[Trial of device that is not approved or cleared by the U.S. FDA]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- [Redacted]
- Enrollment
- 15
- Status
- Withheld
- Last Updated
- last year
Overview
Brief Summary
This research study is to learn more about the safety and effectiveness of a medical device called the "AngioSafe Peripheral-5 CTO Crossing System." This device is used as part of a medical procedure to restore blood flow of people with complete blockages (chronic total occlusions, or CTOs) in an arterial blood vessel of the leg below the knee. To fix the blockage the doctor must first deliver a guidewire through it so that other medical devices can be used to reduce the blockage. In this trial, the AngioSafe Peripheral-5 CTO Crossing System is the medical device that will be used to deliver the guidewire through the blockage. This will allow other devices needed for the procedure, such as treatment balloons and stents, to be used to open a pathway for blood to flow to the legs.
Detailed Description
The study will last for about 30 days after the procedure (for a total of about 4-8 weeks from the time the patient consents to participate) and involves 3 visits, including 1 visit to determine eligibility to participate, 1 visit for the procedure and hospital stay, and 1 visit at about 30 days after the procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subject is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form (ICF).
- •Subject is ≥22 years of age at the time of enrollment/consent.
- •Subject has symptomatic peripheral arterial disease as defined by the Rutherford Clinical Classification (Category 2 "Moderate claudication" through Category 5 "Minor tissue loss - nonhealing ulcer, focal gangrene with diffuse pedal ischemia").
- •Peripheral artery disease in the affected extremity is confirmed by imaging including at least one of the following: catheter-based angiography (preferably selective, digital subtraction, with visible ruler), Computed Tomographic Angiography (CTA), Magnetic Resonance Angiography (MRA), and/or Duplex Ultrasound Sonography (DUS).
- •Approval of subject's anatomical eligibility by an independent Screening Committee.
- •Angiographic Inclusion Criteria
- •Study target lesion is in native de novo tibioperoneal trunk, anterior tibial, posterior tibial and peroneal arteries.
- •Reference vessel diameter(s) for subject's target lesion is ≥2.0mm and ≤5mm by visual estimate.
- •The target lesion is a severely stenosed segment of ≤100mm in length that involves the CTO(s).
- •The target lesion involves at least one CTO that is angiographically ≥99% stenosed.
Exclusion Criteria
- •Subject has a systemic infection or an infection in the extremity of the target lesion.
- •The target lesion is within native vein or synthetic vessel grafts or is in-stent occlusion.
- •The contralateral limb requires planned intervention concurrently with the study procedure.
- •The target limb requires intervention of a CTO in the inflow vessels concurrently with the study procedure.
- •The target limb requires traversing a stented segment with the investigational device (not contained within a sheath of delivery catheter) in the inflow vessels during the study procedure.
- •Subject requires planned intervention of the lower extremities after the study procedure within the timeframe for the 30-day follow-up visit.
- •Subject has a known coagulopathy or bleeding diatheses, thrombocytopenia with platelet counts less than 50,000/μl, or INR \>1.7 (unless corrected prior to procedure, as verified by a lab test no older than 5 days prior to the investigational procedure).
- •Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
- •Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
- •Subject has known allergy to nickel, titanium, urethane, nylon, or silicone.
Outcomes
Primary Outcomes
Not specified