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Calcific Coronary ArteriosclerosisBENELUX-IVLNCT06577038

Prospective Registry on Intravascular Lithotripsy

An observational study of Calcific Coronary Arteriosclerosis, run by Leiden University Medical Center at 8 sites in 3 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

multicenter, international, all-comers registry aims to provide insights in the current application of IVL technology in patients with calcified coronary lesions undergoing PCI using IVL technology. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Calcific Coronary Arteriosclerosis
What is being tested?
PCI with use of IVL
Type of treatment
Medical device
How many people
1,000 participants
Where
8 sitesin 3 countries
Study dates
1 May 2019to 1 May 2029
How long will I take part?
5 Years
Phase
Observational
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
  • Adult, Older adult

Study population: The study population will consist of patients with calcific CAD undergoing PCI and treated with IVL, irrespectively of the clinical indication (stable angina, acute coronary syndrome), anatomical scenario (de novo coronary stenosis, in-stent restenosis due to poorly stent expansion) and/or concomitant use of other debulking techniques (e.g. RA).

Who may be able to join

  • Age >18 years-old
  • Ability to provide written informed consent

Who cannot join

  • Patient has any comorbidity or condition that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent
  • Patient belongs to a vulnerable population Subject is a member of a vulnerable population , including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Trial locations and contacts

8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

8 sites in 3 countries

Netherlands6 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

  • Amsterdam University Medical Center

    Amsterdam, North Holland

  • Rijnstate Ziekenhuis

    Arnhem

  • Medisch Centrum Leeuwaarden

    Leeuwarden

  • Leiden University Medical Center

    Leiden, South Holland, 2333ZA

  • Radboud University Medical Center

    Nijmegen

Other trials in Netherlands

Belgium1 site

  • Cliniques Universitaires Saint-Luc

    Brussels

Other trials in Belgium

Greece1 site

  • Red Cross Hospital

    Athens

Other trials in Greece

About this study

Official title: Prospective, International, Multicenter, All-comers Registry for the Study of Intravascular Lithotripsy in Coronary Interventions

multicenter, international, all-comers registry aims to provide insights in the current application of IVL technology in patients with calcified coronary lesions undergoing PCI using IVL technology.

Read the detailed description

The primary objectives are:

  1. To analyze the trends of IVL use overall and according to clinical/anatomical indications
  2. To evaluate the rates of procedural success, defined as success in facilitating stent delivery with <30% residual stenosis and without in-hospital
  3. To describe the cumulative hierarchical incidence of MACE defined as: cardiac death, non-fatal target vessel myocardial infarction (MI), or clinically driven target lesion revascularization (TLR) at 30-days following the index procedure

The secondary objectives are:

  1. To describe the rate of MACE at 3-, 6- and 12-months following the index procedure
  2. To assess the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis at any time point, any type of angina at 30-days, 3-, 6- and 12-months following the index procedure
  3. To describe the rates of target lesion failure (TLF) (see end-points definitions section)
  4. To describe the rates of device crossing success (see end-points definitions section)
  5. To describe the rates of serious angiographic complications (see end-points definitions section)
  6. To assess predictors of clinical outcomes based on patient and procedural characteristics
  7. To analyze current standards of practice regarding IVL technology in a real-world multinational cohort (technique, training, local protocols).
Being tested
PCI with use of IVL
Keywords
calcific coronary lesions, intravascular lithotripsy, debulking, Complex percutaneous coronary interventions

What participants receive

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

  • PCI with use of IVLDevice

    Also called Shockwave intravascular lithotripsy system

    Use of IVL for the treatment of calcific coronary artery lesions at operator's discretion

Study groups in NCT06577038
Study groupRoleWhat they receive
IVL cohortPatients with calcific CAD undergoing PCI and treated with IVL, irrespectively of the clinical indication (stable angina, acute coronary syndrome), anatomical scenario (de novo coronary stenosis, in-stent restenosis, etc) and/or concomitant use of other debulking techniques
Receives: Device: PCI with use of IVL

What is being measured

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

  1. procedural success

    success in facilitating stent delivery with <30% residual stenosis and without in-hospital MACE

    Measured: Periprocedurally and from hospital admission to discharge (an average of 2 days)

  2. cumulative hierarchical incidence of MACE

    cardiac death, non-fatal target vessel myocardial infarction (MI), or clinically driven target lesion revascularization (TLR) at 30-days following the index procedure

    Measured: At 30 days follow-up

Secondary outcomes (8)

  1. rate of MACE at 3 months

    rate of MACE at 3-months following the index procedure

    Measured: At 3 months follow-up

  2. rate of MACE at 6 months

    rate of MACE at 6-months following the index procedure

    Measured: At 6 months follow-up

  3. rate of MACE at 12 months

    rate of MACE at 12-months following the index procedure

    Measured: At 12 months follow-up

  4. the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis

    at any time point, any type of angina at 30-days, 3-, 6- and 12-months following the index procedure

    Measured: 30-days, 3-, 6- and 12-months

  5. the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis

    at any time point, any type of angina at 30-days follow-up

    Measured: at 30-days follow-up

  6. the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis

    at any time point, any type of angina at 3 months follow-up

    Measured: at 3 months follow-up

  7. the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis

    at any time point, any type of angina at 6 months follow-up

    Measured: at 6 months follow-up

  8. the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis

    at any time point, any type of angina at 12-months follow-up

    Measured: at 12-months follow-up

Timeline

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

  1. First posted29 Aug 2024
  2. Study start1 May 2019
  3. Primary completion1 Feb 2024
  4. Study completion1 May 2029 (estimated)

Resources

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
1,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06577038
Sponsor's protocol ID
CardioLUMC
Acronym
BENELUX-IVL
Status last verified
Aug 2024
First submitted
22 Jul 2024
Last updated
29 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Kawashima H, Serruys PW, Hara H, Ono M, Gao C, Wang R, Garg S, Sharif F, de Winter RJ, Mack MJ, Holmes DR, Morice MC, Kappetein AP, Thuijs DJFM, Milojevic M, Noack T, Mohr FW, Davierwala PM, Onuma Y; SYNTAX Extended Survival Investigators. 10-Year All-Cause Mortality Following Percutaneous or Surgical Revascularization in Patients With Heavy Calcification. JACC Cardiovasc Interv. 2022 Jan 24;15(2):193-204. doi: 10.1016/j.jcin.2021.10.026. Epub 2021 Dec 29.

    PubMed 34973904

  • Rheude T, Koch T, Joner M, Lenz T, Xhepa E, Wiebe J, Coughlan JJ, Aytekin A, Cassese S, Laugwitz KL, Schunkert H, Kastrati A, Kufner S. Ten-year clinical outcomes of drug-eluting stents with different polymer coating strategies by degree of coronary calcification: a pooled analysis of the ISAR-TEST 4 and 5 randomised trials. EuroIntervention. 2023 Feb 20;18(14):1188-1196. doi: 10.4244/EIJ-D-22-00781.

    PubMed 36453826

  • Lee MS, Shah N. The Impact and Pathophysiologic Consequences of Coronary Artery Calcium Deposition in Percutaneous Coronary Interventions. J Invasive Cardiol. 2016 Apr;28(4):160-7. Epub 2015 Aug 25.

    PubMed 26301561

  • Madhavan MV, Tarigopula M, Mintz GS, Maehara A, Stone GW, Genereux P. Coronary artery calcification: pathogenesis and prognostic implications. J Am Coll Cardiol. 2014 May 6;63(17):1703-14. doi: 10.1016/j.jacc.2014.01.017. Epub 2014 Feb 12.

    PubMed 24530667

  • Mintz GS. Intravascular imaging of coronary calcification and its clinical implications. JACC Cardiovasc Imaging. 2015 Apr;8(4):461-471. doi: 10.1016/j.jcmg.2015.02.003.

    PubMed 25882575

  • Kassimis G, Raina T, Kontogiannis N, Patri G, Abramik J, Zaphiriou A, Banning AP. How Should We Treat Heavily Calcified Coronary Artery Disease in Contemporary Practice? From Atherectomy to Intravascular Lithotripsy. Cardiovasc Revasc Med. 2019 Dec;20(12):1172-1183. doi: 10.1016/j.carrev.2019.01.010. Epub 2019 Jan 10.

    PubMed 30711477

  • Barbato E, Gallinoro E, Abdel-Wahab M, Andreini D, Carrie D, Di Mario C, Dudek D, Escaned J, Fajadet J, Guagliumi G, Hill J, McEntegart M, Mashayekhi K, Mezilis N, Onuma Y, Reczuch K, Shlofmitz R, Stefanini G, Tarantini G, Toth GG, Vaquerizo B, Wijns W, Ribichini FL. Management strategies for heavily calcified coronary stenoses: an EAPCI clinical consensus statement in collaboration with the EURO4C-PCR group. Eur Heart J. 2023 Nov 1;44(41):4340-4356. doi: 10.1093/eurheartj/ehad342.

    PubMed 37208199

  • Hill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. J Am Coll Cardiol. 2020 Dec 1;76(22):2635-2646. doi: 10.1016/j.jacc.2020.09.603. Epub 2020 Oct 15.

    PubMed 33069849

  • Forero MNT, Daemen J. The Coronary Intravascular Lithotripsy System. Interv Cardiol. 2019 Nov 18;14(3):174-181. doi: 10.15420/icr.2019.18.R1. eCollection 2019 Nov.

    PubMed 31867065

  • Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3.

    PubMed 33939604

  • 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

  • Sianos G, Morel MA, Kappetein AP, Morice MC, Colombo A, Dawkins K, van den Brand M, Van Dyck N, Russell ME, Mohr FW, Serruys PW. The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease. EuroIntervention. 2005 Aug;1(2):219-27. No abstract available.

    PubMed 19758907

  • Mintz GS, Popma JJ, Pichard AD, Kent KM, Satler LF, Chuang YC, Ditrano CJ, Leon MB. Patterns of calcification in coronary artery disease. A statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation. 1995 Apr 1;91(7):1959-65. doi: 10.1161/01.cir.91.7.1959.

    PubMed 7895353

  • Tearney GJ, Regar E, Akasaka T, Adriaenssens T, Barlis P, Bezerra HG, Bouma B, Bruining N, Cho JM, Chowdhary S, Costa MA, de Silva R, Dijkstra J, Di Mario C, Dudek D, Falk E, Feldman MD, Fitzgerald P, Garcia-Garcia HM, Gonzalo N, Granada JF, Guagliumi G, Holm NR, Honda Y, Ikeno F, Kawasaki M, Kochman J, Koltowski L, Kubo T, Kume T, Kyono H, Lam CC, Lamouche G, Lee DP, Leon MB, Maehara A, Manfrini O, Mintz GS, Mizuno K, Morel MA, Nadkarni S, Okura H, Otake H, Pietrasik A, Prati F, Raber L, Radu MD, Rieber J, Riga M, Rollins A, Rosenberg M, Sirbu V, Serruys PW, Shimada K, Shinke T, Shite J, Siegel E, Sonoda S, Suter M, Takarada S, Tanaka A, Terashima M, Thim T, Uemura S, Ughi GJ, van Beusekom HM, van der Steen AF, van Es GA, van Soest G, Virmani R, Waxman S, Weissman NJ, Weisz G; International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT). Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. J Am Coll Cardiol. 2012 Mar 20;59(12):1058-72. doi: 10.1016/j.jacc.2011.09.079.

    PubMed 22421299

  • Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.

    PubMed 31504439

Questions about this trial

What is this clinical trial studying?

An observational study of Calcific Coronary Arteriosclerosis, run by Leiden University Medical Center at 8 sites in 3 countries.

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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Netherlands, Belgium, Greece. 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?

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?

procedural success (time frame: Periprocedurally and from hospital admission to discharge (an average of 2 days)). 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 NCT06577038, which also lists 24 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 29 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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