Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577038
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Prospective Registry on Intravascular Lithotripsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective International Multicenter All-comers Registry for the Study of Intravascular Lithotripsy in Coronary Interventions
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BENELUX-IVL
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 clinicalanatomical 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
1 To analyze the trends of IVL use overall and according to clinicalanatomical 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None