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

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

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).

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease; Peripheral Artery Disease; Claudication; PAD; PVD
• Intervention / Treatment: Device: Stealth 360°® OAS

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Anvar Babaev, MD, NYU Langone Medical Center

Publications and helpful links

General Publications

• Babaev A, Zavlunova S, Attubato MJ, Martinsen BJ, Mintz GS, Maehara A. Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study). Vasc Endovascular Surg. 2015 Oct;49(7):188-94. doi: 10.1177/1538574415607361. Epub 2015 Oct 20.
• Krishnan P, Martinsen BJ, Tarricone A, Babaev A, Maehara A. Minimal Medial Injury After Orbital Atherectomy. J Endovasc Ther. 2017 Feb;24(1):167-168. doi: 10.1177/1526602816678033. Epub 2016 Nov 19. No abstract available.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: March 12, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (Estimated): September 10, 2013

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: PAD; Claudication; Peripheral Vascular Disease; Peripheral Artery Disease; PVD; Orbital Atherectomy; Balloon Angioplasty; Intravascular Ultrasound (IVUS)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: TRUTH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: CSI has no plans to share IPD with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No