artery Calcification, run by University of Rome Tor Vergata at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The goal of this observational, prospective, multicenter study is to explore local action of coronary calcium fragmentation exerted by endovascular lithotripsy by images acquired with OCT, in patients with coronary artery calcifications responsible for significant stenosis, candidate to PCI. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Coronary Artery Calcification
What is being tested?: intravascular lithotripsy with Shockwave coronary system
Type of treatment: Medical device
How many people: 20 participants
Where: 1 siteItaly
Study dates: 21 Feb 2022to 30 Jun 2025
How long will I take part?: 6 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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: All patients in the Catheterization Laboratory that undergo coronary angiography, are potentially selected.

Who may be able to join

Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
Left ventricular ejection fraction (LVEF) ≥35% as measured prior to enrollment
eGFR ≥45 ml/min (Cockroft-Gault, MDRD)
Troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure or if troponin is elevated, concomitant CK must be normal
Ability to tolerate dual antiplatelet therapy (i.e. aspirin and clopidogrel, prasugrel, or ticagrelor) for at least 6 months (for patient not on oral anticoagulation) and single antiplatelet therapy for life
The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure

Show all 12Show fewer

Single de novo target lesion stenosis of LAD, RCA or LCX (or of their branches) with stenosis of ≥70% and <100% or stenosis ≥50% and <70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR <0.89 or IVUS or OCT minimum lumen area ≤4.0 mm²
Reference vessel must have 2.5 mm - 4.0 mm diameter and ≤ 30 mm length
Evidence of calcification at the lesion site assessed by angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, or by IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section
Planned treatment of single lesion for every target vessel
Ability to pass a 0.014" guide wire across the lesion
The target vessel must have a TIMI flow 3 at baseline

Who cannot join

Left ventricular ejection fraction (LVEF) <35%
Subject is pregnant or nursing
eGFR <45 ml/min (Cockroft-Gault, MDRD) or chronic dialysis
Untreated pre-procedural haemoglobin <9 g/dL or intention to refuse blood transfusions if one should become necessary
Patient has a platelet count <100,000 cells/mm3 or >750,000 cells/mm3
Patient has a known allergy to protocol required medications (clopidogrel, thienopyridines, aspirin, contrast media) that cannot be adequately premedicated

Show all 17Show fewer

Uncontrolled diabetes defined as a fasting hyperglycaemia >200 mg/dL or HbA1c greater than or equal to 10%
Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
Patient has an active peptic ulcer or active gastrointestinal (GI) bleeding
Patient has a history of coagulopathy
Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
Subjects with a life expectancy of less than 1 year
Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy
Stent implantation in the target vessel within the last year or a stent within 10 mm of the target lesion
Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
Angiographic evidence of a dissection in the target vessel at baseline or after guidewire passage

Trial locations and contacts

1 site in 1 country.

Italy1 site

University of Rome Tor Vergata - Policlinico
Roma, Rome, 00133

Other trials in Italy

About this study

Read the detailed description

Coronary arteries with calcific lesions will undergo intravasculary lithotripsy (IVL) treatment; OCT acquisition will be performed before IVL treatment, after IVL treatment and after stent-implantation. All OCT frames will be uploaded on the image processing and analysis program ImageJ (US National Institutes of Health). ROI will be selected as part of image where calcium is located. Image analysis will be performed using frequency histogram of pixel density in the ROI pre- and post-IVL, as a measure of calcium density. Mean pixel density of the ROI before IVL will be compared with mean pixel density of the ROI after IVL, measuring delta pixel density.

Conditions: Coronary Artery Calcification
Being tested: intravascular lithotripsy with Shockwave coronary system
Keywords: Coronary artery calcification, Intravascular Lithotripsy, Optical Coherence Tomography, Calcium density

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

intravascular lithotripsy with Shockwave coronary systemDevice
Also called OCT acquisition with FD-OCT imaging catheter
OCT acquistion is performed at baseline. Then the IVL catheter will be passed across the lesion over the guidewire. Atherectomy or cutting/scoring balloons is not permitted per protocol. The IVL procedure is considered successful when a residual stenosis <50% by visual estimate after IVL alone is achieved. After IVL procedure, one OCT imaging acquisition must be performed. If the residual stenosis is ≥50% following IVL, noncompliant balloon dilatation will be performed prior to stenting and OCT images repeated accordingly. Subsequent stent implantation will be performed per local standard of care at the discretion of the operator. Following stent implantation, high pressure post-dilatation is recommended and OCT imaging acquisition must be performed to assess stent apposition for secondary end point.

Study groups in NCT05973994
Study group	Role	What they receive
Patients with significant calcific coronary artery stenosis candidate to PCI		Patients with coronary artery calcifications responsible for significant stenosis will undergo basal OCT acquistion. After intravascular lithotripsy (IVL) application, a second OCT acquisition will be made. The mean calcium density of the vessel's ROI before IVL and after IVL will be compared. Stent implantation will be performed after the second OCT acquisition. Receives: Device: intravascular lithotripsy with Shockwave coronary system

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduction of calcium density in the Region of Interest (ROI) of the vessel after lithotripsy treatment
Calcium density is measured as delta pixel-density between calcific lesions images before and after lithotripsy at OCT acquisition
Measured: five-ten minutes

Secondary outcomes (2)

Reduction of stent malapposition after intracoronary lithotripsy application
Sten malapposition is measured as the distance between the abluminal surface of the strut and the luminal surface of the artery wall in the frames of lesion acquired by OCT after stent implantation.
Measured: five minutes after stent impantation
Incidence of acute vessel dissection and acute stent thrombosis or subacute vessel thrombosis after index procedure
Safety endpoint
Measured: one, six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Feb 202230 Jun 2025

First posted3 Aug 2023
Study start21 Feb 2022
Primary completion31 Dec 2024
Study completion30 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (76)Papers the sponsor has linked to this study.
Other trials for Coronary Artery CalcificationStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 20 participants (actual)
Target duration: 6 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT05973994
Sponsor's protocol ID: 75/21
Acronym: SCALPO
Status last verified: Nov 2026
First submitted: 25 Jul 2023
Last updated: 4 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Abdel-Wahab M, Richardt G, Joachim Buttner H, Toelg R, Geist V, Meinertz T, Schofer J, King L, Neumann FJ, Khattab AA. High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv. 2013 Jan;6(1):10-9. doi: 10.1016/j.jcin.2012.07.017. Epub 2012 Dec 19.
PubMed 23266232
Agarwal S, Cox AJ, Herrington DM, Jorgensen NW, Xu J, Freedman BI, Carr JJ, Bowden DW. Coronary calcium score predicts cardiovascular mortality in diabetes: diabetes heart study. Diabetes Care. 2013 Apr;36(4):972-7. doi: 10.2337/dc12-1548. Epub 2012 Dec 10.
PubMed 23230101
Ali ZA, Brinton TJ, Hill JM, Maehara A, Matsumura M, Karimi Galougahi K, Illindala U, Gotberg M, Whitbourn R, Van Mieghem N, Meredith IT, Di Mario C, Fajadet J. Optical Coherence Tomography Characterization of Coronary Lithoplasty for Treatment of Calcified Lesions: First Description. JACC Cardiovasc Imaging. 2017 Aug;10(8):897-906. doi: 10.1016/j.jcmg.2017.05.012.
PubMed 28797412
Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.
PubMed 31553205
Allison MA, Criqui MH, Wright CM. Patterns and risk factors for systemic calcified atherosclerosis. Arterioscler Thromb Vasc Biol. 2004 Feb;24(2):331-6. doi: 10.1161/01.ATV.0000110786.02097.0c. Epub 2003 Dec 4.
PubMed 14656730
Barbato E, Shlofmitz E, Milkas A, Shlofmitz R, Azzalini L, Colombo A. State of the art: evolving concepts in the treatment of heavily calcified and undilatable coronary stenoses - from debulking to plaque modification, a 40-year-long journey. EuroIntervention. 2017 Aug 25;13(6):696-705. doi: 10.4244/EIJ-D-17-00473.
PubMed 28844031
Baumbach A, Bittl JA, Fleck E, Geschwind HJ, Sanborn TA, Tcheng JE, Karsch KR. Acute complications of excimer laser coronary angioplasty: a detailed analysis of multicenter results. Coinvestigators of the U.S. and European Percutaneous Excimer Laser Coronary Angioplasty (PELCA) Registries. J Am Coll Cardiol. 1994 May;23(6):1305-13. doi: 10.1016/0735-1097(94)90371-9.
PubMed 8176087
Benezet J, Diaz de la Llera LS, Cubero JM, Villa M, Fernandez-Quero M, Sanchez-Gonzalez A. Drug-eluting stents following rotational atherectomy for heavily calcified coronary lesions: long-term clinical outcomes. J Invasive Cardiol. 2011 Jan;23(1):28-32.
PubMed 21183767
Bhatt P, Parikh P, Patel A, Chag M, Chandarana A, Parikh R, Parikh K. Long-term safety and performance of the orbital atherectomy system for treating calcified coronary artery lesions: 5-Year follow-up in the ORBIT I trial. Cardiovasc Revasc Med. 2015 Jun;16(4):213-6. doi: 10.1016/j.carrev.2015.03.007. Epub 2015 Mar 31.
PubMed 25866032
Bourantas CV, Zhang YJ, Garg S, Iqbal J, Valgimigli M, Windecker S, Mohr FW, Silber S, Vries Td, Onuma Y, Garcia-Garcia HM, Morel MA, Serruys PW. Prognostic implications of coronary calcification in patients with obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-level pooled analysis of 7 contemporary stent trials. Heart. 2014 Aug;100(15):1158-64. doi: 10.1136/heartjnl-2013-305180. Epub 2014 May 20.
PubMed 24846971
Brinton TJ, Ali ZA, Hill JM, Meredith IT, Maehara A, Illindala U, Lansky A, Gotberg M, Van Mieghem NM, Whitbourn R, Fajadet J, Di Mario C. Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses. Circulation. 2019 Feb 5;139(6):834-836. doi: 10.1161/CIRCULATIONAHA.118.036531. No abstract available.
PubMed 30715944
Brodmann M, Holden A, Zeller T. Safety and Feasibility of Intravascular Lithotripsy for Treatment of Below-the-Knee Arterial Stenoses. J Endovasc Ther. 2018 Aug;25(4):499-503. doi: 10.1177/1526602818783989. Epub 2018 Jun 18.
PubMed 29911480
Brodmann M, Werner M, Brinton TJ, Illindala U, Lansky A, Jaff MR, Holden A. Safety and Performance of Lithoplasty for Treatment of Calcified Peripheral Artery Lesions. J Am Coll Cardiol. 2017 Aug 15;70(7):908-910. doi: 10.1016/j.jacc.2017.06.022. No abstract available.
PubMed 28797363
Brodmann M, Werner M, Holden A, Tepe G, Scheinert D, Schwindt A, Wolf F, Jaff M, Lansky A, Zeller T. Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II. Catheter Cardiovasc Interv. 2019 Feb 1;93(2):335-342. doi: 10.1002/ccd.27943. Epub 2018 Nov 25.
PubMed 30474206
Budoff MJ, Young R, Burke G, Jeffrey Carr J, Detrano RC, Folsom AR, Kronmal R, Lima JAC, Liu KJ, McClelland RL, Michos E, Post WS, Shea S, Watson KE, Wong ND. Ten-year association of coronary artery calcium with atherosclerotic cardiovascular disease (ASCVD) events: the multi-ethnic study of atherosclerosis (MESA). Eur Heart J. 2018 Jul 1;39(25):2401-2408. doi: 10.1093/eurheartj/ehy217.
PubMed 29688297

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Calcification trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Shockwave Induced Attenuation of Calcified Plaques Quantified With OCT
ClinicalTrials.gov ID: NCT05973994
Acronym / sponsor ID: SCALPO / 75/21
Conditions: Coronary Artery Calcification
Keywords: Coronary artery calcification, Intravascular Lithotripsy, Optical Coherence Tomography, Calcium density
Study type: Observational
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University of Rome Tor VergataUniversity, hospital or other
Study start: 21 Feb 2022 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 30 Jun 2025 (actual)
First posted: 3 Aug 2023 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 6 Months
Number of arms: 1

Arm	Type	Receives
Patients with significant calcific coronary artery stenosis candidate to PCI	–	Device: intravascular lithotripsy with Shockwave coronary systemPatients with coronary artery calcifications responsible for significant stenosis will undergo basal OCT acquistion. After intravascular lithotripsy (IVL) application, a second OCT acquisition will be made. The mean calcium density of the vessel's ROI before IVL and after IVL will be compared. Stent implantation will be performed after the second OCT acquisition.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients in the Catheterization Laboratory that undergo coronary angiography, are potentially selected.

Key inclusion criteria (12 listed)

Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
Left ventricular ejection fraction (LVEF) ≥35% as measured prior to enrollment
eGFR ≥45 ml/min (Cockroft-Gault, MDRD)
Troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure or if troponin is elevated, concomitant CK must be normal
Ability to tolerate dual antiplatelet therapy (i.e. aspirin and clopidogrel, prasugrel, or ticagrelor) for at least 6 months (for patient not on oral anticoagulation) and single antiplatelet therapy for life

Key exclusion criteria (17 listed)

Left ventricular ejection fraction (LVEF) <35%
Subject is pregnant or nursing
eGFR <45 ml/min (Cockroft-Gault, MDRD) or chronic dialysis
Untreated pre-procedural haemoglobin <9 g/dL or intention to refuse blood transfusions if one should become necessary
Patient has a platelet count <100,000 cells/mm3 or >750,000 cells/mm3

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
intravascular lithotripsy with Shockwave coronary systemAlso: OCT acquisition with FD-OCT imaging catheterOCT acquistion is performed at baseline. Then the IVL catheter will be passed across the lesion over the guidewire. Atherectomy or cutting/scoring balloons is not permitted per protocol. The IVL procedure is considered successful when a residual stenosis <50% by visual estimate after IVL alone is achieved. After IVL procedure, one OCT imaging acquisition must be performed. If the residual stenosis is ≥50% following IVL, noncompliant balloon dilatation will be performed prior to stenting and OCT images repeated accordingly. Subsequent stent implantation will be performed per local standard of care at the discretion of the operator. Following stent implantation, high pressure post-dilatation is recommended and OCT imaging acquisition must be performed to assess stent apposition for secondary end point.	Device	Patients with significant calcific coronary artery stenosis candidate to PCI

Primary outcome

Reduction of calcium density in the Region of Interest (ROI) of the vessel after lithotripsy treatment
Time frame: five-ten minutes
Calcium density is measured as delta pixel-density between calcific lesions images before and after lithotripsy at OCT acquisition

2 secondary outcomes

Reduction of stent malapposition after intracoronary lithotripsy application
Time frame: five minutes after stent impantation
Incidence of acute vessel dissection and acute stent thrombosis or subacute vessel thrombosis after index procedure
Time frame: one, six months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
Background: PubMed 23266232Abdel-Wahab M, Richardt G, Joachim Buttner H, Toelg R, Geist V, Meinertz T, Schofer J, King L, Neumann FJ, Khattab AA. High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv. 2013 Jan;6(1):10-9. doi: 10.1016/j.jcin.2012.07.017. Epub 2012 Dec 19.
Background: PubMed 23230101Agarwal S, Cox AJ, Herrington DM, Jorgensen NW, Xu J, Freedman BI, Carr JJ, Bowden DW. Coronary calcium score predicts cardiovascular mortality in diabetes: diabetes heart study. Diabetes Care. 2013 Apr;36(4):972-7. doi: 10.2337/dc12-1548. Epub 2012 Dec 10.
Background: PubMed 28797412Ali ZA, Brinton TJ, Hill JM, Maehara A, Matsumura M, Karimi Galougahi K, Illindala U, Gotberg M, Whitbourn R, Van Mieghem N, Meredith IT, Di Mario C, Fajadet J. Optical Coherence Tomography Characterization of Coronary Lithoplasty for Treatment of Calcified Lesions: First Description. JACC Cardiovasc Imaging. 2017 Aug;10(8):897-906. doi: 10.1016/j.jcmg.2017.05.012.
Background: PubMed 31553205Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.
Background: PubMed 14656730Allison MA, Criqui MH, Wright CM. Patterns and risk factors for systemic calcified atherosclerosis. Arterioscler Thromb Vasc Biol. 2004 Feb;24(2):331-6. doi: 10.1161/01.ATV.0000110786.02097.0c. Epub 2003 Dec 4.
Background: PubMed 28844031Barbato E, Shlofmitz E, Milkas A, Shlofmitz R, Azzalini L, Colombo A. State of the art: evolving concepts in the treatment of heavily calcified and undilatable coronary stenoses - from debulking to plaque modification, a 40-year-long journey. EuroIntervention. 2017 Aug 25;13(6):696-705. doi: 10.4244/EIJ-D-17-00473.
Background: PubMed 8176087Baumbach A, Bittl JA, Fleck E, Geschwind HJ, Sanborn TA, Tcheng JE, Karsch KR. Acute complications of excimer laser coronary angioplasty: a detailed analysis of multicenter results. Coinvestigators of the U.S. and European Percutaneous Excimer Laser Coronary Angioplasty (PELCA) Registries. J Am Coll Cardiol. 1994 May;23(6):1305-13. doi: 10.1016/0735-1097(94)90371-9.
Background: PubMed 21183767Benezet J, Diaz de la Llera LS, Cubero JM, Villa M, Fernandez-Quero M, Sanchez-Gonzalez A. Drug-eluting stents following rotational atherectomy for heavily calcified coronary lesions: long-term clinical outcomes. J Invasive Cardiol. 2011 Jan;23(1):28-32.
Background: PubMed 25866032Bhatt P, Parikh P, Patel A, Chag M, Chandarana A, Parikh R, Parikh K. Long-term safety and performance of the orbital atherectomy system for treating calcified coronary artery lesions: 5-Year follow-up in the ORBIT I trial. Cardiovasc Revasc Med. 2015 Jun;16(4):213-6. doi: 10.1016/j.carrev.2015.03.007. Epub 2015 Mar 31.
Background: PubMed 24846971Bourantas CV, Zhang YJ, Garg S, Iqbal J, Valgimigli M, Windecker S, Mohr FW, Silber S, Vries Td, Onuma Y, Garcia-Garcia HM, Morel MA, Serruys PW. Prognostic implications of coronary calcification in patients with obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-level pooled analysis of 7 contemporary stent trials. Heart. 2014 Aug;100(15):1158-64. doi: 10.1136/heartjnl-2013-305180. Epub 2014 May 20.
Background: PubMed 30715944Brinton TJ, Ali ZA, Hill JM, Meredith IT, Maehara A, Illindala U, Lansky A, Gotberg M, Van Mieghem NM, Whitbourn R, Fajadet J, Di Mario C. Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses. Circulation. 2019 Feb 5;139(6):834-836. doi: 10.1161/CIRCULATIONAHA.118.036531. No abstract available.
Background: PubMed 29911480Brodmann M, Holden A, Zeller T. Safety and Feasibility of Intravascular Lithotripsy for Treatment of Below-the-Knee Arterial Stenoses. J Endovasc Ther. 2018 Aug;25(4):499-503. doi: 10.1177/1526602818783989. Epub 2018 Jun 18.

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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. This study is not recruiting at the moment.

Giuseppe M Sangiorgi, Professor principal investigator

University of Rome Tor Vergata

1 site 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 Calcification, run by University of Rome Tor Vergata at 1 site in Italy.

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 12 inclusion and 17 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: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of calcium density in the Region of Interest (ROI) of the vessel after lithotripsy treatment (time frame: five-ten minutes). 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 NCT05973994, which also lists 76 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 4 Nov 2026.