Peripheral Arterial Disease, Peripheral Artery Occlusion
Conditions
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.
Interventions
DEVICEAngioSafe 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.
Sponsors
AngioSafe, Inc.
Veranex, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success of AngioSafe Peripheral CTO Crossing System | 24 Hours | Clinical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success of AngioSafe Peripheral CTO Crossing System | Procedure, evaluated directly after performing the investigational procedure | Technical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen. |
| Procedural Success of AngioSafe Peripheral CTO Crossing System | 30 Days | Procedural Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen 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). | Procedure, evaluated directly after performing the investigational procedure | Post-procedure IVUS evaluation of Technical Success cases to determine if crossing was performed intraluminally. |
| The Primary Endpoint (Clinical Success) in the Subgroups by the Degree of Calcification (None/Focal/Mild, and Moderate/Severe). | 24-hours | Clinical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner, analyzed by degree of calcification in two subgroups: None/Focal/Mild calcification, or Moderate/Severe calcification. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSubhash Banerjee, MD
North Texas Veterans Healthcare System
Participant flow
Pre-assignment details
The study enrolled a total of 79 participants, with only 74 participants analyzed for effectiveness Outcome Measures. Study results (Outcome Measures) are reported for the 74 participants in the "Full Analysis Set (FAS)" Group described below. The 5 excluded participants are described in in other study Groups, excluded from effectiveness analyses, but included in the safety analyses (Adverse Event reporting).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 69.4 years STANDARD_DEVIATION 9.02 |
| Arterial Access Type Primary Access Antegrade Femoral | 12 Participants |
| Arterial Access Type Primary Access Pedal | 0 Participants |
| Arterial Access Type Primary Access Popliteal | 0 Participants |
| Arterial Access Type Primary Access Retrograde Femoral | 62 Participants |
| Arterial Access Type Secondary Access Antegrade Femoral | 2 Participants |
| Arterial Access Type Secondary Access Pedal | 9 Participants |
| Arterial Access Type Secondary Access Popliteal | 0 Participants |
| Arterial Access Type Secondary Access Retrograde Femoral | 1 Participants |
| Race/Ethnicity, Customized Black, non-Hispanic | 8 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants |
| Race/Ethnicity, Customized Other, non-Hispanic | 1 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 61 Participants |
| Region of Enrollment United States | 74 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 79 |
| other Total, other adverse events | 39 / 79 |
| serious Total, serious adverse events | 5 / 79 |
Outcome results
None listed