Peripheral Arterial DiseaseShockwave DESNCT05291247
Shockwave IVL + DES
An observational study of Peripheral Arterial Disease and Superficial Femoral Artery Stenosis, run by Marc Bosiers, MD at 6 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Calcifications Vascular
- What is being tested?
- Peripheral lithotripsy system (Shockwave Medical)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 6 sitesGermany
- Study dates
- 22 Jul 2022to 10 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient population for this study are patients with a diminished blood flow in their heavily calcified femoropopliteal lesions, who need a reintervention.
Who may be able to join
- 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
- Stenotic, restenotic after PTA or occlusive lesion(s) located in the native Superficial Femoral Artery (SFA) and/or proximal Popliteal Artery (PPA):
- Degree of stenosis ≥ 70% by visual agiographic assessment
Show all 13Show fewer
- Vessel diameter ≥ 4 and ≥ 6 mm
- Total lesion length (or series of lesions) ≥ 30 mm and 210 mm (Note: Lesion segment(s) must be filly covered with one or two overlapping DES stent (s) be fully covered with one or two overlapping DES stent(s)
- Target lesion located at least three centimeters above the inferior edge of the femur
- Severity of calcification PACSS 3-4
- Patent infrapopliteal and popliteal artery; i.e. single vessel runoff or better with at least one of three vessels patent (>50% stenosis) to the ankle or foot with no planned intervention.
- Study entry after successful target lesion crossing of the guidewire (guidewire located intraluminally or subintimally); Both crossing devices as well as retrograde recanalization can be used.
- Non-target lesion interventions to restore adequate blood flow, in the same index procedure are allowed. This intervention must be prior to the treatment of the study lesion and should be completed successfully.
Who cannot join
- Not treated ipsilateral significant (>50%) stenosis of the iliac arteries
- Non severely calcified disease (absence of calcification, PACSS 1, PACSS 2)
- Significant (>50%) stenosis of all infrapopliteal arteries, no patent artery to the foot
- Angiographic evidence of thrombus within the target vessel
- Thrombolysis within 72 hours prior to the index procedure
- Previously stented target lesion / vessel
Show all 18Show fewer
- Subjects who have undergone prior surgery of the target lesion SFA/PPA to treat atherosclerotic disease
- Bypass Anastomosis stenosis
- Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
- Recent MI or stroke <30 days prior to the index procedure
- Life expectancy less than 24 months
- Known or suspected active infection at the time of the index procedure
- Known or suspected major allergies or contraindications to aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or contrast agent
- Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimalparticipation in the study
- The subject is currently participating in another drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
- Female subjects pregnant, breastfeeding, of childbearing potential who are planning to become pregnant in the next 5 years.
- End-stage-renal disease
- Presence of Severe Ischemic Ulcers or frank gangrene (Rutherford class 6).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Klinikum Hochsauerland
Arnsberg, North Rhine-Westphalia, 59759
SRH Klinikum Karlsbad-Langensteinbach
Baden-Baden, Baden-Wurttemberg, 76307
University Hospital Essen
Essen, North Rhine-Westphalia, 45147
University Hospital Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
St. Marien Hospital Lünen
Lünen, North Rhine-Westphalia, 44534
University Hospital LMU Munich
Munich, Bavaria, 80337
About this study
Official title: Physician-Initiated PMCF Trial Investigating Shockwave Intravascular Lithotripsy and a Drug Eluting Vascular Stent System Deployment for Heavily Calcified Femoropopliteal Disease
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.
- Being tested
- Peripheral lithotripsy system (Shockwave Medical)
- Medical subject headings
- Peripheral Arterial Disease, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral lithotripsy system (Shockwave Medical)Device
The combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device for calcified femoropopliteal disease.
| Study group | Role | What they receive |
|---|---|---|
| Heavily calcified femoropopliteal disease | * 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 Receives: Device: Peripheral lithotripsy system (Shockwave Medical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 30 days post procedure
Secondary outcomes (7)
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)
Measured: 6 months
Target Lesion Revascularization (TLR)
Defined as the need for target lesion revascularization after index procedure.
Measured: 6- and 12-months
Secondary Patency Rate
Defined as restored flow in the treated segment after occlusion or restenosis.
Measured: 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.
Measured: 6- and 12-months
Major Amputation Rate
Defined as any aboveankle amputation.
Measured: 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.
Measured: 6- and 12-months
Absence of Major Adverse Events (MAE)
Acute Coronary Syndrome, Stroke, Death, Major Amputation or TLR.
Measured: 6- and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start22 Jul 2022
- Primary completion23 Sep 2025
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marc Bosiers, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marc Bosiers, MD, FCRE (Foundation for Cardiovascular Research and Education)
- Investigators
- Konstantinos Stavroulakis, MD, Principal investigator, Vascular Department, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291247
- Sponsor's protocol ID
- FCRE-210505
- Acronym
- Shockwave DES
- Status last verified
- Apr 2026
- First submitted
- 21 Nov 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician-Initiated PMCF Trial Investigating Shockwave Intravascular Lithotripsy and a Drug Eluting Vascular Stent System Deployment for Heavily Calcified Femoropopliteal Disease
- ClinicalTrials.gov ID
- NCT05291247
- Acronym / sponsor ID
- Shockwave DES / FCRE-210505
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Marc Bosiers, MDUniversity, hospital or other
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 22 Mar 2022 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heavily calcified femoropopliteal disease | – | Device: Peripheral lithotripsy system (Shockwave Medical)* 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 |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient population for this study are patients with a diminished blood flow in their heavily calcified femoropopliteal lesions, who need a reintervention.
Key inclusion criteria (13 listed)
- 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
- Stenotic, restenotic after PTA or occlusive lesion(s) located in the native Superficial Femoral Artery (SFA) and/or proximal Popliteal Artery (PPA):
Key exclusion criteria (18 listed)
- Not treated ipsilateral significant (>50%) stenosis of the iliac arteries
- Non severely calcified disease (absence of calcification, PACSS 1, PACSS 2)
- Significant (>50%) stenosis of all infrapopliteal arteries, no patent artery to the foot
- Angiographic evidence of thrombus within the target vessel
- Thrombolysis within 72 hours prior to the index procedure
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 |
|---|---|---|
| Peripheral lithotripsy system (Shockwave Medical)The combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device for calcified femoropopliteal disease. | Device | Heavily calcified femoropopliteal disease |
Primary outcome
Primary Patency
Time frame: 12 months
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)
Procedural success:
Time frame: 30 days post procedure
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).
7 secondary outcomes
Primary Patency
Time frame: 6 months
Target Lesion Revascularization (TLR)
Time frame: 6- and 12-months
Secondary Patency Rate
Time frame: 6- and 12-months
Amputation-free Survival rate
Time frame: 6- and 12-months
Major Amputation Rate
Time frame: 6- and 12-months
Clinical Success
Time frame: 6- and 12-months
Absence of Major Adverse Events (MAE)
Time frame: 6- and 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Peripheral Arterial Disease
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism
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. This study is not recruiting at the moment.
Konstantinos Stavroulakis, MD principal investigator
Vascular Department, LMU Munich
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Superficial Femoral Artery Stenosis, run by Marc Bosiers, MD at 6 sites in Germany.
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 13 inclusion and 18 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: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency (time frame: 12 months). 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?
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 27 Apr 2026.