The IMPACT PAD Study

Not Applicable

Recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Device: Pressure wire measurement in peripheral vascular disease

• Registration Number: NCT05035771
• Lead Sponsor: Mid and South Essex NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-08-31
• Study First Posted: 2021-09-05
• Study Start: 2023-03-18
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-10-06
• Study Completion: 2024-10-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pressure wire measurements	Pressure wire measurement in peripheral vascular disease	-

Primary Outcome Measures

Name	Time	Method
Pressure wire measurements	12 months

Trial Locations

Locations (1)

Essex Cardiothoracic Centre; 🇬🇧 Basildon, Essex, United Kingdom