No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 – 99
Sex
Any
Study type
Observational
Participants needed
400 (estimated)
Sponsor
Regional Cardiology Center, The Copper Health Centre (MCZ), · Other
Who this trial is looking for
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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).
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* 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 devi…
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
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