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

  • days left to enroll
  • participants needed
  • sponsor
    AngioSafe, Inc.
Updated on 17 June 2022
magnetic resonance angiography


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


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.

Condition Peripheral Artery Occlusion, Peripheral Arterial Disease
Treatment AngioSafe Peripheral CTO Crossing System
Clinical Study IdentifierNCT04663867
SponsorAngioSafe, Inc.
Last Modified on17 June 2022


Yes No Not Sure

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
Target lesion is a severely stenosed segment of ≤ 200mm that involves the CTO(s)
Target lesion involves at least one CTO, i.e., is deemed as total occlusion (100% stenosis)
At least one patent tibial vessel (≤ 70% stenosis) 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
Coagulopathy or bleeding diatheses, thrombocytopenia with platelet count less than 50,000/μl, or INR > 1.7
Planned intervention of lower extremities after study procedure within 30-day follow-up visit
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
Hemoglobin levels <10g/dL verified by a lab test no older than 14 days prior to enrollment
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
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How to participate?

Step 1 Connect with a study center
What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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