Peripheral Arterial DiseaseVISIONNCT01937351
Evaluation of the Pantheris Atherectomy System
A study testing Pantheris System in people with Peripheral Arterial Disease, run by Avinger, Inc. at 21 sites in 2 countries.
Trial summary
A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an atherectomy device that provides directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque in diseased lower extremity arteries. 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?
- Pantheris System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 25 Jun 2013to 20 Sep 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
- Age ≥ 18 years old;
- Subject is a candidate for percutaneous intervention for peripheral arterial disease in the legs;
- Subject is willing and able to give informed consent;
- Documented symptomatic atherosclerotic peripheral arterial disease Rutherford Classification 2-5;
- Reference vessel lumen proximal to target lesion ≥ 2.5 mm and ≤ 7.0 mm in diameter by visual estimation;
- Subject has de novo target lesion(s) with stenosis >70% by visual estimation distal to the profunda femoral artery. No more than 2 lesions may be treated with the Pantheris device;
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- Target lesion length ≤ 15 cm (may be two tandem lesions that do not exceed 15cm in total length);
- Subject is capable of meeting requirements and be present at the follow-up clinic visits at 30 days and 6 months;
- At least one patent tibial run-off vessel at baseline.
- Completed the 6-month follow-up visit
- Re-consented prior to the 24-month follow-up visit
Who cannot join
- Subject is pregnant or breast feeding;
- Rutherford Class 0 to 1 (asymptomatic and mild claudication);
- Rutherford Class 6 (critical limb ischemia);
- Moderate to severe calcification of the target lesion;
- Acute ischemia and/or acute thrombosis of the Superficial Femoral Artery (SFA)-Popliteal segment;
- In-stent restenosis within the target lesion;
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- Target lesion with any type of stent or graft;
- Target lesion in the iliac artery;
- Target lesion stenosis <70%;
- Subjects with significant (≥70%) occlusive lesions proximal to the target lesion not successfully treated during the index procedure (upstream disease) and prior to treatment of the target lesion;
- Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure;
- Planned endovascular or surgical procedure 30 days after the index procedure;
- Lesion in the contralateral limb requiring intervention during the index procedure or within 30 days of the index procedure;
- Subjects with active systemic infections whether they are being currently treated or not;
- Subjects on chronic hemodialysis or creatinine level >2.0mg/dL;
- Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months;
- Evidence or history of aneurysmal target vessel within the past 2 months;
- History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days;
- Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated;
- Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated;
- History of heparin-induced thrombocytopenia (HIT);
- Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/mm2, known coagulopathy, or International Normalized Ratio (INR) >1.5;
- Any thrombolytic therapy within 2 weeks of the index procedure;
- Any clinical and/or angiographic complication attributed to the use of another device prior to the insertion of the study device into the subject;
- Subjects or their legal guardians who have not or will not sign the Informed Consent;
- Subjects who are unwilling or unable to comply with the follow-up study requirements;
- Participation in any study of an investigational device, medication, biologic or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of the study.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
Austin Heart
Austin, Texas, 78756
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Hatton Institute for Research and Education, Good Samaritan Hospital - Bethesda North
Cincinnati, Ohio, 45220
Dayton Heart Center/Good Samaritan Hospital
Dayton, Ohio, 45414
Detroit Medical Center Cardiovascular Institute Harper-Hutzel Hospital
Detroit, Michigan, 48201
St. John Hospital and Medical Center
Detroit, Michigan, 48236
Alexian Brothers Medical Center, Cardiovascular Associates
Elk Grove Village, Illinois, 60007
St. Joseph's Hospital
Fort Wayne, Indiana, 46802
St. Dominic Hospital
Jackson, Mississippi, 39216
St. Bernard's Medical Center
Jonesboro, Arkansas, 72401
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Methodist Hospital
Memphis, Tennessee, 38116
St. Peters University Hospital
New Brunswick, New Jersey, 08901
Advocate Christ Hospital and Medical Center
Oak Lawn, Illinois, 60453
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Coastal Vascular and Interventional
Pensacola, Florida, 32501
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Jobst Vascular Center
Toledo, Ohio, 43606
Medstar Washington Hospital
Washington D.C., District of Columbia, 20010
Cedars Sinai Medical Center/Cardiovascular Research Foundation of Southern California
West Hollywood, California, 90048
About this study
Official title: Evaluation of the Pantheris Optical Coherence Tomography Imaging Atherectomy System for Use in the Peripheral Vasculature
A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an atherectomy device that provides directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque in diseased lower extremity arteries.
Read the detailed description
The trial will enroll up to 173 subjects diagnosed with peripheral arterial disease of the lower extremities at up to 20 sites (up to 3 international sites), including 133 Intention to Treat subjects and up to 2 additional Roll-In subjects at each site (up to 40 Roll-In subjects total). The primary disease must be located in reference vessel diameters ≥ 2.5 mm and ≤ 7.0 mm. Trial success is focused on safety including rates of major adverse events through 6 months as adjudicated by a Clinical Events Committee. Effectiveness will be evaluated using technical success, defined as the percent of target lesions that have a residual diameter stenosis <50% post-treatment with the Pantheris device alone as assessed by Angiographic Core Lab.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Pantheris System
- Keywords
- Atherectomy, Optical Coherence Tomography, Lumivascular
- 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.
Pantheris SystemDevice
Atherectomy using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries.
| Study group | Role | What they receive |
|---|---|---|
| Pantheris Treatment Arm | Experimental | Intervention: Atherectomy using the Pantheris system. Receives: Device: Pantheris System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
The primary safety endpoint is defined as freedom from a composite of major adverse events (MAE) through 6-Month follow-up as adjudicated by an independent Clinical Events Committee (CEC). Individual MAEs include:
- Cardiovascular related death
- Unplanned, major index limb amputation
- Clinically driven target lesion revascularization (TLR)
- Myocardial infarction
- Device related events:
- Clinically significant perforation
- Clinically significant dissection
- Clinically significant embolus
- Pseudoaneurysm
Measured: Day 0 through 6 Months
Primary Effectiveness Endpoint: Technical Success
The primary efficacy endpoint of technical success is defined as the percent of target lesions that have a residual diameter stenosis <50% post the Pantheris device alone, as assessed by an independent Angiographic Core Laboratory.
Measured: Day 0
Secondary outcomes (12)
Secondary Safety Endpoint
Freedom from MAEs as defined above, through 30 days (or hospital discharge, whichever is longer) as adjudicated by an independent CEC.
Measured: Day 0 through Day 30
Secondary Safety Endpoint
Freedom from procedural emboli, defined as a change in any visualized runoff vessel (other than vasospasm and dissection) at any time during the procedure.
Measured: Day 0 through 30 days
Secondary Safety Endpoint
Freedom from clinically driven Target Vessel Revascularization (TVR) through 6 months, as adjudicated by an independent CEC.
Measured: Day 0 through 6 Months
Secondary Effectiveness Endpoint: Procedural Success
Procedural success defined as the percent of target lesions that have residual diameter stenosis < 30% post-Pantheris and any other adjunctive therapy, determined by independent Angiographic Core Laboratory.
Measured: Day 0
Secondary Effectiveness Endpoint: ABI
Ankle-Brachial Index (ABI) at 30 days. ABI is the ratio of blood pressure in the lower legs to the blood pressure in the arms. ABI between 0.95 and 1.3 is considered normal (free from significant peripheral artery disease).
Measured: Day 30
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification at 30 days. Rutherford Classification is a commonly used clinical means for describing the degree of peripheral artery disease. Rutherford Classifications range from Class 0: asymptomatic, to Class 6: major tissue loss.
Measured: Day 30
Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
Change in Quality of Life measures between Baseline and 30 days using 12-Item Short Form Survey (SF-12). There are two components of the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).
Measured: Day 30
Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)
Change in Quality of Life measures between Baseline and 30 days using Vascular Quality of Life Questionnaire (VascuQoL). The VascuQoL is a disease-specific questionnaire developed to assess chronic limb ischemia. VascuQol uses a seven-point scale, with 1 representing the worst score and 7 representing the best score.
Measured: Day 30
Secondary Effectiveness Endpoint: ABI
Ankle-Brachial Index (ABI) at 6 months. ABI is the ratio of blood pressure in the lower legs to the blood pressure in the arms. ABI between 0.95 and 1.3 is considered normal (free from significant peripheral artery disease).
Measured: 6 Month
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification at 6 months. Rutherford Classification is a commonly used clinical means for describing the degree of peripheral artery disease. Rutherford Classifications range from Class 0: asymptomatic, to Class 6: major tissue loss.
Measured: 6 Month
Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
Change in Quality of Life measures between Baseline and 6 Months using 12-Item Short Form Survey (SF-12). There are two components of the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).
Measured: 6 Month
Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)
Change in Quality of Life measures between Baseline and 6 months using Vascular Quality of Life Questionnaire (VascuQoL). The VascuQoL is a disease-specific questionnaire developed to assess chronic limb ischemia. VascuQol uses a seven-point scale, with 1 representing the worst score and 7 representing the best score.
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study start25 Jun 2013
- Primary completion15 Jul 2015
- Study completion20 Sep 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 (1)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
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avinger, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gray Bennett, MD, Principal investigator, Jackson Heart ClinicBilly Crowder, MD, Principal investigator, Jackson Heart ClinicArne Schwindt, MD, Principal investigator, Muenster Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937351
- Sponsor's protocol ID
- P0555
- Acronym
- VISION
- Status last verified
- Mar 2021
- First submitted
- 4 Sep 2013
- Last updated
- 25 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Schwindt 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 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pantheris Optical Coherence Tomography Imaging Atherectomy System for Use in the Peripheral Vasculature
- ClinicalTrials.gov ID
- NCT01937351
- Acronym / sponsor ID
- VISION / P0555
- Conditions
- Peripheral Arterial Disease
- Keywords
- Atherectomy, Optical Coherence Tomography, Lumivascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Avinger, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2013 (actual)
- Primary completion
- 15 Jul 2015 (actual)
- Study completion
- 20 Sep 2015 (actual)
- First posted
- 9 Sep 2013 (estimated)
- Results
- Posted 12 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an atherectomy device that provides directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque in diseased lower extremity arteries.
Detailed description
The trial will enroll up to 173 subjects diagnosed with peripheral arterial disease of the lower extremities at up to 20 sites (up to 3 international sites), including 133 Intention to Treat subjects and up to 2 additional Roll-In subjects at each site (up to 40 Roll-In subjects total). The primary disease must be located in reference vessel diameters ≥ 2.5 mm and ≤ 7.0 mm. Trial success is focused on safety including rates of major adverse events through 6 months as adjudicated by a Clinical Events Committee. Effectiveness will be evaluated using technical success, defined as the percent of target lesions that have a residual diameter stenosis <50% post-treatment with the Pantheris device alone as assessed by Angiographic Core Lab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pantheris Treatment Arm | Experimental | Device: Pantheris SystemIntervention: Atherectomy using the Pantheris system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years old;
- Subject is a candidate for percutaneous intervention for peripheral arterial disease in the legs;
- Subject is willing and able to give informed consent;
- Documented symptomatic atherosclerotic peripheral arterial disease Rutherford Classification 2-5;
- Reference vessel lumen proximal to target lesion ≥ 2.5 mm and ≤ 7.0 mm in diameter by visual estimation;
Key exclusion criteria (27 listed)
- Subject is pregnant or breast feeding;
- Rutherford Class 0 to 1 (asymptomatic and mild claudication);
- Rutherford Class 6 (critical limb ischemia);
- Moderate to severe calcification of the target lesion;
- Acute ischemia and/or acute thrombosis of the Superficial Femoral Artery (SFA)-Popliteal segment;
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 |
|---|---|---|
| Pantheris SystemAtherectomy using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries. | Device | Pantheris Treatment Arm |
Primary outcome
Primary Safety Endpoint
Time frame: Day 0 through 6 Months
The primary safety endpoint is defined as freedom from a composite of major adverse events (MAE) through 6-Month follow-up as adjudicated by an independent Clinical Events Committee (CEC). Individual MAEs include: 1. Cardiovascular related death 2. Unplanned, major index limb amputation 3. Clinically driven target lesion revascularization (TLR) 4. Myocardial infarction 5. Device related events: 1. Clinically significant perforation 2. Clinically significant dissection 3. Clinically significant embolus 4. Pseudoaneurysm
Primary Effectiveness Endpoint: Technical Success
Time frame: Day 0
The primary efficacy endpoint of technical success is defined as the percent of target lesions that have a residual diameter stenosis <50% post the Pantheris device alone, as assessed by an independent Angiographic Core Laboratory.
12 secondary outcomes
Secondary Safety Endpoint
Time frame: Day 0 through Day 30
Secondary Safety Endpoint
Time frame: Day 0 through 30 days
Secondary Safety Endpoint
Time frame: Day 0 through 6 Months
Secondary Effectiveness Endpoint: Procedural Success
Time frame: Day 0
Secondary Effectiveness Endpoint: ABI
Time frame: Day 30
Secondary Effectiveness Endpoint: Rutherford Classification
Time frame: Day 30
Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
Time frame: Day 30
Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)
Time frame: Day 30
Secondary Effectiveness Endpoint: ABI
Time frame: 6 Month
Secondary Effectiveness Endpoint: Rutherford Classification
Time frame: 6 Month
Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
Time frame: 6 Month
Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)
Time frame: 6 Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: 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.
Gray Bennett, MD principal investigator
Jackson Heart Clinic
Billy Crowder, MD principal investigator
Jackson Heart Clinic
Arne Schwindt, MD principal investigator
Muenster Hospital
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pantheris System in people with Peripheral Arterial Disease, run by Avinger, Inc. at 21 sites in 2 countries.
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 11 inclusion and 27 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 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Germany. 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 12 May 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?
Primary Safety Endpoint (time frame: Day 0 through 6 Months). 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 NCT01937351, which also lists 1 linked publication.
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 25 Mar 2021.