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The IMPACT PAD Study

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05035771
Acronym
IMPACT PAD
Enrollment
20
Registered
2021-09-05
Start date
2023-03-18
Completion date
2024-10-06
Last updated
2024-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Brief summary

Defining the role of intraprocedural physiology measurements in peripheral endovascular 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.

Interventions

DEVICEPressure 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.

Sponsors

Mid and South Essex NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pressure wire measurements12 months

Countries

United Kingdom

Contacts

Primary ContactAnkur Thapar, MBBS, FRCS
a.thapar09@imperial.ac.uk+44 7393 743 954
Backup ContactThomas Keeble, MD
thomas.keeble2@nhs.net01268524900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026