Prospective Registry on Intravascular Lithotripsy

Conditions

Calcific Coronary Arteriosclerosis

Keywords

calcific coronary lesions, intravascular lithotripsy, debulking, Complex percutaneous coronary interventions

Brief 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.

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).

Oliveri F, Van Oort MJH, Phagu A, Bingen BO, Paradies V, Mincione G, Claessen BE, Karalis I, Mouratidou M, Dimitriu-Leen AC, Sagris M, Kefer J, Vossenberg T, Mandurino-Mirizzi A, Van der Kley F, Jukema JW, Al Amri I, Montero-Cabezas J.

2026-07-15

10.1016/j.jacadv.2026.103010

Intravascular lithotripsy for the treatment of calcified coronary lesions in individuals of advanced age: a post-hoc analysis of the multicentre, prospective BENELUX-IVL study.

Oliveri F, García PV, van Oort MJH, Phagu A, Al Amri I, Bingen BO, Paradies V, Mincione G, Claessen BE, Dimitriu-Leen AC, Kefer J, Girgis H, Vossenberg T, Mandurino-Mirizzi A, Van der Kley F, Jukema JW, Montero-Cabezas JM.

2025-07-041 citations

10.1016/j.eclinm.2025.103342

Coronary Compliance Modification by Intravascular Lithotripsy: New Predictor of Stent Expansion in Calcified Coronary Lesions.

Oliveri F, Van Oort MJH, Al Amri I, Bingen BO, Claessen BE, Dimitriu-Leen AC, Kefer J, Girgis H, Vossenberg T, Van der Kley F, Jukema JW, Montero-Cabezas JM.

2025-05-012 citations

10.1016/j.jscai.2025.102635

Interventions

DEVICEPCI with use of IVL

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
procedural success	Periprocedurally and from hospital admission to discharge (an average of 2 days)	success in facilitating stent delivery with \<30% residual stenosis and without in-hospital MACE
cumulative hierarchical incidence of MACE	At 30 days follow-up	cardiac death, non-fatal target vessel myocardial infarction (MI), or clinically driven target lesion revascularization (TLR) at 30-days following the index procedure

Secondary

Measure	Time frame	Description
rate of MACE at 3 months	At 3 months follow-up	rate of MACE at 3-months following the index procedure
rate of MACE at 6 months	At 6 months follow-up	rate of MACE at 6-months following the index procedure
rate of MACE at 12 months	At 12 months follow-up	rate of MACE at 12-months following the index procedure
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	30-days, 3-, 6- and 12-months	at any time point, any type of angina at 30-days, 3-, 6- and 12-months following the index procedure

Countries

Belgium, Greece, Netherlands

Outcome results

None listed