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

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: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Atherectomy Catheter

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: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Lawson, PhD; Phone Number: 650-241-7930; Email: tlawson@avinger.com
• Study Contact Backup: Name: Thomas Lawson, PhD; Phone Number: 650-241-7030; Email: tlawson@avinger.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, orPseudoaneurysm.	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.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0
Secondary Effectiveness Endpoint - Freedom from TLR	Freedom from TLR at 6 months as assessed by an independent CEC.	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.	Day 0
Secondary Effectiveness Endpoint - Freedom from TLR	Freedom from TLR at 12 months as assessed by an independent CEC.	12 months post treatment procedure
Secondary Effectiveness Endpoint - Ankle-Brachial Index	Ankle-Brachial Index at 30 days, 6 and 12 months	30 days, 6 and 12 months post treatment procedure
Secondary Effectiveness Endpoint - Rutherford Classification	Rutherford Classification at 30 days, 6 and 12 months	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.	Day 0

Collaborators and Investigators

• Sponsor: Avinger, Inc.
• Investigators: Principal Investigator: Sean Janzer, MD, Einstein Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2017
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID 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