This is a prospective, multi-center, non-randomized single arm feasibility trial of the Wolverine OCT guided atherectomy system.The trial will enroll up to 50 subjects diagnosed with peripheral vascular disease of the lower extremities.The primary disease must be located in reference vessel diameters ≥ 2.5 mm which is significant enough to cause moderate to severe symptoms and warrant vascular intervention.
This is a prospective, multi-center, non-randomized single arm feasibility trial of the Wolverine OCT guided atherectomy system. The trial is predominantly descriptive and, as such, not powered statistically although endpoint comparisons may be made to the published literature on peripheral atherectomy. The trial will enroll up to 50 subjects diagnosed with peripheral vascular disease of the lower extremities. The primary disease must be located in reference vessel diameters ≥ 3.0 mm which is significant enough to cause moderate to severe symptoms and warrant vascular intervention. Trial success is focused on short term safety including rates of major adverse events. An evaluation of efficacy will also be performed and will include an evaluation of technical success defined as the percent of target lesions that has a residual diameter stenosis \<50% post the Wolverine device alone as assessed by an independent review at the time of treatment using quantitative angiography or visual estimate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Angiografia de Occidente
Cali, VAC, Colombia
Clinical Cardiovascular
Medellín, Colombia
Number of Participants With no Major Adverse Events
Freedom from major adverse events (MAE) through 30 day follow-up: * Clinically driven target lesion revascularization (TLR) * Myocardial infarct (MI) * Cardiovascular related deaths * Unplanned, major index limb amputation * Device Related Events: * Clinically Significant Perforations * Clinically Significant Dissections * Clinically Significant Embolus * Pseudoaneurysm
Time frame: Through 30 day follow-up
Technical Success: Percent of Target Lesions That Have a Residual Diameter Stenosis < 50%
Technical success is defined as the percent of target lesions that has a residual diameter stenosis \< 50% post the Wolverine device alone as assessed by an independent review at the time of treatment using quantitative angiography or visual estimate
Time frame: During interventional procedure
Procedural Success: Percent of Target Lesions That Have Residual Diameter Stenosis ≤30% Post-Wolverine and Any Other Adjunctive Therapy
Time frame: Day 0
Number of Participants With no Procedural Emboli
A procedural emboli is defined as a new occlusion of any visualized runoff vessel which cannot be reversed with an intravascular vasodilator.
Time frame: During interventional procedure
Ankle-Brachial Index (ABI) at 30 Days
Ankle-Brachial Index (ABI) is the ratio of blood pressure in the lower legs to the blood pressure in the arms. It is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm. ABI \< 0.95 indicates arterial disease; ABI between 0.95 and 1.3 is considered normal (free from significant peripheral artery disease); ABI \> 1.3 is abnormal, and suggests calcification of the artery walls and incompressible vessels, indicating severe peripheral vascular disease.
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Time frame: At 30 days
Rutherford Classification at 30 Days Post-procedure
Rutherford Classification is a commonly used clinical means for describing the degree of peripheral artery disease. Rutherford Classifications range from Class 0: Asymptomatic, to Class 6: Major Tissue Loss. A lower score is less severe disease and a higher score is more severe disease progression.
Time frame: At 30 days