The IMPACT PAD Study (IMPACT PAD)

January 11, 2024 updated by: Mid and South Essex NHS Foundation Trust

A Safety and Feasibility Study of Intraprocedural Physiology Measurements During Peripheral Endovascular Treatment

Defining the role of intraprocedural physiology measurements in peripheral endovascular treatment

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Endovascular treatment for peripheral arterial disease is commonly performed for claudication or critical limb threatening ischaemia (ischaemic rest pain, foot ulcer or gangrene). Disease is generally identified using Ankle Brachial Pressure Index or Toe Brachial Pressure Index and then lesions delineated using Doppler ultrasound or CT angiography. Clinical severity is staged using absolute walking distance (metres) in claudicants or the Society for Vascular Surgery wIfI (wound, ischaemia, foot infection) score in critical limb threatening ischaemia patients.

Intra-procedural lesion assessment and quality control is currently performed anatomically using angiography alone, with a few centres using pullback pressures across a lesion to give supplementary trans-lesional gradients or intravascular ultrasound (IVUS) to give pre and post intervention diameter and vessel area measurements. No direct or quantitative assessment of flow, or pressure normalisation across lesions is currently performed during interventions to improve blood flow to the leg.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Essex
      • Basildon, Essex, United Kingdom, SS16 5NL
        • Recruiting
        • Essex cardiothoracic centre
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • < 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pressure wire measurements
Device: Pressure wire measurement in peripheral vascular disease
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pressure wire measurements
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mid and South Essex NHS Foundation Trust

Investigators

  • Principal Investigator: Ankur Thapar, MBBS, Mid and South Essex NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2023

Primary Completion (Estimated)

October 6, 2024

Study Completion (Estimated)

October 6, 2024

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Essex CTC IMPACT PAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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