Prospective, International, Multicenter, All-comers Registry for the Study of Intravascular Lithotripsy in Coronary Interventions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Calcific Coronary Arteriosclerosis
- Sponsor
- Leiden University Medical Center
- Enrollment
- 1000
- Locations
- 8
- Primary Endpoint
- procedural success
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
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).
Investigators
José M Montero Cabezas
Principal investigator
Leiden University Medical Center
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.
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- rate of MACE at 6 months(At 6 months follow-up)
- rate of MACE at 3 months(At 3 months follow-up)
- rate of MACE at 12 months(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(at 12-months follow-up)