The Lower Silesia Shockwave Registry

Safety Issues Clinical Trial

— LSSR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05916898
• Other study ID #: CopperHealthCentre
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: May 1, 2027

Study information

• Verified date: June 2023
• Source: Regional Cardiology Center, The Copper Health Centre (MCZ),
• Contact: Adrian Wlodarczak, M.D; Ph. D; Assoc Prof.
• Phone: +48768460300
• Email: wlodarczak.adrian[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Description:

This study contains data from the Lower Silesia Shockwave Registry (LSSR), collecting all consecutive cases of percutaneous coronary interventions (PCI) performed with the support of shockwave intravascular lithotripsy from two cooperating cardiac centers (Department of Cardiology, The Copper Health Centre, Lubin Poland, and Department of Cardiology, Provincial Specialized Hospital in Legnica, Poland).

All patients involved in the study had a clinical indication for PCI based on current European Society of Cardiology (ESC) revascularisation guidelines, if necessary with the support of the local heart team.

Patients enrolled in the study had to meet one of two main inclusion criteria: The presence of a highly calcified, resistant lesion or a significantly under-expanded, previously implanted stent (regardless of the time of implantation). The lesion was defined as resistant after an unsuccessful high-pressure non-compliant (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. Patients meeting the inclusion criteria who initially underwent advanced debulking procedures (orbital or rotational atherectomy) were also recruited.

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. Drug-eluting stent (DES) implantation or use of drug-eluting balloon catheters was left at the discretion of the operator.

The study had two primary endpoints- clinical success and safety outcome. The Clinical success was defined as an 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.

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). Also, adverse cardiac and cerebrovascular events (MACCE) were recorded. The MACCE consisted of death, myocardial infarction, acute cerebrovascular events, and repeated revascularization of the target lesion. Clinical follow-up was obtained by professional medical staff - personally or by telephone contacts periodically every 6 months after the index procedure. The study has the approval of a local ethics committee ( Bioethical Committee at the Lower Silesian Medical Chamber - number of approval 04/BOBD/2022).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Efficacy, Self
• Safety Issues

Intervention

Device:
• PCI 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

Country	Name	City	State
Poland	Department of Cardiology, Provincial Specialized Hospital in Legnica,	Legnica	Lower Silesia
Poland	Department of Cardiology, The Copper Health Centre (MCZ)	Lubin	Lower Silesia

Sponsors (2)

Lead Sponsor	Collaborator
Regional Cardiology Center, The Copper Health Centre (MCZ),	Provincial Specialized Hospital in Legnica

Country where clinical trial is conducted

Poland, 

References & 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 Registr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Major adverse cardiac and cerebrovascular events (MACCE)	The MACCE consisted of death, myocardial infarction, acute cerebrovascular events, and repeated revascularization of the target lesion.	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).