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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01938391
Recruitment Status : Completed
First Posted : September 10, 2013
Results First Posted : August 18, 2017
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Systems Inc

Study Description
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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).

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease PAD Claudication Peripheral Vascular Disease PVD Device: Stealth 360°® OAS Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal (TRUTH Study)
Study Start Date : January 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

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MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Clinically Driven Target Lesion Revascularization (TLR) [ Time Frame: 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.

  2. Mean Maximum Balloon Inflation Pressure [ Time Frame: Index Procedure ]
    Mean maximum balloon inflation pressure of balloons used pre-stent placement.

  3. Rate of Procedural Angiographic Complications [ Time Frame: 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).

  4. Ankle-Brachial Index (ABI) Measurments [ Time Frame: 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.

  5. Rutherford Classification (RC) [ Time Frame: 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


  6. Stent Usage at the Time of the Index Procedure [ Time Frame: Index Procedure ]
    Number of lesions with a stent placed during the index procedure.

  7. Percent (%) Area Stenosis [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938391


Locations
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United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
Cardiovascular Systems Inc
Investigators
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Principal Investigator: Anvar Babaev, MD NYU Langone Medical Center
More Information
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Publications of Results:

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Responsible Party: Cardiovascular Systems Inc
ClinicalTrials.gov Identifier: NCT01938391    
Other Study ID Numbers: TRUTH
First Posted: September 10, 2013    Key Record Dates
Results First Posted: August 18, 2017
Last Update Posted: February 12, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: CSI has no plans to share IPD with other researchers
Keywords provided by Cardiovascular Systems Inc:
Peripheral Artery Disease
PAD
Claudication
Peripheral Vascular Disease
 PVD
Orbital Atherectomy
Balloon Angioplasty
Intravascular Ultrasound (IVUS)
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Arterial Disease
Intermittent Claudication
Peripheral Vascular Diseases
 Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases