search
Back to results

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

Primary Purpose

Peripheral Artery Disease, PAD, Claudication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stealth 360°® OAS
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring Peripheral Artery Disease, PAD, Claudication, Peripheral Vascular Disease, PVD, Orbital Atherectomy, Balloon Angioplasty, Intravascular Ultrasound (IVUS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU School of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

OAS + BA

Arm Description

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

Outcomes

Primary Outcome Measures

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.
Mean Maximum Balloon Inflation Pressure
Mean maximum balloon inflation pressure of balloons used pre-stent placement.
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).
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.
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
Stent Usage at the Time of the Index Procedure
Number of lesions with a stent placed during the 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).

Secondary Outcome Measures

Full Information

First Posted
March 12, 2013
Last Updated
July 14, 2023
Sponsor
Abbott Medical Devices
search

1. Study Identification

Unique Protocol Identification Number
NCT01938391
Brief Title
Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal
Acronym
TRUTH
Official Title
Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal (TRUTH Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease, PAD, Claudication, Peripheral Vascular Disease, PVD
Keywords
Peripheral Artery Disease, PAD, Claudication, Peripheral Vascular Disease, PVD, Orbital Atherectomy, Balloon Angioplasty, Intravascular Ultrasound (IVUS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OAS + BA
Arm Type
Other
Arm Description
Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)
Intervention Type
Device
Intervention Name(s)
Stealth 360°® OAS
Intervention Description
Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
Primary Outcome Measure Information:
Title
Rate of Clinically Driven Target Lesion Revascularization (TLR)
Description
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
Title
Mean Maximum Balloon Inflation Pressure
Description
Mean maximum balloon inflation pressure of balloons used pre-stent placement.
Time Frame
Index Procedure
Title
Rate of Procedural Angiographic Complications
Description
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
Title
Ankle-Brachial Index (ABI) Measurments
Description
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
Title
Rutherford Classification (RC)
Description
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
Title
Stent Usage at the Time of the Index Procedure
Description
Number of lesions with a stent placed during the index procedure.
Time Frame
Index Procedure
Title
Percent (%) Area Stenosis
Description
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).
Time Frame
Index Procedure (pre-procedure, post-OAS treatment and post-balloon treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anvar Babaev, MD
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
CSI has no plans to share IPD with other researchers
Citations:
PubMed Identifier
26490645
Citation
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.
Results Reference
result
PubMed Identifier
27864454
Citation
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.
Results Reference
result

Learn more about this trial

Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

We'll reach out to this number within 24 hrs