Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-02-28

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).

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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.

Conditions

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Peripheral Artery Disease PAD Claudication Peripheral Vascular Disease PVD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OAS + BA

Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)

Group Type OTHER

Stealth 360°® OAS

Intervention Type DEVICE

Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)

Interventions

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Stealth 360°® OAS

Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No