New Shockwave-Stent combo tackles tough leg artery blockages
NCT ID NCT05291247
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed study tested a two-step treatment for severely calcified leg artery disease in 50 patients. First, a shockwave device cracks the hard calcium deposits, then a drug-coated stent is placed to keep the artery open. The goal was to see if this approach is safe and effective at maintaining blood flow for 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Shockwave intravascular lithotripsy device and a drug-eluting vascular stent
- What this could lead to
- If successful, this combination could offer a safer, more effective way to open severely calcified leg arteries, reducing the need for repeat procedures.
- What could go wrong
- This is a small, completed trial with 50 participants, so results may not apply to everyone. The procedure carries risks like vessel rupture, blood clots, or heart complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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50 people
The number who actually took part.
- Started
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Jul 2022
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patient population for this study are patients with a diminished blood flow in their heavily calcified femoropopliteal lesions, who need a reintervention.
- Ages
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21 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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): 1. Degree of stenosis ≥ 70% by visual agiographic assessment 2. Vessel diameter ≥ 4 and ≥ 6 mm 3. 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) 4. 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. Exclusion Criteria: * 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 * 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Klinikum Hochsauerland
Arnsberg, North Rhine-Westphalia, 59759, Germany
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SRH Klinikum Karlsbad-Langensteinbach
Baden-Baden, Baden-Wurttemberg, 76307, Germany
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St. Marien Hospital Lünen
Lünen, North Rhine-Westphalia, 44534, Germany
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University Hospital Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
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University Hospital Essen
Essen, North Rhine-Westphalia, 45147, Germany
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University Hospital LMU Munich
Munich, Bavaria, 80337, Germany
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