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

February 10, 2026 updated by: AngioSafe, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
79

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Success of AngioSafe Peripheral CTO Crossing System
Time Frame: 24 Hours
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical Success of AngioSafe Peripheral CTO Crossing System
Time Frame: Procedure, evaluated directly after performing the investigational procedure
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
Time Frame: 30 Days
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).
Time Frame: Procedure, evaluated directly after performing the investigational procedure
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).
Time Frame: 24-hours
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lesion Crossing Time, Mean
Time Frame: Procedure, evaluated during the investigational procedure
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
Time Frame: Procedure, evaluated during the investigational procedure
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
Time Frame: Baseline, 30-days
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
Time Frame: Baseline, 30-days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AngioSafe, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Veranex, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Subhash Banerjee, MD, North Texas Veterans Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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