Prospective Registry on Intravascular Lithotripsy (BENELUX-IVL)

August 27, 2024 updated by: José M Montero Cabezas, Leiden University Medical Center

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium
        • Cliniques Universitaires Saint-Luc
  • Greece
      • Athens, Greece
        • Red Cross Hospital
  • Netherlands
      • 's-Hertogenbosch, Netherlands
        • Jeroen Bosch Ziekenhuis
      • Arnhem, Netherlands
        • Rijnstate Ziekenhuis
      • Leeuwarden, Netherlands
        • Medisch Centrum Leeuwaarden
      • Nijmegen, Netherlands
        • Radboud University Medical Center
    • Noord Holland
      • Amsterdam, Noord Holland, Netherlands
        • Amsterdam University Medical Center
    • Zuid Holland
      • Leiden, Zuid Holland, Netherlands, 2333ZA
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of 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 due to poorly stent expansion) and/or concomitant use of other debulking techniques (e.g. RA).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IVL cohort
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
Device: PCI with use of IVL
Use of IVL for the treatment of calcific coronary artery lesions at operator's discretion
Other Names:
  • Shockwave intravascular lithotripsy system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Periprocedurally and from hospital admission to discharge (an average of 2 days)
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
At 30 days follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Collaborators

Shockwave Medical, Inc.

Investigators

  • Study Chair: José M Montero Cabezas, MD PhD, Leiden University Medical Center
  • Principal Investigator: Ibtihal Al Amri, MD PhD, Leiden University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

February 1, 2024

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CardioLUMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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