The Lower Silesia Shockwave Registry

NCT05916898 | Recruiting FDA Device

• 1 other identifier: CopperHealthCentre
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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).

Conditions

Safety Issues; Efficacy, Self

Keywords

Percutaneous coronary interventions; Calcified Lesion; Shockwave intravascular lithotripsy; Stent under-expansion; Coronary artery diseases; lesion preparation; stent optimalization

Outcome Measures

Primary Outcomes (2)

• The Clinical success

  Effective stent deployment or the optimization of previously not fully expanded stent (with less than \<20% in-stent residual stenosis) and the presence of Thrombolysis in Myocardial Infarction (TIMI) 3 flow at the end of the procedure.

  Evaluation at the end of index hospitalization

• Incidence of Treatment-Emergent Adverse Events

  Safety outcomes were defined as procedural final serious angiographic complications procedural (perforation, abrupt closure, slow flow or no-reflow, unstable ventricular arrhythmias) and device failure (inability to cross the lesion, malfunction, or rapture).

  Evaluation at the end of index hospitalization

Secondary Outcomes (1)

• Major adverse cardiac and cerebrovascular events (MACCE)

  Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years).

Study Arms (1)

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.

Device: PCI with support of Shockwave Intravascular Lithotripsy

Interventions

PCI with support of Shockwave Intravascular Lithotripsy DEVICE

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

S-IVL Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All-commers population with CAD treated by PCI performed with the support of shockwave intravascular lithotripsy.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Regional Cardiology Center, The Copper Health Centre (MCZ),: lead
• Provincial Specialized Hospital in Legnica: collaborator

Study Sites (2)

Department of Cardiology, Provincial Specialized Hospital in Legnica,

Legnica, Lower Silesian Voivodeship, 59-220, Poland

RECRUITING

Department of Cardiology, The Copper Health Centre (MCZ)

Lubin, Lower Silesian Voivodeship, 59-300, Poland

RECRUITING

Related Publications (1)

• Rola P, Wlodarczak A, Kulczycki JJ, Barycki M, Furtan L, Szudrowicz M, Jastrzebski A, Pecherzewski M, Doroszko A, Lesiak M. Feasibility of the intravascular lithotripsy in coronary artery disease. Short-term outcomes of the Lower-Silesia Shockwave Registry. Kardiol Pol. 2021;79(10):1133-1135. doi: 10.33963/KP.a2021.0093. Epub 2021 Aug 20. No abstract available.

  PMID: 34415567 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Adrian Włodarczak, M.D; Ph. D; Assoc Prof.

CONTACT

+48768460300; wlodarczak.adrian@gmail.com

Piotr Rola, M.D.; Ph.D.

CONTACT

+48767211446; piotr.rola@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.; Ph.D. Assoc Prof.

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 23, 2023
• Study Start: May 1, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 23, 2023

Record last verified: 2023-06

Locations

PL (2)