NCT01937351

Brief Summary

A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an atherectomy device that provides directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque in diseased lower extremity arteries.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
2 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

May 12, 2017

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

2.1 years

First QC Date

September 4, 2013

Results QC Date

April 5, 2017

Last Update Submit

March 3, 2021

Conditions

Peripheral Arterial Disease

Keywords

AtherectomyOptical Coherence TomographyLumivascular

Outcome Measures

Primary Outcomes (2)

  • Primary Safety Endpoint

    The primary safety endpoint is defined as freedom from a composite of major adverse events (MAE) through 6-Month follow-up as adjudicated by an independent Clinical Events Committee (CEC). Individual MAEs include: 1. Cardiovascular related death 2. Unplanned, major index limb amputation 3. Clinically driven target lesion revascularization (TLR) 4. Myocardial infarction 5. Device related events: 1. Clinically significant perforation 2. Clinically significant dissection 3. Clinically significant embolus 4. Pseudoaneurysm

    Day 0 through 6 Months

  • Primary Effectiveness Endpoint: Technical Success

    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 (12)

  • Secondary Safety Endpoint

    Day 0 through Day 30

  • Secondary Safety Endpoint

    Day 0 through 30 days

  • Secondary Safety Endpoint

    Day 0 through 6 Months

  • Secondary Effectiveness Endpoint: Procedural Success

    Day 0

  • Secondary Effectiveness Endpoint: ABI

    Day 30

  • +7 more secondary outcomes

Study Arms (1)

Pantheris Treatment Arm

EXPERIMENTAL

Intervention: Atherectomy using the Pantheris system.

Device: Pantheris System

Interventions

Pantheris SystemDEVICE

Atherectomy using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries.

Pantheris Treatment Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old;
  • Subject is a candidate for percutaneous intervention for peripheral arterial disease in the legs;
  • Subject is willing and able to give informed consent;
  • Documented symptomatic atherosclerotic peripheral arterial disease Rutherford Classification 2-5;
  • Reference vessel lumen proximal to target lesion ≥ 2.5 mm and ≤ 7.0 mm in diameter by visual estimation;
  • Subject has de novo target lesion(s) with stenosis \>70% by visual estimation distal to the profunda femoral artery. No more than 2 lesions may be treated with the Pantheris device;
  • Target lesion length ≤ 15 cm (may be two tandem lesions that do not exceed 15cm in total length);
  • Subject is capable of meeting requirements and be present at the follow-up clinic visits at 30 days and 6 months;
  • At least one patent tibial run-off vessel at baseline.
  • Completed the 6-month follow-up visit
  • Re-consented prior to the 24-month follow-up visit

You may not qualify if:

  • Subject is pregnant or breast feeding;
  • Rutherford Class 0 to 1 (asymptomatic and mild claudication);
  • Rutherford Class 6 (critical limb ischemia);
  • Moderate to severe calcification of the target lesion;
  • Acute ischemia and/or acute thrombosis of the Superficial Femoral Artery (SFA)-Popliteal segment;
  • In-stent restenosis within the target lesion;
  • Target lesion with any type of stent or graft;
  • Target lesion in the iliac artery;
  • Target lesion stenosis \<70%;
  • Subjects with significant (≥70%) occlusive lesions proximal to the target lesion not successfully treated during the index procedure (upstream disease) and prior to treatment of the target lesion;
  • 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;
  • Subjects with active systemic infections whether they are being currently treated or not;
  • Subjects on chronic hemodialysis or creatinine level \>2.0mg/dL;
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

St. Bernard's Medical Center

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Cedars Sinai Medical Center/Cardiovascular Research Foundation of Southern California

West Hollywood, California, 90048, United States

Location

Medstar Washington Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Coastal Vascular and Interventional

Pensacola, Florida, 32501, United States

Location

Alexian Brothers Medical Center, Cardiovascular Associates

Elk Grove Village, Illinois, 60007, United States

Location

Advocate Christ Hospital and Medical Center

Oak Lawn, Illinois, 60453, United States

Location

St. Joseph's Hospital

Fort Wayne, Indiana, 46802, United States

Location

Detroit Medical Center Cardiovascular Institute Harper-Hutzel Hospital

Detroit, Michigan, 48201, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

St. Dominic Hospital

Jackson, Mississippi, 39216, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

St. Peters University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Hatton Institute for Research and Education, Good Samaritan Hospital - Bethesda North

Cincinnati, Ohio, 45220, United States

Location

Dayton Heart Center/Good Samaritan Hospital

Dayton, Ohio, 45414, United States

Location

Jobst Vascular Center

Toledo, Ohio, 43606, United States

Location

Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Methodist Hospital

Memphis, Tennessee, 38116, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

Muenster Hospital

Münster, 48145, Germany

Location

Related Publications (1)

  • Schwindt AG, Bennett JG Jr, Crowder WH, Dohad S, Janzer SF, George JC, Tedder B, Davis TP, Cawich IM, Gammon RS, Muck PE, Pigott JP, Dishmon DA, Lopez LA, Golzar JA, Chamberlin JR, Moulton MJ, Zakir RM, Kaki AK, Fishbein GJ, McDaniel HB, Hezi-Yamit A, Simpson JB, Desai A. Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study. J Endovasc Ther. 2017 Jun;24(3):355-366. doi: 10.1177/1526602817701720. Epub 2017 Apr 10.

    PMID: 28393673DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Results Point of Contact

Title
Thomas Lawson
Organization
Avinger
tlawson@avinger.com
650.241.7030

Study Officials

  • Gray Bennett, MD

    Jackson Heart Clinic

    PRINCIPAL INVESTIGATOR

  • Billy Crowder, MD

    Jackson Heart Clinic

    PRINCIPAL INVESTIGATOR

  • Arne Schwindt, MD

    Muenster Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

September 4, 2013

First Posted

September 9, 2013

Study Start

June 25, 2013

Primary Completion

July 15, 2015

Study Completion

September 20, 2015

Last Updated

March 25, 2021

Results First Posted

May 12, 2017

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(20)DE(1)