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NCT05035771 Clinical Trial

The IMPACT PAD Study

Peripheral Arterial Disease Clinical Trial

— IMPACT PAD  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05035771
Other study ID # Essex CTC IMPACT PAD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 18, 2023
Est. completion date October 6, 2024

Study information
Verified date January 2024
Source Mid and South Essex NHS Foundation Trust
Contact Ankur Thapar, MBBS, FRCS
Phone +44 7393 743 954
Email a.thapar09@imperial.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Defining the role of intraprocedural physiology measurements in peripheral endovascular treatment

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date October 6, 2024
Est. primary completion date October 6, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United Kingdom Essex Cardiothoracic Centre Basildon Essex

Sponsors (1)
Lead Sponsor Collaborator
Mid and South Essex NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pressure wire measurements 12 months
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