NCT02780349

Brief Summary

Demonstrate the safety and performance of the WIRION™ EPS in subjects undergoing lower extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)

Trial Health

90
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
2 countries

10 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

May 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
5 months until next milestone

Results Posted

Study results publicly available

February 14, 2018

Completed
Last Updated

March 15, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

May 19, 2016

Results QC Date

January 18, 2018

Last Update Submit

February 19, 2018

Conditions

Peripheral Arterial Disease (PAD)

Outcome Measures

Primary Outcomes (1)

  • Freedom From Major Adverse Events (MAE) to 30 Days Post Procedure.

    MAE defined as a serious adverse event that results in death, acute myocardial infarction, thrombosis, pseudo-aneurysm, dissection (grade C or greater) or clinical perforation at the filter location, distal embolism (clinically relevant), unplanned amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC)

    30 days

Study Arms (1)

WIRION EPS

EXPERIMENTAL

Single arm study. All patients undergo procedure with the WIRION EPS

Device: WIRION

Interventions

WIRIONDEVICE

Embolic Protection System

WIRION EPS

Eligibility Criteria

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

You may qualify if:

  • Subject is at least 18 years of age
  • Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures
  • Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations
  • Rutherford classification 2-4
  • Has moderate to severe calcification visualized on angiogram in the femoropopliteal arteries
  • Planned atherectomy of the native femoropopliteal arteries
  • Reference vessel diameter for intended filter location must be visually estimated to be ≥3.5mm and ≤6.0mm
  • An adequate "landing zone" for placement of the WIRION™ device distal to the target lesion of at least 30mm
  • A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days and agrees to remain on birth control throughout the study

You may not qualify if:

  • Any planned surgical or endovascular intervention within 30 days before or after the index procedure
  • A lesion deemed not accessible by the WIRION™ EPS
  • Inability to take aspirin or ADP receptor antagonists
  • History of bleeding diathesis or coagulopathy or will refuse blood transfusion if deemed necessary
  • Has perforation, dissection, or other injury of the access or target vessel requiring additional stenting or surgical intervention before enrollment
  • Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint (participating in registry studies is not excluded)
  • Life expectancy less than 12 months
  • Known severe renal insufficiency (eGFR \<30 ml/min/1.72m2).
  • ≤1-vessel tibial run-off status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Denver VA Medical Center

Denver, Colorado, 80220, United States

Location

Unity Point

Davenport, Iowa, United States

Location

Ochsner Clinic

New Orleans, Louisiana, United States

Location

St Elizabeth Medical Center

Boston, Massachusetts, 02135, United States

Location

St John Hospital

Detroit, Michigan, 48236, United States

Location

Columbia Presbyterian

New York, New York, United States

Location

Lankenau Institute for Medical Research

Philadelphia, Pennsylvania, 19096, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Universitats herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Universitatklinikum Leipzig

Leipzig, 04103, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Results Point of Contact

Title
Vardit Segal Ph.D
Organization
Gardia Medical
vardit@gardiamedical.com
972-4-6277166

Study Officials

  • William Gray, MD

    Main Line Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

May 19, 2016

First Posted

May 23, 2016

Study Start

May 1, 2016

Primary Completion

August 30, 2017

Study Completion

September 30, 2017

Last Updated

March 15, 2018

Results First Posted

February 14, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)US(8)