The Lower Silesia Shockwave Registry (LSSR)

June 21, 2023 updated by: Adrian Włodarczak, Regional Cardiology Center, The Copper Health Centre (MCZ),

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Lower Silesia
      • Legnica, Lower Silesia, Poland, 59-220
        • Recruiting
        • Department of Cardiology, Provincial Specialized Hospital in Legnica,
        • Contact:
      • Lubin, Lower Silesia, Poland, 59-300
        • Recruiting
        • Department of Cardiology, The Copper Health Centre (MCZ)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Evaluation at the end of index hospitalization
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).
Evaluation at the end of index hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Cardiology Center, The Copper Health Centre (MCZ),

Collaborators

Provincial Specialized Hospital in Legnica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CopperHealthCentre

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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