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Enrolling by Invitation

NCT Number: NCT06577038

Prospective Registry on Intravascular Lithotripsy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques Universitaires Saint-Luc, Brussels, Belgium

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About this study

The primary objectives are:

  • To analyze the trends of IVL use overall and according to clinical/anatomical indications
  • To evaluate the rates of procedural success, defined as success in facilitating stent delivery with <30% residual stenosis and without in-hospital
  • 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:

  • To describe the rate of MACE at 3-, 6- and 12-months following the index procedure
  • 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
  • To describe the rates of target lesion failure (TLF) (see end-points definitions section)
  • To describe the rates of device crossing success (see end-points definitions section)
  • To describe the rates of serious angiographic complications (see end-points definitions section)
  • To assess predictors of clinical outcomes based on patient and procedural characteristics
  • To analyze current standards of practice regarding IVL technology in a real-world multinational cohort (technique, training, local protocols).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PCI with use of IVL

Device

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

Other names: Shockwave intravascular lithotripsy system

Primary outcomes

  1. procedural success

    Time frame: 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

  2. cumulative hierarchical incidence of MACE

    Time frame: 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 outcomes

  1. rate of MACE at 3 months

    Time frame: At 3 months follow-up

    rate of MACE at 3-months following the index procedure

  2. rate of MACE at 6 months

    Time frame: At 6 months follow-up

    rate of MACE at 6-months following the index procedure

  3. rate of MACE at 12 months

    Time frame: At 12 months follow-up

    rate of MACE at 12-months following the index procedure

  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

    Time frame: 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

  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

    Time frame: at 30-days follow-up

    at any time point, any type of angina 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

    Time frame: at 3 months follow-up

    at any time point, any type of angina 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

    Time frame: at 6 months follow-up

    at any time point, any type of angina 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

    Time frame: at 12-months follow-up

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

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Shockwave Medical, Inc.

Registry information

Official study title

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

Acronym: BENELUX-IVL

Important dates

Study start
2019
Primary completion
2024
Study completion
2029
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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