Prospective Registry on Intravascular Lithotripsy

• Conditions: Calcific Coronary Arteriosclerosis
• Interventions: Device: PCI with use of IVL

• Registration Number: NCT06577038
• Lead Sponsor: Leiden University Medical Center

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).

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2024-02-01
• Study First Submitted: 2024-07-22
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29
• Study Completion: 2029-05-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Age >18 years-old
• Ability to provide written informed consent

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IVL cohort	PCI with use of IVL	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

Primary Outcome Measures

Name	Time	Method
procedural success	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
cumulative hierarchical incidence of MACE	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 Outcome Measures

Name	Time	Method
rate of MACE at 6 months	At 6 months follow-up	rate of MACE at 6-months following the index procedure
rate of MACE at 3 months	At 3 months follow-up	rate of MACE at 3-months following the index procedure
rate of MACE at 12 months	At 12 months follow-up	rate of MACE at 12-months following the index procedure
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 12-months follow-up	at any time point, any type of angina at 12-months follow-up

Trial Locations

Locations (8)

Medisch Centrum Leeuwaarden; 🇳🇱 Leeuwarden, Netherlands

Red Cross Hospital; 🇬🇷 Athens, Greece

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussel, Belgium

Amsterdam University Medical Center; 🇳🇱 Amsterdam, Noord Holland, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Zuid Holland, Netherlands

Rijnstate Ziekenhuis; 🇳🇱 Arnhem, Netherlands

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands

Jeroen Bosch Ziekenhuis; 🇳🇱 's-Hertogenbosch, Netherlands