An interventional study of Intravascular lithotripsy and Standard lesion preparation in Peripheral Arterial Disease, sponsored by University of Leipzig. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by University of Leipzig · Not applicable, Interventional, and Treatment
This study is an investigator-initiated, prospective, single-center, 1:1 randomized pilot study.
The trial evaluates the safety and efficacy of intravascular lithotripsy in comparison to standard lesion preparation using standard and/or high-pressure balloon angioplasty in patients with femoropopliteal artery disease. All patients will receive subsequent Supera stent implantation at the operator's discretion. Additional standard nitinol bare metal stent (BMS), drug-eluting stent or covered stent implantation is at the operator's discretion.
Patients will be stratified for total occlusions.
All enrolled subjects will be followed up through 60 months. At 6, 12, 24, 36 MFU after index procedure the incidence of restenosis will be assessed by DUS.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →University of Leipzig is the lead sponsor of 148 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with Lithotripsy system followed by Supera stent implantation in lesion segments with severe calcification.
Procedure: Intravascular lithotripsy
Treatment with Balloon angioplasty with a conventional and/or high-pressure balloon angioplasty followed by Supera stent implantation in lesion segments with severe calcification.
Procedure: Standard lesion preparation
Lesion preparation with Shockwave Medical Peripheral Lithotripsy System
Lesion preparation with Standard and/or High-Pressure Balloon Angioplasty
Primary efficacy
Procedural success defined as residual stenosis ≤ 30% without flow-limiting dissection (≥Grade D) in the final angiogram and without the need of additional stent implantation.
Time frame: During the Procedure
Rate of primary outcome events
Composite endpoint defined as freedom from device and procedure-related death, freedom from both target limb major amputation and clinically-driven target lesion revascularization
Time frame: 12 month
Rate of vessel rupture
Rate of vessel rupture
Time frame: During the Procedure
Need of additional stent implantation
Need of additional stent implantation
Time frame: During the Procedure
Procedure Time (min)
Procedure Time (min)
Time frame: During the Procedure
Fluoroscopy Duration (min)
Fluoroscopy Duration (min)
Time frame: During the Procedure
Radiation dose area product
Radiation dose area product
Time frame: During the Procedure
Additional need of intra-procedural pain medication
Additional need of intra-procedural pain medication
Time frame: During the Procedure
Perception of procedural pain evaluated using a numerical rating scale from 0 (no pain) to 10 (severest pain)
Perception of procedural pain evaluated using a numerical rating scale from 0 (no pain) to 10 (severest pain)
Time frame: During the Procedure
Rate of any dissections after lesion preparation and in the final angiogram
Rate of any dissections after lesion preparation and in the final angiogram
Time frame: During the Procedure
Rate of primary patency
Rate of primary patency
Time frame: 6, 12, 24 and 36 months
Rate of Duplex-defined binary restenosis (PVR >2.4) of the target lesion
Rate of Duplex-defined binary restenosis (PVR \>2.4) of the target lesion
Time frame: post-procedure until discharge from hospital (up to 48 hours) and at 6, 12, 24 and 36 months or at any time of re-intervention
Rate of Clinically-driven Target lesion revascularization
Rate of Clinically-driven Target lesion revascularization
Time frame: 30 days, 6, 12, 24, 36, 48 and 60 months
Rate of Freedom from Major Adverse Event (defined as death, Target lesion revascularization, Target vessel revascularization and target limb major amputation)
Rate of Freedom from Major Adverse Event (defined as death, Target lesion revascularization, Target vessel revascularization and target limb major amputation)
Time frame: 30 days, 6, 12, 24, 36, 48 and 60 months
Rate of All-cause mortality
Rate of All-cause mortality
Time frame: 30 days, 6, 12, 24, 36, 48 and 60 months
Ankle-brachial index (ABI)
The ABI is calculated by dividing the highest of the dorsalis pedis and posterior tibial pressures in each leg by the highest of the brachial pressures. Value less than 0.90 indicates a diagnosis of PAD.
Time frame: 6, 12, 24 and 36 months
Rutherford Classification
Rutherford Classification Scale from 0=Asymptomatic, 1=Mild claudication, 2=Moderate claudication, 3=Severe claudication, 4=Ischemic rest pain, 5=Minor tissue loss up to worst classification 6=Major tissue loss
Time frame: 6, 12, 24 and 36 months
Walking Impairment Questionnaire (WIQ)
The products are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficult with any of the tasks).
Time frame: 6, 12, 24 and 36 months
EQ-5D-5L questionnaire
The EQ-5D-5L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: o problems, slight problems, moderate problems, severe problems and extreme problems.
Time frame: 6, 12, 24 and 36 months
EQ VAS
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 100% 'Best imaginable health state' and 0% 'Worst imaginable health state'.
Time frame: 6, 12, 24 and 36 months
Plan to share: No
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