Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries (INSIGHT)

March 27, 2023 updated by: Avinger, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
127

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • St. Bernards Medical Center
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital
    • California
      • San Diego, California, United States, 92037
        • University of California San Diego (UCSD)
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Hospital and Medical Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Baton Rouge General Medical Center
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • TriHealth-Hatton Research Institute
      • Dayton, Ohio, United States, 45414
        • Dayton Heart Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Einstein Medical Center
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee Health Science Center
    • Texas
      • Tyler, Texas, United States, 75701
        • Cardiovascular Associates of East Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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;
  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Cohort
Atherectomy of in-stent restenosis
Device: Atherectomy Catheter
Treatment of restenotic lesions within stents previously placed within the artery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 0 through 30 days post treatment procedure
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.
Day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stent structure freedom from new or worsening stent fracture post Pantheris treatment (safety)
Time Frame: Day 0
Assess the stent for new or worsening stent fracture per comparative Pantheris OCT evaluation pre- and immediately post-procedure.
Day 0
Secondary Effectiveness Endpoint - Freedom from TLR
Time Frame: 6 months post treatment procedure
Freedom from TLR at 6 months as assessed by an independent CEC.
6 months post treatment procedure
Secondary Effectiveness Endpoint - Procedural Success
Time Frame: Day 0
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.
Day 0
Secondary Effectiveness Endpoint - Freedom from TLR
Time Frame: 12 months post treatment procedure
Freedom from TLR at 12 months as assessed by an independent CEC.
12 months post treatment procedure
Secondary Effectiveness Endpoint - Ankle-Brachial Index
Time Frame: 30 days, 6 and 12 months post treatment procedure
Ankle-Brachial Index at 30 days, 6 and 12 months
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
Rutherford Classification at 30 days, 6 and 12 months
30 days, 6 and 12 months post treatment procedure
Secondary Effectiveness Endpoint - Use Adjunctive Devices
Time Frame: Day 0
Adjunctive devices (stent placement (bare metal or drug eluting stent), drug eluting balloon or other) utilized during the index procedure.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Avinger, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sean Janzer, MD, Einstein Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P0942

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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