NCT05035771

The IMPACT PAD Study

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Mid and South Essex NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-18
• Primary completion: 2024-10-06
• Completion: 2024-10-06
• First posted: 2021-09-05
• Last updated: 2024-01-12

Locations

1 site across 1 country: United Kingdom