Peripheral Arterial DiseaseINSIGHTNCT03192696
Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries
A study testing Atherectomy Catheter in people with Peripheral Arterial Disease, run by Avinger, Inc. at 12 sites in United States.
Trial summary
A prospective, non-randomized, international, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy in In-Stent Restenotic (ISR) lesions in 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?
- Atherectomy Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 12 sitesUnited States
- Study dates
- 19 Oct 2017to 1 Dec 2021
- 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
- Subject is >18 years old;
- Subject is willing and able to give informed consent;
- Subject has Rutherford Classification of I-V;
- Subject presenting with a single Class I, II or III ISR lesion as per Tosaka's Classification criteria in the lower leg extremities;
- Target lesion must be >70% stenosed and within a stented segment by angiographic visual estimation;
- Reference vessel lumen acceptable for treatment with Pantheris catheter size as per visual angiographic estimation;
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- Target lesions must be within the stented segment and no more than 3 cm past the proximal or distal portions of the stent;
- Target lesion is ≤30 cm in length;
- Intraluminal crossing of totally occluded lesions prior to atherectomy;
- At least one patent tibial run-off vessel at baseline; and
- Subject is capable of meeting requirements and be present at the follow-up clinic visits at 30 days, 6 months and 12 months.
Who cannot join
- Subject is pregnant or breast feeding;
- Rutherford Class 0 or VI;
- Severe calcification of the target lesion;
- Acute ischemia and/or acute thrombosis of the target lesion segment;
- Target lesion with a covered stent;
- Target lesion in the iliac artery;
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- Target lesion stenosis <70%;
- Target lesion >30 cm in length;
- Subjects with totally occluded stented segments that are not successfully crossed intraluminally prior to atherectomy treatment;
- Grade 4 or 5 stent fracture affecting target stent, or where evidence of stent protrusion into the lumen is noted on angiography in two orthogonal views;
- Subjects on chronic hemodialysis or creatinine level >2.5 mg/dL;
- CVA or stroke within 60 days prior to the index procedure;
- 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;
- Known allergy to contrast agents or medications used to perform endovascular
- intervention that cannot be adequately pre-treated;
- Subjects in whom anti-platelet, aspirin, anticoagulant, or thrombolytic therapy is contraindicated;
- 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 during the index procedure;
- 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; or
- 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
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70809
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
TriHealth-Hatton Research Institute
Cincinnati, Ohio, 45220
University of Missouri
Columbia, Missouri, 65212
Dayton Heart Center
Dayton, Ohio, 45414
St. Bernards Medical Center
Jonesboro, Arkansas, 72401
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Advocate Christ Hospital and Medical Center
Oak Lawn, Illinois, 60453
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
University of California San Diego (UCSD)
San Diego, California, 92037
Cardiovascular Associates of East Texas
Tyler, Texas, 75701
About this study
Official title: INSIGHT: EvaluatIoN of the PantheriS OCT- ImaGing AtHerectomy SysTem For Treatment of In-Stent Restenosis (ISR) Lesions In Lower Extremity Arteries
A prospective, non-randomized, international, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy in In-Stent Restenotic (ISR) lesions in lower extremity arteries.
Read the detailed description
This is a prospective, global, single-arm, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy of in-stent restenotic (ISR) lesions in lower extremity arteries.
The trial will enroll up to 140 subjects diagnosed with peripheral arterial disease of the lower extremities that have previously been treated with stenting at up to 20 sites. The primary disease must be located in reference vessel diameter of >3.0mm and ≤7.0mm. Trial success is focused on safety, including rates of major adverse events through 30 days as adjudicated by a Clinical Events Committee, and effectiveness, which will be evaluated using technical success defined as the percent of target lesions that have residual diameter stenosis <50% post-treatment with the Pantheris device alone as assessed by Angiographic Core Lab.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Atherectomy Catheter
- 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.
Atherectomy CatheterDevice
Treatment of restenotic lesions within stents previously placed within the artery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Cohort | Experimental | Atherectomy of in-stent restenosis Receives: Device: Atherectomy Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from a composite of major adverse events (MAEs) through 30-day follow-up (safety)
The primary safety endpoint is freedom from a composite of major adverse events (MAEs) through 30-day follow-up, as adjudicated by an independent CEC.
Individual MAEs include:
- Cardiovascular-related death;
- Unplanned, major index limb amputation;
- Clinically driven target lesion revascularization (TLR);
- Myocardial infarction; or
- Device-associated events:
- Clinically significant perforation,
- Clinically significant dissection,
- Clinically significant embolus, or
- Pseudoaneurysm.
Measured: Day 0 through 30 days post treatment procedure
Technical success of Pantheris catheter treatment (efficacy) device
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 (7)
Stent structure freedom from new or worsening stent fracture post Pantheris treatment (safety)
Assess the stent for new or worsening stent fracture per comparative Pantheris OCT evaluation pre- and immediately post-procedure.
Measured: Day 0
Secondary Effectiveness Endpoint - Freedom from TLR
Freedom from TLR at 6 months as assessed by an independent CEC.
Measured: 6 months post treatment procedure
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 - Freedom from TLR
Freedom from TLR at 12 months as assessed by an independent CEC.
Measured: 12 months post treatment procedure
Secondary Effectiveness Endpoint - Ankle-Brachial Index
Ankle-Brachial Index at 30 days, 6 and 12 months
Measured: 30 days, 6 and 12 months post treatment procedure
Secondary Effectiveness Endpoint - Rutherford Classification
Rutherford Classification at 30 days, 6 and 12 months
Measured: 30 days, 6 and 12 months post treatment procedure
Secondary Effectiveness Endpoint - Use Adjunctive Devices
Adjunctive devices (stent placement (bare metal or drug eluting stent), drug eluting balloon or other) utilized during the index procedure.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start19 Oct 2017
- Primary completion1 Jun 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avinger, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Janzer, MD, Principal investigator, Einstein Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192696
- Sponsor's protocol ID
- P0942
- Acronym
- INSIGHT
- Status last verified
- Mar 2023
- First submitted
- 12 Jun 2017
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSIGHT: EvaluatIoN of the PantheriS OCT- ImaGing AtHerectomy SysTem For Treatment of In-Stent Restenosis (ISR) Lesions In Lower Extremity Arteries
- ClinicalTrials.gov ID
- NCT03192696
- Acronym / sponsor ID
- INSIGHT / P0942
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Avinger, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 20 Jun 2017 (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 prospective, non-randomized, international, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy in In-Stent Restenotic (ISR) lesions in lower extremity arteries.
Detailed description
This is a prospective, global, single-arm, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy of in-stent restenotic (ISR) lesions in lower extremity arteries.
The trial will enroll up to 140 subjects diagnosed with peripheral arterial disease of the lower extremities that have previously been treated with stenting at up to 20 sites. The primary disease must be located in reference vessel diameter of >3.0mm and ≤7.0mm. Trial success is focused on safety, including rates of major adverse events through 30 days as adjudicated by a Clinical Events Committee, and effectiveness, which will be evaluated using technical success defined as the percent of target lesions that have 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 |
|---|---|---|
| Treatment Cohort | Experimental | Device: Atherectomy CatheterAtherectomy of in-stent restenosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is >18 years old;
- Subject is willing and able to give informed consent;
- Subject has Rutherford Classification of I-V;
- Subject presenting with a single Class I, II or III ISR lesion as per Tosaka's Classification criteria in the lower leg extremities;
- Target lesion must be >70% stenosed and within a stented segment by angiographic visual estimation;
Key exclusion criteria (25 listed)
- Subject is pregnant or breast feeding;
- Rutherford Class 0 or VI;
- Severe calcification of the target lesion;
- Acute ischemia and/or acute thrombosis of the target lesion segment;
- Target lesion with a covered stent;
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 |
|---|---|---|
| Atherectomy CatheterTreatment of restenotic lesions within stents previously placed within the artery. | Device | Treatment Cohort |
Primary outcome
Freedom from a composite of major adverse events (MAEs) through 30-day follow-up (safety)
Time frame: Day 0 through 30 days post treatment procedure
The primary safety endpoint is freedom from a composite of major adverse events (MAEs) through 30-day follow-up, as adjudicated by an independent CEC. Individual MAEs include: 1. Cardiovascular-related death; 2. Unplanned, major index limb amputation; 3. Clinically driven target lesion revascularization (TLR); 4. Myocardial infarction; or 5. Device-associated events: 1. Clinically significant perforation, 2. Clinically significant dissection, 3. Clinically significant embolus, or 4. Pseudoaneurysm.
Technical success of Pantheris catheter treatment (efficacy) device
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.
7 secondary outcomes
Stent structure freedom from new or worsening stent fracture post Pantheris treatment (safety)
Time frame: Day 0
Secondary Effectiveness Endpoint - Freedom from TLR
Time frame: 6 months post treatment procedure
Secondary Effectiveness Endpoint - Procedural Success
Time frame: Day 0
Secondary Effectiveness Endpoint - Freedom from TLR
Time frame: 12 months post treatment procedure
Secondary Effectiveness Endpoint - Ankle-Brachial Index
Time frame: 30 days, 6 and 12 months post treatment procedure
Secondary Effectiveness Endpoint - Rutherford Classification
Time frame: 30 days, 6 and 12 months post treatment procedure
Secondary Effectiveness Endpoint - Use Adjunctive Devices
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- 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.
Sean Janzer, MD principal investigator
Einstein Medical Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atherectomy Catheter in people with Peripheral Arterial Disease, run by Avinger, Inc. at 12 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 11 inclusion and 25 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 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Freedom from a composite of major adverse events (MAEs) through 30-day follow-up (safety) (time frame: Day 0 through 30 days post treatment 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?
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 28 Mar 2023.