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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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-10-31
2025-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Serrantor
Subjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon
Serranator PTA Serration Catheter
The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
PTA
Subjects randomized to the PTA Arm of the study will be treated with a standard of care percutaneous transluminal angioplasty (PTA) balloon.
PTA (Standard of Care)
A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.
Interventions
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Serranator PTA Serration Catheter
The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
PTA (Standard of Care)
A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.
Eligibility Criteria
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Inclusion Criteria
* Age of subjects is \>18 years old
* Patients has given informed consent to participate in this study
Exclusion Criteria
* Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries.
* Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm.
* Lesion length less than 220 mm
19 Years
ALL
No
Sponsors
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Cagent Vascular LLC
INDUSTRY
Responsible Party
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Locations
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Columbia University
New York, New York, United States
Weill Cornell Medical
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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K Dalton
Role: primary
R Chu
Role: primary
Other Identifiers
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CSP
Identifier Type: -
Identifier Source: org_study_id
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