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

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ClinicalTrials.gov Identifier: NCT03192696
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Avinger, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Atherectomy Catheter Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INSIGHT: EvaluatIoN of the PantheriS OCT- ImaGing AtHerectomy SysTem For Treatment of In-Stent Restenosis (ISR) Lesions In Lower Extremity Arteries
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Cohort
Atherectomy of in-stent restenosis
 Device: Atherectomy Catheter
Treatment of restenotic lesions within stents previously placed within the artery.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192696


Contacts
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Contact: Thomas Lawson, PhD 650-241-7930 tlawson@avinger.com
Contact: Thomas Lawson, PhD 650-241-7030 tlawson@avinger.com

Locations
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United States, Arkansas
St. Bernards Medical Center Recruiting
Jonesboro, Arkansas, United States, 72401
Contact: Kayla Rubino, LPN    870-935-6729    krubino@stbheart.com   
Principal Investigator: Barry Tedder, MD         
Arkansas Heart Hospital Completed
Little Rock, Arkansas, United States, 72211
United States, California
University of California San Diego (UCSD) Recruiting
San Diego, California, United States, 92037
Contact: Bahman Ghannadian, MD    858-246-2360    bghannadian@ucsd.edu   
Principal Investigator: Mitul Patel, MD         
United States, Illinois
Advocate Christ Hospital and Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Christopher Doherty, RN    708-684-4618    christopher.doherty@advocatehealth.com   
Principal Investigator: Jaafer Golzar, MD         
United States, Louisiana
Baton Rouge General Medical Center Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Stacie LaPrarie, RN    225-237-1673    Stacie.laprarie@brgeneral.org   
Contact: Jane Byrne    225-237-1674    jane.byrne@brgeneral.org"   
Principal Investigator: Glen Schwartzberg, MD         
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact: Jill Akers, LPN    573-882-0177    akersji@health.missouri.edu   
Principal Investigator: Todd Vogel, MD         
United States, New Jersey
Deborah Heart and Lung Center Recruiting
Browns Mills, New Jersey, United States, 08015
Contact: Linda Dewey, RN    609-893-1200 ext 5023    deweyl@deborah.org   
Principal Investigator: Vincent Varghese, DO         
United States, Ohio
TriHealth-Hatton Research Institute Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Lori Reid, MSN, RN, CCRC    (513)862-5124    lori_reid@trihealth.com   
Principal Investigator: Patrick Muck, MD         
Dayton Heart Center Recruiting
Dayton, Ohio, United States, 45414
Contact: Chris Weller, RN, CCRC    937-276-8784 ext 3187    cweller@premierhealth.com   
Contact: Jeff Gluck, PHS    937-276-8784 ext 3152    jfgluck@premierhealth.com   
Principal Investigator: Gary J. Fishbein, MD, FACC         
United States, Pennsylvania
Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Rachel Murphy    215-456-1959    MurphyRa@einstein.edu   
Contact: Kinnari Murthy, MPH    215-456-6736    MurthyK@einstein.edu   
Principal Investigator: Sean Janzer, MD         
Sub-Investigator: Jon George, MD         
United States, Tennessee
University of Tennessee Health Science Center Recruiting
Memphis, Tennessee, United States, 38163
Contact: Carol Hendrix    901-448-2478    chendri6@uthsc.edu   
Principal Investigator: Dwight Dishmon, MD         
United States, Texas
Cardiovascular Associates of East Texas Recruiting
Tyler, Texas, United States, 75701
Contact: Elizabeth Olson    903-595-2283    eolson@caet.net   
Principal Investigator: Jeffrey Carr, MD         
Sponsors and Collaborators
Avinger, Inc.
Investigators
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Principal Investigator: Sean Janzer, MD Einstein Medical Center
More Information
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Responsible Party: Avinger, Inc.
ClinicalTrials.gov Identifier: NCT03192696    
Other Study ID Numbers: P0942
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases