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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Poland
Department of Cardiology, Provincial Specialized Hospital in Legnica,
RECRUITING
Legnica
Department of Cardiology, The Copper Health Centre (MCZ)
RECRUITING
Lubin
Contact Information
Primary
Adrian Włodarczak, M.D; Ph. D; Assoc Prof.
wlodarczak.adrian@gmail.com
+48768460300
Backup
Piotr Rola, M.D.; Ph.D.
piotr.rola@gmail.com
+48767211446
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 400
Treatments
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.
Sponsors
Leads: Regional Cardiology Center, The Copper Health Centre (MCZ),
Collaborators: Provincial Specialized Hospital in Legnica

This content was sourced from clinicaltrials.gov