Prospective Registry on Intravascular Lithotripsy

Last updated: August 27, 2024
Sponsor: Leiden University Medical Center
Overall Status: Active - Enrolling

Phase

N/A

Condition

Occlusions

Vascular Diseases

Coronary Artery Disease

Treatment

PCI with use of IVL

Clinical Study ID

NCT06577038
CardioLUMC
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >18 years-old

  • Ability to provide written informed consent

Exclusion

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 vulnerablepopulation , 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. Vulnerablepopulations also may include members of a group with a hierarchical structure suchas university students, subordinate hospital and laboratory personnel, employees ofthe Sponsor, members of the armed forces, and persons kept in detention.

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: PCI with use of IVL
Phase:
Study Start date:
May 01, 2019
Estimated Completion Date:
May 01, 2029

Study 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).

Connect with a study center

  • Cliniques Universitaires Saint-Luc

    Brussel,
    Belgium

    Site Not Available

  • Red Cross Hospital

    Athens,
    Greece

    Site Not Available

  • Amsterdam University Medical Center

    Amsterdam, Noord Holland
    Netherlands

    Site Not Available

  • Leiden University Medical Center

    Leiden, Zuid Holland 2333ZA
    Netherlands

    Site Not Available

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch,
    Netherlands

    Site Not Available

  • Rijnstate Ziekenhuis

    Arnhem,
    Netherlands

    Site Not Available

  • Medisch Centrum Leeuwaarden

    Leeuwarden,
    Netherlands

    Site Not Available

  • Radboud University Medical Center

    Nijmegen,
    Netherlands

    Site Not Available

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