Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2022-09-05
2024-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intravascular lithotripsy
Intravascular Lithotripsy
Enhancing percutaneous transluminal angioplasty by utilizing delivery of IVL to disrupt calcium in below the knee lesions prior to full balloon dilatation at low pressures
Interventions
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Intravascular Lithotripsy
Enhancing percutaneous transluminal angioplasty by utilizing delivery of IVL to disrupt calcium in below the knee lesions prior to full balloon dilatation at low pressures
Eligibility Criteria
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Inclusion Criteria
* Rutherford Clinical Category 2 - 5.
* Single or multiple target lesion(s) is/are located in a de novo artery distal to the trifurcation vessels and extends to and ends above the ankle
* Calcification is at least moderate (presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending ≥ 50% the length of the lesion or absolute length ≥20mm
Exclusion Criteria
* Significant stenosis (\>50% stenosis) or occlusion of inflow tract (e.g., iliac or common femoral) not successfully treated with PTA, stent or Lithotripsy and without complications
* Planned major amputation of the target leg.
* Previously implanted stent in the treatment lesion
18 Years
ALL
No
Sponsors
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Bolt Medical
INDUSTRY
Responsible Party
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Locations
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Medical University of Graz
Graz, , Austria
University Hospital of Split
Split, , Croatia
Klinikum Hochsauerland GmbH
Arnsberg, , Germany
Vilnius University Hospital Santaros clinics
Vilnius, , Lithuania
Countries
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Other Identifiers
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TP-001700
Identifier Type: -
Identifier Source: org_study_id
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