NCT05035771

Brief Summary

Defining the role of intraprocedural physiology measurements in peripheral endovascular treatment

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 21, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 18, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

June 21, 2021

Last Update Submit

January 11, 2024

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • Pressure wire measurements

    12 months

Study Arms (1)

Pressure wire measurements

EXPERIMENTAL
Device: Pressure wire measurement in peripheral vascular disease

Interventions

Pressure wire measurement in peripheral vascular diseaseDEVICE

The aim of IMPACT PAD is to examine the safety and feasibility of intraprocedural flow, pressure and resistance rate changes to help predict the success of a peripheral endovascular intervention.

Pressure wire measurements

Eligibility Criteria

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

You may qualify if:

  • years of age
  • Peripheral arterial stenosis scheduled for endovascular treatment

You may not qualify if:

  • \< 18 year of age
  • Unable to give informed consent
  • Estimated GFR ≤30 mL/min
  • Dialysis dependent
  • Unable to receive antiplatelets or periprocedural anticoagulation
  • Pregnancy or breastfeeding
  • Contraindication to adenosine (severe asthma or COPD)
  • WIfI ulcer score \<2 (no exposed bone)
  • WIfI infection score \<2 (skin and subcutaneous tissues only)
  • WIfI gangrene score \<3 (limited to digits)
  • COVID-19 positive
  • NYHA IV heart failure
  • Contra-indication to adenosine including arrhythmia, asthma or allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Ankur Thapar, MBBS

    Mid and South Essex NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ankur Thapar, MBBS, FRCS

CONTACT

+44 7393 743 954a.thapar09@imperial.ac.uk

Thomas Keeble, MD

CONTACT

01268524900thomas.keeble2@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2021

First Posted

September 5, 2021

Study Start

March 18, 2023

Primary Completion

October 6, 2024

Study Completion

October 6, 2024

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)