AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study)
NCT ID: NCT04663867
Last Updated: 2024-11-04
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
133 participants
INTERVENTIONAL
2021-02-03
2023-06-15
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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AngioSafe Peripheral CTO Crossing System Procedure
Use of AngioSafe Peripheral CTO Crossing System to facilitate the intraluminal placement of guidewires beyond Chronic Total Occlusions (CTOs) in the peripheral vasculature.
AngioSafe Peripheral CTO Crossing System
The AngioSafe Peripheral CTO Crossing System is intended to facilitate the intraluminal placement of guidewires beyond stenotic lesions, including chronic total occlusions (CTOs) in the peripheral vasculature.
Interventions
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AngioSafe Peripheral CTO Crossing System
The AngioSafe Peripheral CTO Crossing System is intended to facilitate the intraluminal placement of guidewires beyond stenotic lesions, including chronic total occlusions (CTOs) in the peripheral vasculature.
Eligibility Criteria
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Inclusion Criteria
* ≥ 22 years of age
* Peripheral arterial disease defined by Rutherford Clinical Classification (Category 2-5)
* Peripheral artery disease in target extremity is confirmed by imaging (catheter angiography, computed tomographic angiography (CTA), and/or magnetic resonance angiography (MRA))
* Target lesion in native de novo common femoral artery (CFA), superficial femoral artery (SFA), and/or popliteal artery
* Vessel diameter(s) for target lesion is ≥ 3.0mm and ≤ 10mm
* Subject's target lesion is a severely stenosed segment of ≤ 300 mm that involves the CTO(s)
* Subject's target lesion involves at least one CTO that is 99-100% stenosed
* Subject has at least one vessel with run-off to the foot
Exclusion Criteria
* Target lesion within native vein or synthetic vessel grafts or in stent occlusion
* Planned intervention in the contralateral limb during the study
* Planned intervention in the target limb of the inflow vessels during the study
* Planned intervention of lower extremities after study procedure within 30-day follow-up visit
* Coagulopathy or bleeding diatheses, thrombocytopenia with platelet count less than 50,000/μl, or INR \> 1.7
* Antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated
* Allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated
* Allergy to nickel, titanium, urethane, nylon, or silicone
* History of myocardial infarction within 30 days prior to enrollment/consent
* History of stroke within 30 days prior to enrollment/consent
* Chronic kidney disease (CKD) of stage 4 or greater based on an Estimated Glomerular Filtration Rate (eGFR) \<30ml/Min, unless the subject is on chronic renal replacement therapy
* Hemoglobin levels \<10g/dL verified by a lab test no older than 14 days prior to enrollment, unless the subject has a history of chronic anemia at a stable level, no recent bleeding diathesis or history of blood transfusion in the last six weeks
* Pregnant or nursing, for females of child-bearing potential (\< 50 years of age)
* Participating in another interventional research study that may interfere with study endpoints
* Prior major amputation (above ankle) in target extremity
* Acute limb ischemia (ALI)
* Prior unsuccessful attempt to cross the target lesion
* Subject has had a procedure on the target limb or contralateral limb within 7 days
* Subject has had a procedure on the target limb or contralateral limb within the past 30 days and is unstable
22 Years
ALL
No
Sponsors
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Veranex, Inc.
UNKNOWN
AngioSafe, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Subhash Banerjee, MD
Role: PRINCIPAL_INVESTIGATOR
North Texas Veterans Healthcare System
Locations
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Dignity Health - Chandler Regional Medical Center
Chandler, Arizona, United States
Adventist Health St. Helena
St. Helena, California, United States
Vascular Care Connecticut
Darien, Connecticut, United States
Palm Vascular Centers
Miami Beach, Florida, United States
Coastal Vascular & Interventional, PLLC
Pensacola, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Vascular Care Group
Wellesley, Massachusetts, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
American Endovascular & Amputation Prevention
West Orange, New Jersey, United States
Vascular Solutions of North Carolina
Cary, North Carolina, United States
The Miriam Hospital
Providence, Rhode Island, United States
Wellmont Cardiology Services
Kingsport, Tennessee, United States
VA North Texas Medical Center
Dallas, Texas, United States
Baylor Scott & White, The Heart Hospital Plano
Plano, Texas, United States
Cardiovascular Associated of East Texas
Tyler, Texas, United States
Countries
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Other Identifiers
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0071
Identifier Type: -
Identifier Source: org_study_id
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