Registry of patients undergoing coronary interventions with shockwave therapy
Evaluation of the Safety and Efficiency of ShockWave Intravascular Lithotripsy (S-IVL) in Coronary Artery Diseases. The Lower Silesia Shockwave Registry (LSSR)
This study is collecting information on patients with hard blockages in their heart arteries who are getting a new shockwave treatment to see how safe and effective it is.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Regional Cardiology Center, The Copper Health Centre (MCZ), Academic / other |
| Locations | 2 sites (Legnica, Lower Silesian Voivodeship and 1 other locations) |
| Trial ID | NCT05916898 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with moderately to severely calcified lesions or significant under-expansion of previously implanted stents.
Not a fit: Patients who lack consent, have severe vessel dissection, or are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding of shockwave therapy's effectiveness in treating complex coronary artery conditions.
How similar studies have performed: While the use of shockwave therapy in coronary interventions is emerging, this registry approach is relatively novel and aims to gather comprehensive data on its application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Legnica, Lower Silesian Voivodeship and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.