The IMPACT PAD Study

Sponsor

Mid and South Essex NHS Foundation Trust (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05035771

Collaborator

(none)

Enrollment

Arm

13.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Defining the role of intraprocedural physiology measurements in peripheral endovascular treatment

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Device: Pressure wire measurement in peripheral vascular disease	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Dec 6, 2023

Anticipated Study Completion Date :

Dec 6, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Pressure wire measurements [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mid and South Essex NHS Foundation Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mid and South Essex NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT05035771

Other Study ID Numbers:

Essex CTC IMPACT PAD

First Posted:

Sep 5, 2021

Last Update Posted:

Jul 8, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Arterial Disease

Peripheral Vascular Diseases

Study Results

No Results Posted as of Jul 8, 2022