Prospective Registry on Intravascular Lithotripsy

Official title

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

Overview

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.

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).

Interventions

• Device PCI with use of IVL
  Use of IVL for the treatment of calcific coronary artery lesions at operator's discretion

Primary outcome measures

• procedural success [Time frame: Periprocedurally and from hospital admission to discharge (an average of 2 days)]
• cumulative hierarchical incidence of MACE [Time frame: At 30 days follow-up]

Secondary outcome measures (8)

• rate of MACE at 3 months [Time frame: At 3 months follow-up]
• rate of MACE at 6 months [Time frame: At 6 months follow-up]
• rate of MACE at 12 months [Time frame: At 12 months follow-up]
• 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 [Time frame: 30-days, 3-, 6- and 12-months]
• 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 [Time frame: at 30-days follow-up]
• 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 [Time frame: at 3 months follow-up]
• 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 [Time frame: at 6 months follow-up]
• 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 [Time frame: at 12-months follow-up]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

Netherlands · 6 centers

• Amsterdam University Medical Center — Amsterdam
• Leiden University Medical Center — Leiden
• Jeroen Bosch Ziekenhuis — 's-Hertogenbosch
• Rijnstate Ziekenhuis — Arnhem
• Medisch Centrum Leeuwaarden — Leeuwarden
• Radboud University Medical Center — Nijmegen

Belgium · 1 center

• Cliniques Universitaires Saint-Luc — Brussels

Greece · 1 center

• Red Cross Hospital — Athens

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) PMID 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-22-007 PMID 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. PMID 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. PMID 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. PMID 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. PMID 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 EURO4 PMID 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. PMID 33069849

Identifiers

NCT: NCT06577038 · CardioLUMC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗