RecruitingNCT05916898

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)


Sponsor

Regional Cardiology Center, The Copper Health Centre (MCZ),

Enrollment

400 participants

Start Date

May 1, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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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Interventions

DEVICEPCI with support of Shockwave Intravascular Lithotripsy

Coronary artery angioplasty of the primary lesion or optimization of the previously implanted stent with the support of Shockwave Intravascular Lithotripsy device


Locations(2)

Department of Cardiology, Provincial Specialized Hospital in Legnica,

Legnica, Lower Silesian Voivodeship, Poland

Department of Cardiology, The Copper Health Centre (MCZ)

Lubin, Lower Silesian Voivodeship, Poland

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NCT05916898


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