Registry of patients undergoing coronary interventions with shockwave therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Lower Silesia Shockwave Registry collects data on consecutive cases of percutaneous coronary interventions (PCI) that utilize shockwave intravascular lithotripsy across two cardiac centers in Poland. Patients included in the registry have either highly calcified lesions or significantly under-expanded stents, and the study aims to evaluate the safety and efficacy of this innovative approach. The decision-making process for lesion preparation is left to the operators, allowing for flexibility in treatment strategies. This observational registry will provide valuable insights into the outcomes of these procedures in real-world settings.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Cardiology, Provincial Specialized Hospital in Legnica,
  Legnica, Lower Silesian Voivodeship, Poland Recruiting
• Department of Cardiology, The Copper Health Centre (MCZ)
  Lubin, Lower Silesian Voivodeship, Poland Recruiting

Study contacts

• Study coordinator: Adrian Włodarczak, M.D; Ph. D; Assoc Prof.
• Email: wlodarczak.adrian@gmail.com
• Phone: +48768460300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.