Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

Study Overview
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Brief Summary
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IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have symptomatic peripheral artery disease (PAD) occurring in the Superficial Femoral Artery (SFA), Popliteal (POP), and/or Tibioperoneal Trunk (TPT).

Detailed Description
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This study is a prospective, single-arm (non-randomized), post-market study which will enroll up to 25 subjects. Intravascular Ultrasound (IVUS) imaging and angiography will be used to assess procedural outcomes in patients who have symptomatic peripheral artery disease who are treated with the Sponsor's OAS and adjunctive balloon angioplasty. An independent IVUS Core Lab will be used to provide adjudicated analyses for IVUS outcomes. In clinic follow-up visits will be performed at 2 weeks, 6 months and at 12 months.

Official Title
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Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal (TRUTH Study)

Conditions
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Peripheral Artery Disease, PAD, Claudication, Peripheral Vascular Disease, PVD

Intervention / Treatment
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* Device: Stealth 360°® OAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject's age ≥ 18 years Subject is an acceptable candidate for percutaneous intervention using the Sponsor's OAS in accordance with its labeled indications and instructions for use Target lesion(s) located in a superficial femoral artery (SFA), popliteal (POP) or tibioperoneal trunk (TPT) Tight lesions (>70% stenosis) Lesions less than 110 mm in length Artery with the vessel < 6.5 mm in diameter Subject is willing and able to sign an approved informed consent form Subject is willing and able to attend follow-up visits Exclusion Criteria: Uncontrolled allergy to nitinol, stainless-steel or other stent materials or to contrast agent Unable to take appropriate antiplatelet therapy Subject has no distal run-off Interventional treatment is intended for in-stent restenosis at the peripheral vascular site Subject has history of coagulopathy or hypercoagulable disorder, is undergoing hemodialysis or has impaired renal function (Cr > 2.5 mg/dl) at the time of treatment Female subject who is pregnant or nursing a child Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Sponsor's OAS

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: OAS + BA<br>Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) | Device: Stealth 360°® OAS<br>* Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Clinically Driven Target Lesion Revascularization (TLR) | A Kaplan-Meier analysis was performed to determine the percent probability that a study participant had a TLR at 6 months and at 12 months. | 6 months and 12 months | 
| Mean Maximum Balloon Inflation Pressure | Mean maximum balloon inflation pressure of balloons used pre-stent placement. | Index Procedure | 
| Rate of Procedural Angiographic Complications | Percent of study participants with an Investigator reported procedural angiographic complication (flow limiting dissection, perforation, slow flow/no flow, distal embolization and recoil). | Index Procedure | 
| Ankle-Brachial Index (ABI) Measurments | The ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial (upper arm) artery. Normal range of ABI is 0.9 - 1.2. Values less than 0.9 suggests presence of peripheral artery disease (PAD). Values greater than 1.2 suggests of non-compressible vessel. | Baseline, 2 weeks, 6 months and 12 months | 
| Rutherford Classification (RC) | Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD. The RC is assessed for each participant at baseline and at each follow-up visit. RC classification is as follows: RC 0: Asymptomatic, no hemodynamically significant occlusive disease RC 1-3: Mild to Severe Claudication, limitation with ordinary physical activities, patient is comfortable at rest RC 4-5: Ischemic rest pain, minor tissue loss, non healing ulcer, focal gangrene RC 6: Major tissue loss, functional foot no longer salvageable | Baseline, 2 weeks, 6 month and 12 month | 
| Stent Usage at the Time of the Index Procedure | Number of lesions with a stent placed during the index procedure. | Index Procedure | 
| Percent (%) Area Stenosis | Percentage (%) of area stenosis as assessed by the intravascular ultrasound (IVUS) Core Lab. Percentage of area stenosis was calculated as 1 - (minimum lumen area / reference lumen area). | Index Procedure (pre-procedure, post-OAS treatment and post-balloon treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Artery Disease, PAD, Claudication, Peripheral Vascular Disease, PVD, Orbital Atherectomy, Balloon Angioplasty, Intravascular Ultrasound (IVUS)