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

Primary Purpose

Peripheral Artery Occlusion, Peripheral Arterial Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AngioSafe Peripheral CTO Crossing System
Sponsored by
AngioSafe, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Occlusion

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dignity Health - Chandler Regional Medical CenterRecruiting
  • Southwest Cardiovascular Associates
  • Adventist Health St. HelenaRecruiting
  • Vascular Care ConnecticutRecruiting
  • Yale New Haven Hospital
  • Palm Vascular CentersRecruiting
  • Coastal Vascular & Interventional, PLLCRecruiting
  • Piedmont Heart InstituteRecruiting
  • Midwest Cardiovascular Research FoundationRecruiting
  • Cardiovascular Institute of the SouthRecruiting
  • Vascular Care GroupRecruiting
  • Saint Luke's Hospital of Kansas CityRecruiting
  • Mercy Hospital SouthRecruiting
  • American Endovascular & Amputation PreventionRecruiting
  • Vascular Solutions of North CarolinaRecruiting
  • Novant Health Heart & Vascular Institute
  • The Miriam HospitalRecruiting
  • Wellmont Cardiology ServicesRecruiting
  • VA North Texas Medical CenterRecruiting
  • Baylor Scott & White, The Heart Hospital PlanoRecruiting
  • Cardiovascular Associated of East TexasRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AngioSafe Peripheral CTO Crossing System Procedure

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Technical Success of AngioSafe Peripheral CTO Crossing System
Defined as the ability of catheter to facilitate placement of a guidewire into the distal lumen.
Procedural Success of AngioSafe Peripheral CTO Crossing System
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.
Evaluation of intraluminal CTO crossing facilitated by the Peripheral CTO Crossing System, as assessed by an Intravascular Ultrasound (IVUS).
The primary endpoint in the subgroup of the degree of calcification (none/focal/mild/moderate, severe).

Full Information

First Posted
December 1, 2020
Last Updated
November 22, 2022
Sponsor
AngioSafe, Inc.
Collaborators
Veranex, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04663867
Brief Title
AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study)
Acronym
RESTOR-1
Official Title
Safety and Effectiveness Study of the AngioSafe Peripheral CTO Crossing System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AngioSafe, Inc.
Collaborators
Veranex, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Occlusion, Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AngioSafe Peripheral CTO Crossing System Procedure
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AngioSafe Peripheral CTO Crossing System
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Technical Success of AngioSafe Peripheral CTO Crossing System
Description
Defined as the ability of catheter to facilitate placement of a guidewire into the distal lumen.
Time Frame
Procedure
Title
Procedural Success of AngioSafe Peripheral CTO Crossing System
Description
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.
Time Frame
30 Days
Title
Evaluation of intraluminal CTO crossing facilitated by the Peripheral CTO Crossing System, as assessed by an Intravascular Ultrasound (IVUS).
Time Frame
Procedure
Title
The primary endpoint in the subgroup of the degree of calcification (none/focal/mild/moderate, severe).
Time Frame
Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mallik Thatipelli, MD
Phone
669-400-8383
Email
mallik@angiosafe.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subhash Banerjee, MD
Organizational Affiliation
North Texas Veterans Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dignity Health - Chandler Regional Medical Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georges Nseir, MD
First Name & Middle Initial & Last Name & Degree
Natalie Leon
Phone
480-728-8736
First Name & Middle Initial & Last Name & Degree
Georges Nseir, MD
Facility Name
Southwest Cardiovascular Associates
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85208
Country
United States
Individual Site Status
Withdrawn
Facility Name
Adventist Health St. Helena
City
Saint Helena
State/Province
California
ZIP/Postal Code
94754
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer DeBattista
Email
DeBattJL@ah.org
First Name & Middle Initial & Last Name & Degree
Ehrin Armstrong, MD
Facility Name
Vascular Care Connecticut
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Gagne, MD
First Name & Middle Initial & Last Name & Degree
Maria Myslinski, RN, CEN
Email
clinicaltrials@vascularbreakthroughs.com
First Name & Middle Initial & Last Name & Degree
Paul Gagne, MD
First Name & Middle Initial & Last Name & Degree
Ben Chandler, MD
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Withdrawn
Facility Name
Palm Vascular Centers
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Beasley, MD
First Name & Middle Initial & Last Name & Degree
Jennifer Gimeno
Phone
305-608-1221
First Name & Middle Initial & Last Name & Degree
Robert Beasley, MD
First Name & Middle Initial & Last Name & Degree
Warren Swee, MD
First Name & Middle Initial & Last Name & Degree
Timothy Yates, MD
Facility Name
Coastal Vascular & Interventional, PLLC
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Bosarge, MD
First Name & Middle Initial & Last Name & Degree
Kelly Stewart
Phone
850-494-1108
First Name & Middle Initial & Last Name & Degree
Christopher Bosarge, MD
First Name & Middle Initial & Last Name & Degree
Shonak Patel, MD
First Name & Middle Initial & Last Name & Degree
Fernando Kafie, MD
First Name & Middle Initial & Last Name & Degree
Christopher LeCroy, MD
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Klein, MD
First Name & Middle Initial & Last Name & Degree
Wendy Nolan
Phone
470-631-9998
First Name & Middle Initial & Last Name & Degree
Andrew Klein, MD
First Name & Middle Initial & Last Name & Degree
Andrew Unzeitig, MD
Facility Name
Midwest Cardiovascular Research Foundation
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Shammas, MD
First Name & Middle Initial & Last Name & Degree
Gail Shammas, BSN, CCRC
Phone
563-324-2828
First Name & Middle Initial & Last Name & Degree
Nicolas Shammas, MD
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Walker, MD
First Name & Middle Initial & Last Name & Degree
Darla Patrick, RN
Phone
985-573-5684
First Name & Middle Initial & Last Name & Degree
Craig Walker, MD
First Name & Middle Initial & Last Name & Degree
Pardeep Nair, MD
First Name & Middle Initial & Last Name & Degree
Matthew Finn, MD
Facility Name
Vascular Care Group
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
06820
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Kwolek, MD
First Name & Middle Initial & Last Name & Degree
Maria Myslinski, RN, CEN
Email
clinicaltrials@vascularbreakthroughs.com
First Name & Middle Initial & Last Name & Degree
Christopher Kwolek, MD
First Name & Middle Initial & Last Name & Degree
Sebastian DiDato, MD
First Name & Middle Initial & Last Name & Degree
Todd Lancaster, MD
First Name & Middle Initial & Last Name & Degree
Edward Arous, MD
First Name & Middle Initial & Last Name & Degree
Stephen Hoenig, MD
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Bunte, MD
First Name & Middle Initial & Last Name & Degree
Megan Warden
Phone
816-287-6223
First Name & Middle Initial & Last Name & Degree
Matthew Bunte, MD
First Name & Middle Initial & Last Name & Degree
Steven Laster, MD
First Name & Middle Initial & Last Name & Degree
Kimberly Campbell, APRN
First Name & Middle Initial & Last Name & Degree
Dany Jacob, MD
Facility Name
Mercy Hospital South
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anish Thomas, MD
First Name & Middle Initial & Last Name & Degree
Carol Mechem, RN, CCRC
Phone
314-525-1697
First Name & Middle Initial & Last Name & Degree
Anish Thomas, MD
Facility Name
American Endovascular & Amputation Prevention
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Rundback, MD
First Name & Middle Initial & Last Name & Degree
Kristen Hlozek, PhD
Email
kristen@lebecc.com
First Name & Middle Initial & Last Name & Degree
John Rundback, MD
Facility Name
Vascular Solutions of North Carolina
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siddhartha Rao, MD
First Name & Middle Initial & Last Name & Degree
Meaghan Thomas
Phone
919-897-5999
First Name & Middle Initial & Last Name & Degree
Siddhartha Rao, MD
Facility Name
Novant Health Heart & Vascular Institute
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Hyder, MD
First Name & Middle Initial & Last Name & Degree
Bailey Nevins
Phone
401-793-4105
First Name & Middle Initial & Last Name & Degree
Omar Hyder, MD
First Name & Middle Initial & Last Name & Degree
Peter Soukas, MD
Facility Name
Wellmont Cardiology Services
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Metzger, MD
First Name & Middle Initial & Last Name & Degree
Terrie Walker, MBA, BSN, RN
Phone
423-230-5643
First Name & Middle Initial & Last Name & Degree
Chris Metzger, MD
Facility Name
VA North Texas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirling Tsai, MD
First Name & Middle Initial & Last Name & Degree
Cristina Sanchez
Phone
214-857-3048
First Name & Middle Initial & Last Name & Degree
Shirling Tsai, MD
Facility Name
Baylor Scott & White, The Heart Hospital Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Das, MD
First Name & Middle Initial & Last Name & Degree
Osniel Gonzales Ramos
Phone
469-814-4862
First Name & Middle Initial & Last Name & Degree
Tony Das, MD
First Name & Middle Initial & Last Name & Degree
Sameh Sayfo, MD
First Name & Middle Initial & Last Name & Degree
Chadi Dib, MD
Facility Name
Cardiovascular Associated of East Texas
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Carr, MN
First Name & Middle Initial & Last Name & Degree
Trisha Mahomes
Phone
903-595-2283
First Name & Middle Initial & Last Name & Degree
Jeffrey Carr, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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