The Lower Silesia Shockwave Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorRegional Cardiology Center, The Copper Health Centre (MCZ),
About this trial
Lower Silesia Shockwave Registry (LSSR), is a observational registry collecting all consecutive cases of percutaneous coronary intervention (PCI) performed with the support of shockwave intravascular lithotripsy in two cooperating cardiac centers (Department of Cardiology, The Copper Health Centre, Lubin Poland, and Department of Cardiology, Provincial Specialized Hospital in Legnica, Poland).
Eligibility criteria
Qualifiers
The presence of moderately to severely calcified lesions.
The presence of significant under-expansion (greater than 20% of the diameter) of the previously implanted stent.
Initial failure of the lesion preparation with either the NC balloon catheter or the atherectomy device.
Disqualifiers
Lack of patient consent
Target vessel dissection type 3 or higher according to spontaneous coronary artery dissection (SCAD) classification
Target vessel perforation due to previous unsuccessful lesion preparation
Pregnancy
Trial design
Treatments tested in this trial
- PCI with support of Shockwave Intravascular Lithotripsy
Treatment groups
400 Participants
are divided into 1 treatment groupSponsors and collaborators
Regional Cardiology Center, The Copper Health Centre (MCZ),
Lead sponsor
Provincial Specialized Hospital in Legnica
Collaborator
Source ClinicalTrials.gov