FLEX Arteriovenous Access Registry | NCT04070365

Studies
FLEX Arteriovenous Access Registry

NCT04070365

Sponsor

VentureMed Group Inc.

Status

Completed

Last Update Posted

May 31, 2022Actual

Enrollment

114Actual

Phase

Not provided

Conditions

Peripheral Artery Disease
Arteriovenous Fistula Stenosis
Arteriovenous Graft Stenosis

Interventions

FLEX Vessel Prep System followed by angioplasty

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 28, 2018Actual

Primary Completion Date

Jun 9, 2021Actual

Completion Date

May 26, 2022Actual

First Submitted Date

Aug 23, 2019

First Submission Date that Met QC Criteria

Aug 23, 2019

First Posted Date

Aug 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2022

Last Update Posted Date

May 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

114Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FLEX Vessel Prep followed by angioplasty			Device: FLEX Vessel Prep System followed by angioplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FLEX Vessel Prep System followed by angioplasty	Device	Eligible Arteriovenous Fistula (AVF)/Arteriovenous Graft (AVG) will be treated with the FLEX Vessel Prep system followed by angioplasty.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anatomic Success	Defined as the angiographic percentage of stenosis post procedure as <30%	At the completion of the index procedure

Secondary Outcomes

Measure	Description	Time Frame
Technical Success of the Device	Delivery to the target lesion, deployment of the treatment element, and retrieval	At the index procedure
Clinical Success	The resumption of normal dialysis for at least one session.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hemodialysis patient currently scheduled to undergo an intervention of their arteriovenous fistula or graft due to clinical or hemodynamic abnormalities.
The patient is ≥18 years of age. Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the inform consent form.
The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
The patient understands the study and is willing and able to comply with follow-up requirements.
The patient is willing to provide informed consent.

Exclusion Criteria:

The patient has a known or suspected systemic infection.
The patient has a known or suspected infection of the hemodialysis graft.
The patient has an untreatable allergy to radiographic contrast material.
In the opinion of the operating physician, the patient's hemodialysis access is unsuitable for endovascular treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with Arteriovenous Fistula or Arteriovenous Graft Stenosis, eligible for FLEX/Angioplasty treatment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Aruny, MD	Dialysis Access Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Grandview Medical Center		Birmingham	Alabama	35243	United States
Flowers Hospital

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000800	Angioplasty, Balloon

Ancestor Terms

ID	Term
D017130	Angioplasty
D002404	Catheterization
D013812	Therapeutics
D057510	Endovascular Procedures

Browse Leaves

Not provided

Browse Branches

Not provided