Prospective Registry on Intravascular Lithotripsy

NCT ID: NCT06577038

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2029-05-01

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).

Conditions

Calcific Coronary Arteriosclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

PCI with use of IVL

Intervention Type: DEVICE

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

Interventions

PCI with use of IVL

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

Intervention Type: DEVICE

Other Intervention Names

Shockwave intravascular lithotripsy system

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shockwave Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

José M Montero Cabezas

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José M Montero Cabezas, MD PhD

Role: STUDY_CHAIR

Leiden University Medical Center

Ibtihal Al Amri, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Red Cross Hospital

Athens, , Greece

Amsterdam University Medical Center

Amsterdam, North Holland, Netherlands

Leiden University Medical Center

Leiden, South Holland, Netherlands

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Rijnstate Ziekenhuis

Arnhem, , Netherlands

Medisch Centrum Leeuwaarden

Leeuwarden, , Netherlands

Radboud University Medical Center

Nijmegen, , Netherlands

Countries

Belgium; Greece; Netherlands

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Other Identifiers

CardioLUMC

Identifier Type: -

Identifier Source: org_study_id