| NCT ID | NCT05916898 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Regional Cardiology Center, The Copper Health Centre (MCZ), |
| Condition | Safety Issues |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2022-05-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05916898 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Safety Issues. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05916898 currently recruiting?
Yes, NCT05916898 is actively recruiting participants. Contact the research team at wlodarczak.adrian@gmail.com for enrollment information.
Where is the NCT05916898 trial being conducted?
This trial is being conducted at Legnica, Poland, Lubin, Poland.
Who is sponsoring the NCT05916898 clinical trial?
NCT05916898 is sponsored by Regional Cardiology Center, The Copper Health Centre (MCZ),. The trial plans to enroll 400 participants.