Peripheral Artery OcclusionRESTOR-1NCT04663867
AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study)
A study testing AngioSafe Peripheral CTO Crossing System in people with Peripheral Artery Occlusion and Peripheral Arterial Disease, run by AngioSafe, Inc. at 18 sites in United States.
Trial summary
The study is designed to evaluate the safety and efficacy of the AngioSafe Peripheral CTO Crossing System. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Peripheral Artery Occlusion, Peripheral Arterial Disease
- What is being tested?
- AngioSafe Peripheral CTO Crossing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 18 sitesUnited States
- Study dates
- 3 Feb 2021to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
Vascular Solutions of North Carolina
Cary, North Carolina, 27518
Dignity Health - Chandler Regional Medical Center
Chandler, Arizona, 85224
VA North Texas Medical Center
Dallas, Texas, 75216
Vascular Care Connecticut
Darien, Connecticut, 06820
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52801
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Wellmont Cardiology Services
Kingsport, Tennessee, 37660
Palm Vascular Centers
Miami Beach, Florida, 33140
Coastal Vascular & Interventional, PLLC
Pensacola, Florida, 32504
Baylor Scott & White, The Heart Hospital Plano
Plano, Texas, 75093
The Miriam Hospital
Providence, Rhode Island, 02906
Mercy Hospital South
St Louis, Missouri, 63128
Adventist Health St. Helena
St. Helena, California, 94754
Cardiovascular Associated of East Texas
Tyler, Texas, 75701
Vascular Care Group
Wellesley, Massachusetts, 06820
American Endovascular & Amputation Prevention
West Orange, New Jersey, 07052
About this study
Official title: 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.
Read the 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.
- Being tested
- AngioSafe Peripheral CTO Crossing System
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioSafe Peripheral CTO Crossing SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| AngioSafe Peripheral CTO Crossing System Procedure | Experimental | Use of AngioSafe Peripheral CTO Crossing System to facilitate the intraluminal placement of guidewires beyond Chronic Total Occlusions (CTOs) in the peripheral vasculature. Receives: Device: AngioSafe Peripheral CTO Crossing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Hours
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start3 Feb 2021
- Primary completion25 Apr 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Artery OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- AngioSafe, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veranex, Inc.
- Responsible party
- Sponsor
- Investigators
- Subhash Banerjee, MD, Principal investigator, North Texas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663867
- Sponsor's protocol ID
- 0071
- Acronym
- RESTOR-1
- Status last verified
- Feb 2026
- First submitted
- 1 Dec 2020
- Last updated
- 12 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Study of the AngioSafe Peripheral CTO Crossing System
- ClinicalTrials.gov ID
- NCT04663867
- Acronym / sponsor ID
- RESTOR-1 / 0071
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- AngioSafe, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Veranex, Inc.
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Posted 12 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AngioSafe Peripheral CTO Crossing System Procedure | Experimental | Device: AngioSafe Peripheral CTO Crossing SystemUse of AngioSafe Peripheral CTO Crossing System to facilitate the intraluminal placement of guidewires beyond Chronic Total Occlusions (CTOs) in the peripheral vasculature. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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))
- Target lesion in native de novo common femoral artery (CFA), superficial femoral artery (SFA), and/or popliteal artery
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AngioSafe Peripheral CTO Crossing SystemThe 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. | Device | AngioSafe Peripheral CTO Crossing System Procedure |
Primary outcome
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.
4 secondary outcomes
Technical Success of AngioSafe Peripheral CTO Crossing System
Time frame: Procedure, evaluated directly after performing the investigational procedure
Procedural Success of AngioSafe Peripheral CTO Crossing System
Time frame: 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
The Primary Endpoint (Clinical Success) in the Subgroups by the Degree of Calcification (None/Focal/Mild, and Moderate/Severe).
Time frame: 24-hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subhash Banerjee, MD principal investigator
North Texas Veterans Healthcare System
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AngioSafe Peripheral CTO Crossing System in people with Peripheral Artery Occlusion and Peripheral Arterial Disease, run by AngioSafe, Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success of AngioSafe Peripheral CTO Crossing System (time frame: 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.