Peripheral Arterial DiseaseNCT04793581
Assessment of the Utility of the Pantheris Small Vessel (SV) System
A study testing Atherectomy in people with Peripheral Arterial Disease, run by Avinger, Inc. at 2 sites in United States.
Trial summary
A single-arm study to assess the utility of the Pantheris SV catheter in addressing peripheral artery disease in arteries located below the knee. Data will be collected on the percent stenosis pre- and post-atherectomy and then symptoms and adverse events noted at 30 days, 6 months, and 1 year after the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Atherectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jan 2021to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18 years or older
- Target lesion in the infragenicular segment
- At least 1 pedal vessel noted in the foot
- Rutherford classification 3 to 6
- Willing to give informed consent
Who cannot join
- if female, is pregnant or breast feeding
- has had surgery or endovascular procedure within 30 days prior to the index procedure
- has planned surgery within 30 days after the index procedure
- had a major bleeding event within 60 days prior to the index procedure
- currently in the treatment phase of a drug or device trial
- has anticipated life span of less than 1.5 years
- is unwilling to present to the investigator at 30 days, 6 moths, or 1 year after the index procedure
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Advanced Cardiac and Vascular Centers
Grand Rapids, Michigan, 49525
Abby Mize, BS, 616-447-8220, amize@acvcenters.com
Jihad Mustapha, MD
- Recruiting
Eastlake Cardiovascular PC
Saint Clair Shores, Michigan, 48080
Rewaa Yas, MS, 586-944-2800 ext. 522, ryas@eastlakecv.com
Thomas Davis, MD
About this study
Official title: Assessment of the Utility of the Pantheris SV System
A single-arm study to assess the utility of the Pantheris SV catheter in addressing peripheral artery disease in arteries located below the knee. Data will be collected on the percent stenosis pre- and post-atherectomy and then symptoms and adverse events noted at 30 days, 6 months, and 1 year after the procedure.
Read the detailed description
This is a post-market, single-arm study of the optical coherence tomography (OCT)-guided directional atherectomy catheter, Pantheris SV. Patients presenting with reduced blood flow in the lower extremity arteries will under directional atherectomy, followed by adjunctive therapy as deemed necessary by the physician, and then adverse events and symptom resolution will be documented at 30 days, 6 months, and 1 year after the procedure. Primary safety endpoints are related to adverse events and will be assessed at the time of the procedure and at 30 days after the procedure. Effectiveness endpoints center on restoration of blood flow.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Atherectomy
- Keywords
- peripheral artery disease (PAD) below-the-knee atherectomy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtherectomyDevice
Directional atherectomy of lesions below the knee.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Single-arm study Receives: Device: Atherectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Events
freedom from cardiovascular-related events
Measured: from procedure to 30 days post-procedure
Technical success
defined as residual stenosis < 50 percent after atherectomy
Measured: At 1 day post-procedure
Secondary outcomes (5)
Procedure success
defined as residual stenosis < 30 percent post adjunctive therapy
Measured: At 1 day post-procedure
Freedom from target vessel revascularization (TVR)
revascularization needed further
Measured: At 6 and 12 months post-procedure
Primary patency
change in peak systolic velocity ratio (PSVR)
Measured: At 6 and 12 months post-procedure
Ankle-Brachial Index (ABI)
change since index procedure
Measured: At 6 and 12 months post-procedure
Rutherford Classificaiton
Change since index procedure
Measured: At 30 days, 6 months, and 1 year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start29 Jan 2021
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- 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
- Model description
- Single-arm
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avinger, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaafer Golzar, MD, Study chair, Avinger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793581
- Sponsor's protocol ID
- IMAGE BTK
- Status last verified
- Jul 2024
- First submitted
- 29 Jan 2021
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Khalili H, Jeon-Slaughter H, Armstrong EJ, Baskar A, Tejani I, Shammas NW, Prasad A, Abu-Fadel M, Brilakis ES, Banerjee S. Atherectomy in below-the-knee endovascular interventions: One-year outcomes from the XLPAD registry. Catheter Cardiovasc Interv. 2019 Feb 15;93(3):488-493. doi: 10.1002/ccd.27897. Epub 2018 Nov 30.
PubMed 30499198Schwindt AG, Bennett JG Jr, Crowder WH, Dohad S, Janzer SF, George JC, Tedder B, Davis TP, Cawich IM, Gammon RS, Muck PE, Pigott JP, Dishmon DA, Lopez LA, Golzar JA, Chamberlin JR, Moulton MJ, Zakir RM, Kaki AK, Fishbein GJ, McDaniel HB, Hezi-Yamit A, Simpson JB, Desai A. Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study. J Endovasc Ther. 2017 Jun;24(3):355-366. doi: 10.1177/1526602817701720. Epub 2017 Apr 10.
PubMed 28393673
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Utility of the Pantheris SV System
- ClinicalTrials.gov ID
- NCT04793581
- Acronym / sponsor ID
- IMAGE BTK
- Conditions
- Peripheral Arterial Disease
- Keywords
- peripheral artery disease (PAD) below-the-knee atherectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Avinger, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-arm study to assess the utility of the Pantheris SV catheter in addressing peripheral artery disease in arteries located below the knee. Data will be collected on the percent stenosis pre- and post-atherectomy and then symptoms and adverse events noted at 30 days, 6 months, and 1 year after the procedure.
Detailed description
This is a post-market, single-arm study of the optical coherence tomography (OCT)-guided directional atherectomy catheter, Pantheris SV. Patients presenting with reduced blood flow in the lower extremity arteries will under directional atherectomy, followed by adjunctive therapy as deemed necessary by the physician, and then adverse events and symptom resolution will be documented at 30 days, 6 months, and 1 year after the procedure. Primary safety endpoints are related to adverse events and will be assessed at the time of the procedure and at 30 days after the procedure. Effectiveness endpoints center on restoration of blood flow.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: AtherectomySingle-arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- Target lesion in the infragenicular segment
- At least 1 pedal vessel noted in the foot
- Rutherford classification 3 to 6
- Willing to give informed consent
Key exclusion criteria (7 listed)
- if female, is pregnant or breast feeding
- has had surgery or endovascular procedure within 30 days prior to the index procedure
- has planned surgery within 30 days after the index procedure
- had a major bleeding event within 60 days prior to the index procedure
- currently in the treatment phase of a drug or device trial
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 |
|---|---|---|
| AtherectomyDirectional atherectomy of lesions below the knee. | Device | Single Arm |
Primary outcome
Major Adverse Events
Time frame: from procedure to 30 days post-procedure
freedom from cardiovascular-related events
Technical success
Time frame: At 1 day post-procedure
defined as residual stenosis < 50 percent after atherectomy
5 secondary outcomes
Procedure success
Time frame: At 1 day post-procedure
Freedom from target vessel revascularization (TVR)
Time frame: At 6 and 12 months post-procedure
Primary patency
Time frame: At 6 and 12 months post-procedure
Ankle-Brachial Index (ABI)
Time frame: At 6 and 12 months post-procedure
Rutherford Classificaiton
Time frame: At 30 days, 6 months, and 1 year post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Results publication: PubMed 30499198Khalili H, Jeon-Slaughter H, Armstrong EJ, Baskar A, Tejani I, Shammas NW, Prasad A, Abu-Fadel M, Brilakis ES, Banerjee S. Atherectomy in below-the-knee endovascular interventions: One-year outcomes from the XLPAD registry. Catheter Cardiovasc Interv. 2019 Feb 15;93(3):488-493. doi: 10.1002/ccd.27897. Epub 2018 Nov 30.
- Results publication: PubMed 28393673Schwindt AG, Bennett JG Jr, Crowder WH, Dohad S, Janzer SF, George JC, Tedder B, Davis TP, Cawich IM, Gammon RS, Muck PE, Pigott JP, Dishmon DA, Lopez LA, Golzar JA, Chamberlin JR, Moulton MJ, Zakir RM, Kaki AK, Fishbein GJ, McDaniel HB, Hezi-Yamit A, Simpson JB, Desai A. Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study. J Endovasc Ther. 2017 Jun;24(3):355-366. doi: 10.1177/1526602817701720. Epub 2017 Apr 10.
- Individual participant dataSharing planned: No
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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.
Jaafer Golzar, MD study chair
Avinger, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atherectomy in people with Peripheral Arterial Disease, run by Avinger, Inc. at 2 sites 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 5 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Lawson, PhD (6502417030, tlawson@avinger.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Events (time frame: from procedure to 30 days post-procedure). The study lists 2 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 NCT04793581, 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 30 Jul 2024.