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Completed

NCT Number: NCT01938391

Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

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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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Claudication Intermittent Claudication PAD PVD Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stealth 360°® OAS

Device

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

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: TRUTH

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 10, 2013
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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