NCT06577038

Prospective Registry on Intravascular Lithotripsy

Prospective, International, Multicenter, All-comers Registry for the Study of Intravascular Lithotripsy in Coronary Interventions

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
DEVICE	PCI with use of IVL	Use of IVL for the treatment of calcific coronary artery lesions at operator's discretion

Timeline

• Start date: 2019-05-01
• Primary completion: 2024-02-01
• Completion: 2029-05-01
• First posted: 2024-08-29
• Last updated: 2024-08-29

Locations

8 sites across 3 countries: Belgium, Greece, Netherlands

Regulatory

• FDA-regulated device study