Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

N/ACompletedNCT01938391

Abbott Medical Devices25 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Artery Disease PAD Claudication Peripheral Vascular Disease PVD

Interventions

Stealth 360°® OASDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

NYU School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months and 12 months

Mean Maximum Balloon Inflation Pressure

Mean maximum balloon inflation pressure of balloons used pre-stent placement.

Time frame: 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).

Time frame: 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.

Time frame: 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

Time frame: Baseline, 2 weeks, 6 month and 12 month

Stent Usage at the Time of the Index Procedure

Data from ClinicalTrials.gov

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