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

November 22, 2022 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

Recruiting

Conditions

Intervention / Treatment

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 (Anticipated)

100

Phase

  • 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 Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Dignity Health - Chandler Regional Medical Center
        • Contact:
          • Georges Nseir, MD
        • Contact:
          • Natalie Leon
          • Phone Number: 480-728-8736
      • Mesa, Arizona, United States, 85208
        • Withdrawn
        • Southwest Cardiovascular Associates
    • California
      • Saint Helena, California, United States, 94754
        • Recruiting
        • Adventist Health St. Helena
        • Contact:
    • Connecticut
      • Darien, Connecticut, United States, 06820
      • New Haven, Connecticut, United States, 06510
        • Withdrawn
        • Yale New Haven Hospital
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Palm Vascular Centers
        • Principal Investigator:
          • Robert Beasley, MD
        • Contact:
          • Robert Beasley, MD
        • Contact:
          • Jennifer Gimeno
          • Phone Number: 305-608-1221
        • Sub-Investigator:
          • Warren Swee, MD
        • Sub-Investigator:
          • Timothy Yates, MD
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • Coastal Vascular & Interventional, PLLC
        • Contact:
          • Christopher Bosarge, MD
        • Contact:
          • Kelly Stewart
          • Phone Number: 850-494-1108
        • Principal Investigator:
          • Christopher Bosarge, MD
        • Sub-Investigator:
          • Shonak Patel, MD
        • Sub-Investigator:
          • Fernando Kafie, MD
        • Sub-Investigator:
          • Christopher LeCroy, MD
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Heart Institute
        • Contact:
          • Andrew Klein, MD
        • Contact:
          • Wendy Nolan
          • Phone Number: 470-631-9998
        • Principal Investigator:
          • Andrew Klein, MD
        • Sub-Investigator:
          • Andrew Unzeitig, MD
    • Iowa
      • Davenport, Iowa, United States, 52801
        • Recruiting
        • Midwest Cardiovascular Research Foundation
        • Contact:
          • Nicolas Shammas, MD
        • Contact:
          • Gail Shammas, BSN, CCRC
          • Phone Number: 563-324-2828
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Recruiting
        • Cardiovascular Institute of the South
        • Principal Investigator:
          • Craig Walker, MD
        • Contact:
          • Darla Patrick, RN
          • Phone Number: 985-573-5684
        • Sub-Investigator:
          • Pardeep Nair, MD
        • Sub-Investigator:
          • Matthew Finn, MD
    • Massachusetts
      • Wellesley, Massachusetts, United States, 06820
        • Recruiting
        • Vascular Care Group
        • Contact:
        • Contact:
          • Christopher Kwolek, MD
        • Principal Investigator:
          • Christopher Kwolek, MD
        • Sub-Investigator:
          • Sebastian Didato, MD
        • Sub-Investigator:
          • Todd Lancaster, MD
        • Sub-Investigator:
          • Edward Arous, MD
        • Sub-Investigator:
          • Stephen Hoenig, MD
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Hospital of Kansas City
        • Contact:
          • Matthew Bunte, MD
        • Contact:
          • Megan Warden
          • Phone Number: 816-287-6223
        • Principal Investigator:
          • Matthew Bunte, MD
        • Sub-Investigator:
          • Steven Laster, MD
        • Sub-Investigator:
          • Kimberly Campbell, APRN
        • Sub-Investigator:
          • Dany Jacob, MD
      • Saint Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Contact:
          • Anish Thomas, MD
        • Contact:
          • Carol Mechem, RN, CCRC
          • Phone Number: 314-525-1697
        • Principal Investigator:
          • Anish Thomas, MD
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Recruiting
        • American Endovascular & Amputation Prevention
        • Contact:
          • John Rundback, MD
        • Contact:
        • Principal Investigator:
          • John Rundback, MD
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Recruiting
        • Vascular Solutions of North Carolina
        • Contact:
          • Siddhartha Rao, MD
        • Contact:
          • Meaghan Thomas
          • Phone Number: 919-897-5999
        • Principal Investigator:
          • Siddhartha Rao, MD
      • Matthews, North Carolina, United States, 28105
        • Withdrawn
        • Novant Health Heart & Vascular Institute
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • The Miriam Hospital
        • Contact:
          • Omar Hyder, MD
        • Contact:
          • Bailey Nevins
          • Phone Number: 401-793-4105
        • Principal Investigator:
          • Omar Hyder, MD
        • Sub-Investigator:
          • Peter Soukas, MD
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Recruiting
        • Wellmont Cardiology Services
        • Principal Investigator:
          • Chris Metzger, MD
        • Contact:
          • Chris Metzger, MD
        • Contact:
          • Terrie Walker, MBA, BSN, RN
          • Phone Number: 423-230-5643
    • Texas
      • Dallas, Texas, United States, 75216
        • Recruiting
        • VA North Texas Medical Center
        • Contact:
          • Shirling Tsai, MD
        • Contact:
          • Cristina Sanchez
          • Phone Number: 214-857-3048
        • Principal Investigator:
          • Shirling Tsai, MD
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott & White, The Heart Hospital Plano
        • Contact:
          • Tony Das, MD
        • Contact:
          • Osniel Gonzales Ramos
          • Phone Number: 469-814-4862
        • Principal Investigator:
          • Tony Das, MD
        • Sub-Investigator:
          • Chadi Dib, MD
      • Tyler, Texas, United States, 75701
        • Recruiting
        • Cardiovascular Associated of East Texas
        • Contact:
          • Jeffrey Carr, MN
        • Contact:
          • Trisha Mahomes
          • Phone Number: 903-595-2283
        • Principal Investigator:
          • Jeffrey Carr, MD

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

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Intervention / Treatment
Experimental: AngioSafe Peripheral CTO Crossing System Procedure
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
Time Frame
Clinical Success is defined as Technical Success in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner.
Time Frame: 24 Hours
24 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success of AngioSafe Peripheral CTO Crossing System
Time Frame: Procedure
Defined as the ability of catheter to facilitate placement of a guidewire into the distal lumen.
Procedure
Procedural Success of AngioSafe Peripheral CTO Crossing System
Time Frame: 30 Days
Defined as Technical Success 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
Procedure
The primary endpoint in the subgroup of the degree of calcification (none/focal/mild/moderate, severe).
Time Frame: Procedure
Procedure

Collaborators and Investigators

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

Sponsor

AngioSafe, Inc.

Collaborators

Veranex, Inc.

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)

February 1, 2021

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 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)

November 25, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

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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