Registry of heart artery procedures using shockwave lithotripsy

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults having a heart artery procedure (PCI) supported by shockwave intravascular lithotripsy, because the artery has hard calcium deposits or a stent that did not open fully.

Age

18 to 99 years

Sex

All sexes can join.

Disease stage

Moderately to severely calcified lesions in the heart arteries, or a previously placed stent that is not fully opened (more than 20% of the diameter under-expanded).

Earlier treatment

Preparing the lesion first with a balloon catheter (NC balloon) or an atherectomy device did not work initially. This applies to those whose lesion preparation failed.

Main reasons for not taking part

• No patient consent
• Tear in the wall of the target vessel (dissection type 3 or higher)
• Hole in the target vessel (perforation) after an earlier unsuccessful lesion preparation
• Pregnancy

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 99 years old?YesNo

What the trial wants to find out

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).

The group in the trial

• S-IVL Intervention

  Patients with the presence of a highly calcified, resistant lesion or a significantly under-expanded, previously implanted stent (regardless of the time of implantation) were part of the study cohort. The lesion was defined as resistant after an unsuccessful high-pressure NC balloon inflation (at least 20% under-expansion; whit at least 16 atm.). The decision regarding initial lesion preparation was left to the operators' dissertation and did not imply a recruitment process. There were no angiographic exclusion criteria regarding lesion anatomy regarding the length, tortuosity, severity, or prior stent placement. Operators supported by angiography assessment with optional intravascular imagining (IVUS/OCT) determined the size of the S-IVL catheter and an appropriate number of pulses for optimal vessel preparation or management of an under-expanded coronary stent.

  Treatment: PCI with support of Shockwave Intravascular Lithotripsy