CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).
This prospective, randomized, multi-center, post-market study of approximately 50 subjects randomized 1:1 to Orbital Atherectomy (OA) performed with Cardiovascular Systems, Inc.'s Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) vs. BA alone for treatment of tibial vessel disease, defined as ≥ 50 % stenosis of the anterior tibial (AT), posterior tibial (PT), tibial peroneal trunk (TPT), or peroneal (PR) arteries by angiography. All subjects will have a corresponding wound being fed by the target vessel which will be assessed during the study. Subjects will be followed to one year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
Type of balloon selected is driven by preference of the operator.
Arkansas Heart Clinic
Little Rock, Arkansas, United States
Northside Hospital
Atlanta, Georgia, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
Percentage of Calcium Removal Out of Lumen Gain as Assessed by IVUS
The post-treatment percentage of calcium removal out of lumen gain at the maximum calcium ablation site. A positive value equates to reduction in calcium out of the lumen gain.
Time frame: Post-balloon angioplasty
Change in Minimum Lumen Area Percent Stenosis as Assessed by IVUS
The pre- (Pre-Tx) and post-treatment (Post-Tx) minimum lumen area percent stenosis. A positive value equates to a decrease in lumen area percent stenosis.
Time frame: Pre-intervention, and post-balloon angioplasty
Change in Plaque Area as Assessed by IVUS
The pre- (Pre-Tx) and post-treatment (Post-Tx) plaque area. A positive value equates to a decrease in plaque area.
Time frame: Pre-intervention, and post-balloon angioplasty
Change in Dense Calcium Area as Assessed by IVUS
The pre- (Pre-Tx) and post-treatment (Post-Tx) dense calcium area. A positive value equates to a decrease in dense calcium area.
Time frame: Pre-intervention, and post-balloon angioplasty
Change in Necrotic Core Area as Assessed by IVUS
The pre- (Pre-Tx) and post-treatment (Post-Tx) necrotic core area. A positive value equates to a decrease necrotic core area.
Time frame: Pre-intervention, and post-balloon angioplasty
Change in Fibrous Plaque Area as Assessed by IVUS
The pre- (Pre-Tx) and post-treatment (Post-Tx) fibrous plaque area. A positive value equates to a decrease in fibrous plaque area.
Time frame: Pre-intervention, and post-balloon angioplasty
Change in Fibrofatty Plaque Area as Assessed by IVUS
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Holy Name Medical Center
Teaneck, New Jersey, United States
Rex Hospital
Raleigh, North Carolina, United States
Mission Research Institute
New Braunfels, Texas, United States
Sentara Vascular Specialists
Norfolk, Virginia, United States
The pre- (Pre-Tx) and post-treatment (Post-Tx) fibrofatty plaque area. A positive value equates to a decrease in fibrofatty plaque area.
Time frame: Pre-intervention, and post-balloon angioplasty
Fractional Flow Reserve
Fractional flow reserve (FFR) will be measured to assess hemodynamic function following each device procedure. During FFR, adenosine will be given through the femoral artery sheath or access catheter in two doses: 600 mcg and 1200 mcg. A higher FFR is presumed to correlate to better flow which may improve wound healing.
Time frame: Post-orbital atherectomy (OA arm only) and post-balloon angioplasty (both arms)