Clinical trial NCT04663867: AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study)
Official title: Safety and Effectiveness Study of the AngioSafe Peripheral CTO Crossing System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Occlusion
Peripheral Arterial Disease
Lead sponsor: AngioSafe, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Veranex, Inc.
First posted: 2020-12-11
Enrollment: 133
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate the safety and efficacy of the AngioSafe Peripheral CTO Crossing System.

Detailed description: The purpose of the study is to demonstrate the safety and effectiveness of the AngioSafe Peripheral CTO Crossing System. The system facilitates the crossing of chronic total occlusions (CTOs) in the peripheral arteries of lower limbs. A minimum of 70 subjects will be treated across selected study enters within the U.S. and followed for 30 days.

Eligibility criteria: Inclusion Criteria:

* Able and willing to comply with protocol requirements and sign informed consent form
* ≥ 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))

Angiographic Inclusion Criteria:

* 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:

* Systemic infection or an infection in extremity of target lesion
* 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

Primary outcomes:
measure: Clinical Success of AngioSafe Peripheral CTO Crossing System
timeFrame: 24 Hours
Secondary outcomes:
measure: Technical Success of AngioSafe Peripheral CTO Crossing System
timeFrame: Procedure
measure: Procedural Success of AngioSafe Peripheral CTO Crossing System
timeFrame: 30 Days
measure: Evaluation of intraluminal CTO crossing facilitated by the Peripheral CTO Crossing System, as assessed by an Intravascular Ultrasound (IVUS).
timeFrame: Procedure
measure: The primary endpoint in the subgroup of the degree of calcification (none/focal/mild/moderate, severe).
timeFrame: Procedure
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Dignity Health - Chandler Regional Medical Center
state: Arizona
city: Saint Helena
country: United States
facility: Adventist Health St. Helena
state: California
city: Darien
country: United States
facility: Vascular Care Connecticut
state: Connecticut
city: Miami Beach
country: United States
facility: Palm Vascular Centers
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular & Interventional, PLLC
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Wellesley
country: United States
facility: Vascular Care Group
state: Massachusetts
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital South
state: Missouri
city: West Orange
country: United States
facility: American Endovascular & Amputation Prevention
state: New Jersey
city: Cary
country: United States
facility: Vascular Solutions of North Carolina
state: North Carolina
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Kingsport
country: United States
facility: Wellmont Cardiology Services
state: Tennessee
city: Dallas
country: United States
facility: VA North Texas Medical Center
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White, The Heart Hospital Plano
state: Texas
city: Tyler
country: United States
facility: Cardiovascular Associated of East Texas
state: Texas
Study officials:
affiliation: North Texas Veterans Healthcare System
name: Subhash Banerjee, MD
role: PRINCIPAL_INVESTIGATOR
References: