Non-invasive Flow Measurements in Patients With Lower Ext... | NCT05689190

Studies
Non-invasive Flow Measurements in Patients With Lower Extremity Arterial Disease (LEAD)

NCT05689190

Sponsor

Philips Clinical & Medical Affairs Global

Status

Terminated

Last Update Posted

May 13, 2026Actual

Enrollment

29Actual

Phase

Not provided

Conditions

Lower Extremity Arterial Disease

Interventions

Not provided

Countries

Netherlands

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 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was terminated early due to slower-than-anticipated participant enrollment. There were no safety concerns.

Expanded Access Info

Start Date

Apr 25, 2023Actual

Primary Completion Date

Feb 25, 2026Actual

Completion Date

Feb 25, 2026Actual

First Submitted Date

Jan 9, 2023

First Submission Date that Met QC Criteria

Jan 9, 2023

First Posted Date

Jan 19, 2023Actual

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 8, 2026

Last Update Posted Date

May 13, 2026Actual

Name	Class
Leiden University Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This concerns a study with patients who will undergo endovascular treatment. Blood flow will be measured by 2D Duplex Ultrasound. Contrast data will be collected that will be processed offline.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Label	Type	Description	Intervention Names
patients		Duplex ultrasound, angiogram, PTA intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
blood flow	Repeatability and correlation of angiographic hemodynamic measurements compared with the golden standard 2D duplex ultrasound.	performed during a regular PTA intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients referred to the vascular surgery outpatient clinic (LUMC) with PAD
Age ≥18 years
Superficial femoral artery (SFA) stenosis (>70% occluded)
Elective for a percutaneous transluminal angioplasty procedure
Written informed consent

Exclusion Criteria:

Contraindications to angiography, such as severe renal insufficiency (eGFR< 20)
Non-correctable bleeding disorder.

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

A total of 30 patients that are referred to the Vascular Surgery outpatient clinic (department of Vascular Surgery) with PAD and an indication for a percutaneous transluminal angioplasty.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carla SP van Rijswijk	Leiden University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leiden University Medical Center		Leiden			Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided