Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

Not Applicable

Completed

Conditions: Claudication
Peripheral Artery Disease
PAD
Peripheral Vascular Disease
PVD

Interventions: Device: Stealth 360°® OAS

Registration Number: NCT01938391

Lead Sponsor: Abbott Medical Devices

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OAS + BA	Stealth 360°® OAS	Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)

Primary Outcome Measures

Name	Time	Method
Ankle-Brachial Index (ABI) Measurments	Baseline, 2 weeks, 6 months and 12 months	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.
Rutherford Classification (RC)	Baseline, 2 weeks, 6 month and 12 month	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
Stent Usage at the Time of the Index Procedure	Index Procedure	Number of lesions with a stent placed during the index procedure.
Rate of Clinically Driven Target Lesion Revascularization (TLR)	6 months and 12 months	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.
Mean Maximum Balloon Inflation Pressure	Index Procedure	Mean maximum balloon inflation pressure of balloons used pre-stent placement.
Rate of Procedural Angiographic Complications	Index Procedure	Percent of study participants with an Investigator reported procedural angiographic complication (flow limiting dissection, perforation, slow flow/no flow, distal embolization and recoil).
Percent (%) Area Stenosis	Index Procedure (pre-procedure, post-OAS treatment and post-balloon treatment)	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).