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The Lower Silesia Shockwave Registry (LSSR)

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ClinicalTrials.gov Identifier: NCT05916898
Recruitment Status : Recruiting
First Posted : June 23, 2023
Last Update Posted : June 23, 2023
Sponsor:
Collaborator:
Provincial Specialized Hospital in Legnica
Information provided by (Responsible Party):
Adrian Włodarczak, Regional Cardiology Center, The Copper Health Centre (MCZ),

Study Description
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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).

Condition or disease Intervention/treatment
Safety Issues Efficacy, Self Device: PCI with support of Shockwave Intravascular Lithotripsy

Detailed 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).

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Evaluation of the Safety and Efficiency of ShockWave Intravascular Lithotripsy (S-IVL) in Coronary Artery Diseases. The Lower Silesia Shockwave Registry (LSSR)
Actual Study Start Date : May 1, 2022
Estimated Primary Completion Date : May 1, 2026
Estimated Study Completion Date : May 1, 2027
Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Coronary artery angioplasty of the primary lesion or optimization of the previously implanted stent with the support of Shockwave Intravascular Lithotripsy device


Outcome Measures
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Primary Outcome Measures :
  1. The Clinical success [ Time Frame: Evaluation at the end of index hospitalization ]
    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.

  2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Evaluation at the end of index hospitalization ]
    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).


Secondary Outcome Measures :
  1. Major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: 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). ]
    The MACCE consisted of death, myocardial infarction, acute cerebrovascular events, and repeated revascularization of the target lesion.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All-commers population with CAD treated by PCI performed with the support of shockwave intravascular lithotripsy.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05916898


Contacts
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Contact: Adrian Włodarczak, M.D; Ph. D; Assoc Prof. +48768460300 wlodarczak.adrian@gmail.com
Contact: Piotr Rola, M.D.; Ph.D. +48767211446 piotr.rola@gmail.com

Locations
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Poland
Department of Cardiology, Provincial Specialized Hospital in Legnica, Recruiting
Legnica, Lower Silesia, Poland, 59-220
Contact: Piotr Rola, M.D; Ph.D.    +48767211446    piotr.rola@gmail.com   
Department of Cardiology, The Copper Health Centre (MCZ) Recruiting
Lubin, Lower Silesia, Poland, 59-300
Contact: Adrian Włodarczak, M.D; Ph.D.Assoc Prof.    +48768460300    wlodarczak.adrian@gmail.com   
Sponsors and Collaborators
Regional Cardiology Center, The Copper Health Centre (MCZ),
Provincial Specialized Hospital in Legnica
More Information
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Publications of Results:

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Responsible Party: Adrian Włodarczak, M.D.; Ph.D. Assoc Prof., Regional Cardiology Center, The Copper Health Centre (MCZ),
ClinicalTrials.gov Identifier: NCT05916898    
Other Study ID Numbers: CopperHealthCentre
First Posted: June 23, 2023    Key Record Dates
Last Update Posted: June 23, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Adrian Włodarczak, Regional Cardiology Center, The Copper Health Centre (MCZ),:
Percutaneous coronary interventions
Calcified Lesion
Shockwave intravascular lithotripsy
Stent under-expansion
 Coronary artery diseases
lesion preparation
stent optimalization
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases