Peripheral Artery DiseaseTRUTHNCT01938391
Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal
A study testing Stealth 360°® OAS in people with Peripheral Artery Disease and PAD, run by Abbott Medical Devices at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease, PAD, Claudication
- What is being tested?
- Stealth 360°® OAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Peripheral Artery Disease, PAD, Claudication, Peripheral Vascular Disease, PVD
- Being tested
- Stealth 360°® OAS
- Keywords
- Peripheral Artery Disease, PAD, Claudication, Peripheral Vascular Disease, PVD, Orbital Atherectomy, Balloon Angioplasty, Intravascular Ultrasound (IVUS)
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stealth 360°® OASDevice
Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
| Study group | Role | What they receive |
|---|---|---|
| OAS + BA | Other | Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) Receives: Device: Stealth 360°® OAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months and 12 months
Mean Maximum Balloon Inflation Pressure
Mean maximum balloon inflation pressure of balloons used pre-stent placement.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: Index Procedure (pre-procedure, post-OAS treatment and post-balloon treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anvar Babaev, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938391
- Sponsor's protocol ID
- TRUTH
- Acronym
- TRUTH
- Status last verified
- Jul 2023
- First submitted
- 12 Mar 2013
- Last updated
- 18 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: CSI has no plans to share IPD with other researchers
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.
PubMed 26490645Krishnan 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.
PubMed 27864454
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal (TRUTH Study)
- ClinicalTrials.gov ID
- NCT01938391
- Acronym / sponsor ID
- TRUTH / TRUTH
- Conditions
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Posted 18 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OAS + BA | Other | Device: Stealth 360°® OASCardiovascular Systems, Inc. Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stealth 360°® OASCardiovascular Systems, Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA) | Device | OAS + BA |
Primary outcome
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.
Mean Maximum Balloon Inflation Pressure
Time frame: Index Procedure
Mean maximum balloon inflation pressure of balloons used pre-stent placement.
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).
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.
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
Stent Usage at the Time of the Index Procedure
Time frame: Index Procedure
Number of lesions with a stent placed during the index procedure.
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26490645Babaev 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 publication: PubMed 27864454Krishnan 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.
- Individual participant dataSharing planned: No. CSI has no plans to share IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anvar Babaev, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stealth 360°® OAS in people with Peripheral Artery Disease and PAD, run by Abbott Medical Devices at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Clinically Driven Target Lesion Revascularization (TLR) (time frame: 6 months and 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01938391, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.