Clinical trial NCT06577038: Prospective Registry on Intravascular Lithotripsy
Official title: Prospective, International, Multicenter, All-comers Registry for the Study of Intravascular Lithotripsy in Coronary Interventions
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Calcific Coronary Arteriosclerosis
Keywords: calcific coronary lesions
intravascular lithotripsy
debulking
Complex percutaneous coronary interventions
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Shockwave Medical, Inc.
First posted: 2024-08-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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).

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.

Primary outcomes:
measure: procedural success
timeFrame: Periprocedurally and from hospital admission to discharge (an average of 2 days)
measure: cumulative hierarchical incidence of MACE
timeFrame: At 30 days follow-up
Secondary outcomes:
measure: rate of MACE at 3 months
timeFrame: At 3 months follow-up
measure: rate of MACE at 6 months
timeFrame: At 6 months follow-up
measure: rate of MACE at 12 months
timeFrame: At 12 months follow-up
measure: 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
timeFrame: 30-days, 3-, 6- and 12-months
measure: 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
timeFrame: at 30-days follow-up
measure: 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
timeFrame: at 3 months follow-up
measure: 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
timeFrame: at 6 months follow-up
measure: 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
timeFrame: at 12-months follow-up
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Athens
country: Greece
facility: Red Cross Hospital
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
state: Noord Holland
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid Holland
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwaarden
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
Study officials:
affiliation: Leiden University Medical Center
name: José M Montero Cabezas, MD PhD
role: STUDY_CHAIR
affiliation: Leiden University Medical Center
name: Ibtihal Al Amri, MD PhD
role: PRINCIPAL_INVESTIGATOR
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