An observational study in Peripheral Arterial Disease, Superficial Femoral Artery Stenosis and Calcifications Vascular, sponsored by Marc Bosiers, MD. Completed at 6 sites in Germany. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Marc Bosiers, MD · Observational
The objective of this clinical investigation is to evaluate, in a controlled setting, the 12 months safety and efficacy of the combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device, for PACSS 3 and PACSS 4 calcified femoropopliteal disease.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's enrollment of 50 is below the median of 188 across 398 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Marc Bosiers, MD is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient population for this study are patients with a diminished blood flow in their heavily calcified femoropopliteal lesions, who need a reintervention.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Stenotic, restenotic after PTA or occlusive lesion(s) located in the native Superficial Femoral Artery (SFA) and/or proximal Popliteal Artery (PPA):
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Subject must be between 21 and 85 years old * Clinical diagnosis of symptomatic peripheral artery disease, defined by Rutherford Becker Classification score 3-5 * Willing to comply with the specified follow-up evaluation * Written informed consent prior to any study procedures
Device: Peripheral lithotripsy system (Shockwave Medical)
The combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device for calcified femoropopliteal disease.
Primary Patency
Defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (\>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR)
Time frame: 12 months
Procedural success:
Defined as technical success and completion of the procedure without complications , meaning successful treatment of the vessels (technical success) in the absence of: * vessel rupture or perforation that require an intervention * need for emergency surgical revascularization of target limb * symptomatic thrombus or distal emboli that require surgical, mechanical, or pharmacologic means to improve flow and extend hospitalization * unplanned above the ankle amputation * major adverse cardiovascular events (defined as composite of total death, myocardial infarction, coronary revascularization and stroke).
Time frame: 30 days post procedure
Primary Patency
Defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (\>50 systolic velocity ratio no greater than 2,4) and without Target Lesion Revascularization (TLR)
Time frame: 6 months
Target Lesion Revascularization (TLR)
Defined as the need for target lesion revascularization after index procedure.
Time frame: 6- and 12-months
Secondary Patency Rate
Defined as restored flow in the treated segment after occlusion or restenosis.
Time frame: 6- and 12-months
Amputation-free Survival rate
Defined as the time until a major amputation of the index limb and/or death of any cause, whichever occurred first.
Time frame: 6- and 12-months
Major Amputation Rate
Defined as any aboveankle amputation.
Time frame: 6- and 12-months
Clinical Success
Defined as an improvement of the Rutherford Becker Classification of one class or more, as compared to the preprocedure Rutherford Becker Classification.
Time frame: 6- and 12-months
Absence of Major Adverse Events (MAE)
Acute Coronary Syndrome, Stroke, Death, Major Amputation or TLR.
Time frame: 6- and 12-months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2022 to primary completion in Sep 2025, 38 months.
Of 138 non-industry observational studies under Peripheral Arterial Disease, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 116. This study's 38 months is close to that.
Counting every sponsor, half of 196 studies reached it within 36 months; a quarter within 22 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Marc Bosiers, MD