Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries

NCT03192696 | Completed FDA Device

• 1 other identifier: P0942
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 12

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• 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: 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

  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 Outcomes (7)

• Stent structure freedom from new or worsening stent fracture post Pantheris treatment (safety)

  Day 0

• Secondary Effectiveness Endpoint - Freedom from TLR

  6 months post treatment procedure

• Secondary Effectiveness Endpoint - Procedural Success

  Day 0

• Secondary Effectiveness Endpoint - Freedom from TLR

  12 months post treatment procedure

• Secondary Effectiveness Endpoint - Ankle-Brachial Index

  30 days, 6 and 12 months post treatment procedure

Study Arms (1)

Treatment Cohort

EXPERIMENTAL

Atherectomy of in-stent restenosis

Device: Atherectomy Catheter

Interventions

Atherectomy Catheter DEVICE

Treatment of restenotic lesions within stents previously placed within the artery.

Treatment Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Avinger, Inc.: lead

Study Sites (12)

St. Bernards Medical Center

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

University of California San Diego (UCSD)

San Diego, California, 92037, United States

Location

Advocate Christ Hospital and Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Baton Rouge General Medical Center

Baton Rouge, Louisiana, 70809, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

TriHealth-Hatton Research Institute

Cincinnati, Ohio, 45220, United States

Location

Dayton Heart Center

Dayton, Ohio, 45414, United States

Location

Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Cardiovascular Associates of East Texas

Tyler, Texas, 75701, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Sean Janzer, MD

  Einstein Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 20, 2017
• Study Start: October 19, 2017
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)