Safety IssuesLSSRNCT05916898
The Lower Silesia Shockwave Registry
An observational study of Safety Issues and Efficacy, Self, run by Miedziowe Centrum Zdrowia SA at 2 sites in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Safety Issues, Efficacy, Self
- What is being tested?
- PCI with support of Shockwave Intravascular Lithotripsy
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 2 sitesPoland
- Study dates
- 1 May 2022to 1 May 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All-commers population with CAD treated by PCI performed with the support of shockwave intravascular lithotripsy.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Department of Cardiology, Provincial Specialized Hospital in Legnica,
Legnica, Lower Silesian Voivodeship, 59-220
Piotr Rola, M.D; Ph.D., +48767211446, piotr.rola@gmail.com
- Recruiting
Department of Cardiology, The Copper Health Centre (MCZ)
Lubin, Lower Silesian Voivodeship, 59-300
Adrian Włodarczak, M.D; Ph.D.Assoc Prof., +48768460300, wlodarczak.adrian@gmail.com
About this study
Official title: 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).
Read the 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).
- Conditions
- Safety Issues, Efficacy, Self
- Being tested
- PCI with support of Shockwave Intravascular Lithotripsy
- Keywords
- Percutaneous coronary interventions, Calcified Lesion, Shockwave intravascular lithotripsy, Stent under-expansion, Coronary artery diseases, lesion preparation, stent optimalization
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI with support of Shockwave Intravascular LithotripsyDevice
Coronary artery angioplasty of the primary lesion or optimization of the previously implanted stent with the support of Shockwave Intravascular Lithotripsy device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PCI with support of Shockwave Intravascular Lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Evaluation at the end of index hospitalization
Secondary outcomes (1)
Major adverse cardiac and cerebrovascular events (MACCE)
The MACCE consisted of death, myocardial infarction, acute cerebrovascular events, and repeated revascularization of the target lesion.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 May 2022
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Miedziowe Centrum Zdrowia SA
- Sponsor type
- University, hospital or other
- Collaborators
- Provincial Specialized Hospital in Legnica
- Responsible party
- Principal investigator, Adrian Włodarczak, Miedziowe Centrum Zdrowia SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916898
- Sponsor's protocol ID
- CopperHealthCentre
- Acronym
- LSSR
- Status last verified
- Jun 2023
- First submitted
- 25 May 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 34415567
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficiency of ShockWave Intravascular Lithotripsy (S-IVL) in Coronary Artery Diseases. The Lower Silesia Shockwave Registry (LSSR)
- ClinicalTrials.gov ID
- NCT05916898
- Acronym / sponsor ID
- LSSR / CopperHealthCentre
- Conditions
- Safety Issues, Efficacy, Self
- Keywords
- Percutaneous coronary interventions, Calcified Lesion, Shockwave intravascular lithotripsy, Stent under-expansion, Coronary artery diseases, lesion preparation, stent optimalization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Miedziowe Centrum Zdrowia SAUniversity, hospital or other
- Collaborators
- Provincial Specialized Hospital in Legnica
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-IVL Intervention | – | Device: PCI with support of Shockwave Intravascular LithotripsyPatients 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-commers population with CAD treated by PCI performed with the support of shockwave intravascular lithotripsy.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCI with support of Shockwave Intravascular LithotripsyCoronary artery angioplasty of the primary lesion or optimization of the previously implanted stent with the support of Shockwave Intravascular Lithotripsy device | Device | S-IVL Intervention |
Primary outcome
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.
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).
1 secondary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Results publication: PubMed 34415567Rola 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety Issues and Efficacy, Self, run by Miedziowe Centrum Zdrowia SA at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrian Włodarczak, M.D; Ph. D; Assoc Prof. (+48768460300, wlodarczak.adrian@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Clinical success (time frame: Evaluation at the end of index hospitalization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05916898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.