AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study) (RESTOR-1)

Safety and Effectiveness Study of the AngioSafe Peripheral CTO Crossing System

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

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Peripheral Artery Occlusion
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Dignity Health - Chandler Regional Medical Center
  • California
    • St. Helena, California, United States, 94754
      • Adventist Health St. Helena
  • Connecticut
    • Darien, Connecticut, United States, 06820
      • Vascular Care Connecticut
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Palm Vascular Centers
    • Pensacola, Florida, United States, 32504
      • Coastal Vascular & Interventional, PLLC
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
  • Iowa
    • Davenport, Iowa, United States, 52801
      • Midwest Cardiovascular Research Foundation
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
  • Massachusetts
    • Wellesley, Massachusetts, United States, 06820
      • Vascular Care Group
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
    • St Louis, Missouri, United States, 63128
      • Mercy Hospital South
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • American Endovascular & Amputation Prevention
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Vascular Solutions of North Carolina
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Cardiology Services
  • Texas
    • Dallas, Texas, United States, 75216
      • VA North Texas Medical Center
    • Plano, Texas, United States, 75093
      • Baylor Scott & White, The Heart Hospital Plano
    • Tyler, Texas, United States, 75701
      • Cardiovascular Associated of East Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success of AngioSafe Peripheral CTO Crossing System	Clinical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner.	24 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success of AngioSafe Peripheral CTO Crossing System	Technical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen.	Procedure, evaluated directly after performing the investigational procedure
Procedural Success of AngioSafe Peripheral CTO Crossing System	Procedural Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen without a procedural complication within 30 days after the procedure. Procedural complication is defined as the need for open or repeat endovascular surgical repair in the treated limb, or a major bleeding event.	30 Days
Evaluation of Intraluminal CTO Crossing Facilitated by the Peripheral CTO Crossing System, as Assessed by an Intravascular Ultrasound (IVUS).	Post-procedure IVUS evaluation of Technical Success cases to determine if crossing was performed intraluminally.	Procedure, evaluated directly after performing the investigational procedure
The Primary Endpoint (Clinical Success) in the Subgroups by the Degree of Calcification (None/Focal/Mild, and Moderate/Severe).	Clinical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner, analyzed by degree of calcification in two subgroups: None/Focal/Mild calcification, or Moderate/Severe calcification.	24-hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion Crossing Time, Mean	Lesion crossing time is defined as time starting from the placement of the Peripheral CTO Crossing System at the proximal cap to the time the guidewire is placed in the distal true vessel lumen.	Procedure, evaluated during the investigational procedure
Lesion Crossing Time, Median	Lesion crossing time is defined as time starting from the placement of the Peripheral CTO Crossing System at the proximal cap to the time the guidewire is placed in the distal true vessel lumen.	Procedure, evaluated during the investigational procedure
Rutherford Clinical Classification (RCC) Assessment	The mean change in the Rutherford Clinical Classification (RCC) assessment at 30 days versus baseline. The Rutherford Clinical Classification (RCC) Scale identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. The RCC Scale Categories and associated Clinical Descriptions are as follows: 0 - Asymptomatic, 1 - Mild claudication, 2- Moderate claudication, 3 - Severe claudication, 4 - Ischemic rest pain, 5 - Minor tissue loss, 6 - Ulceration or gangrene.	Baseline, 30-days
Pain Numeric Rating Scale (NRS) Assessment	The mean change in Pain Numeric Rating Scale (NRS) assessment at 30-days versus baseline. The Pain Numeric Rating Scale (Pain NRS) is a unidimensional measure of pain intensity in adults. The NRS is anchored by terms describing pain severity extremes, where 0 represents no pain and 10 represents the worst pain possible. The NRS Ratings and associated Clinical Descriptions are as follows: 0 - No Pain, 1-3 - Mild Pain, 4-6 - Moderate Pain, 7-9 - Severe Pain, 10 - Worst Pain Possible.	Baseline, 30-days

Collaborators and Investigators

• Sponsor: AngioSafe, Inc.
• Collaborators: Veranex, Inc.
• Investigators: Principal Investigator: Subhash Banerjee, MD, North Texas Veterans Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Actual): April 25, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 5, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 0071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes