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NCT05916898Recruiting

The Lower Silesia Shockwave Registry

Evaluation of the Safety and Efficiency of ShockWave Intravascular Lithotripsy (S-IVL) in Coronary Artery Diseases. The Lower Silesia Shockwave Registry (LSSR)

Source: ClinicalTrials.gov · Last updated 23 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
25 May 2023
Start date
May 2022
Primary completion date
May 2026
Lead sponsor
Miedziowe Centrum Zdrowia SA
NCT number
NCT05916898

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From May 2022 to the primary completion date, May 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Target vessel perforation due to previous unsuccessful lesion preparation

Other

  • Lack of patient consent
  • Target vessel dissection type 3 or higher according to spontaneous coronary artery dissection (SCAD) classification
  • Pregnancy

Who the study is looking for

  • 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.

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Cardiology, Provincial Specialized Hospital in Legnica
Coordinator of this site? Confirm its status
LegnicaPolandRecruiting
Department of Cardiology, The Copper Health Centre (MCZ)
Coordinator of this site? Confirm its status
LubinPolandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.