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The Lower Silesia Shockwave Registry

ConditionsSafety IssuesEfficacy, Self
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorRegional Cardiology Center, The Copper Health Centre (MCZ),

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: S-IVL Intervention1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Evaluation at the end of index hospitalization
2

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).

Time frame
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.

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).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Provincial Specialized Hospital in Legnica

Collaborator

Source ClinicalTrials.gov
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