The IMPACT PAD Study

Mid and South Essex NHS Foundation Trust

Status: Enrolling

Conditions: Peripheral Arterial Disease

Treatments: Device: Pressure wire measurement in peripheral vascular disease

Study type: Interventional

Funder types: Other

Identifiers

NCT05035771

Essex CTC IMPACT PAD

Details and patient eligibility

About

Defining the role of intraprocedural physiology measurements in peripheral endovascular treatment

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Pressure wire measurements

Experimental group

Treatment:

Device: Pressure wire measurement in peripheral vascular disease