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Trial record 1 of 1 for:    NCT04663867
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AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study) (RESTOR-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04663867
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : November 25, 2022
Sponsor:
Collaborator:
Veranex, Inc.
Information provided by (Responsible Party):
AngioSafe, Inc.

Study Description
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Brief Summary:
The study is designed to evaluate the safety and efficacy of the AngioSafe Peripheral CTO Crossing System.

Condition or disease Intervention/treatment Phase
Peripheral Artery Occlusion Peripheral Arterial Disease Device: AngioSafe Peripheral CTO Crossing System Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness Study of the AngioSafe Peripheral CTO Crossing System
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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.

  2. 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.

  3. Evaluation of intraluminal CTO crossing facilitated by the Peripheral CTO Crossing System, as assessed by an Intravascular Ultrasound (IVUS). [ Time Frame: Procedure ]
  4. The primary endpoint in the subgroup of the degree of calcification (none/focal/mild/moderate, severe). [ Time Frame: Procedure ]

Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663867


Contacts
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Contact: Mallik Thatipelli, MD 669-400-8383 mallik@angiosafe.com

Locations
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Sponsors and Collaborators
AngioSafe, Inc.
Veranex, Inc.
Investigators
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Principal Investigator: Subhash Banerjee, MD North Texas Veterans Healthcare System
More Information
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Responsible Party: AngioSafe, Inc.
ClinicalTrials.gov Identifier: NCT04663867    
Other Study ID Numbers: 0071
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: November 25, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases