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

NCT04663867 | Completed Results FDA Device

• 1 other identifier: 0071
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 18

Brief Summary

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

Conditions

Peripheral Artery Occlusion; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Technical Success of AngioSafe Peripheral CTO Crossing System

  Procedure, evaluated directly after performing the investigational procedure

• Procedural Success of AngioSafe Peripheral CTO Crossing System

  30 Days

• Evaluation of Intraluminal CTO Crossing Facilitated by the Peripheral CTO Crossing System, as Assessed by an Intravascular Ultrasound (IVUS).

  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).

  24-hours

Other Outcomes (4)

• Lesion Crossing Time, Mean

  Procedure, evaluated during the investigational procedure

• Lesion Crossing Time, Median

  Procedure, evaluated during the investigational procedure

• Rutherford Clinical Classification (RCC) Assessment

  Baseline, 30-days

Study Arms (1)

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.

Device: AngioSafe Peripheral CTO Crossing System

Interventions

AngioSafe Peripheral CTO Crossing System DEVICE

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.

AngioSafe Peripheral CTO Crossing System Procedure

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AngioSafe, Inc.: lead
• Veranex, Inc.: collaborator

Study Sites (18)

Dignity Health - Chandler Regional Medical Center

Chandler, Arizona, 85224, United States

Location

Adventist Health St. Helena

St. Helena, California, 94754, United States

Location

Vascular Care Connecticut

Darien, Connecticut, 06820, United States

Location

Palm Vascular Centers

Miami Beach, Florida, 33140, United States

Location

Coastal Vascular & Interventional, PLLC

Pensacola, Florida, 32504, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52801, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Vascular Care Group

Wellesley, Massachusetts, 06820, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Mercy Hospital South

St Louis, Missouri, 63128, United States

Location

American Endovascular & Amputation Prevention

West Orange, New Jersey, 07052, United States

Location

Vascular Solutions of North Carolina

Cary, North Carolina, 27518, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Wellmont Cardiology Services

Kingsport, Tennessee, 37660, United States

Location

VA North Texas Medical Center

Dallas, Texas, 75216, United States

Location

Baylor Scott & White, The Heart Hospital Plano

Plano, Texas, 75093, United States

Location

Cardiovascular Associated of East Texas

Tyler, Texas, 75701, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Head of Clinical Affairs
• Organization: AngioSafe, Inc.

info@angiosafe.com

8883479438

Study Officials

• Subhash Banerjee, MD

  North Texas Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 11, 2020
• Study Start: February 3, 2021
• Primary Completion: April 25, 2023
• Study Completion: June 15, 2023
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)