Status:
ENROLLING_BY_INVITATION
Prospective Registry on Intravascular Lithotripsy
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Shockwave Medical, Inc.
Conditions:
Calcific Coronary Arteriosclerosis
Eligibility:
All Genders
18+ years
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 facilita...
Eligibility Criteria
Inclusion
- Age \>18 years-old
- Ability to provide written informed consent
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06577038
Start Date
May 1 2019
End Date
May 1 2029
Last Update
August 29 2024
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Cliniques Universitaires Saint-Luc
Brussels, Belgium
2
Red Cross Hospital
Athens, Greece
3
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands
4
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333ZA