Prospective Registry on Intravascular Lithotripsy (BENELUX-IVL)

Leiden University Medical Center (LUMC)

Status: Invitation-only

Conditions: Calcific Coronary Arteriosclerosis

Treatments: Device: PCI with use of IVL

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06577038

CardioLUMC

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

IVL cohort

Description:

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, etc) and/or concomitant use of other debulking techniques

Treatment:

Device: PCI with use of IVL