Assessing blood flow during treatment for peripheral artery disease
A Safety and Feasibility Study of Intraprocedural Physiology Measurements During Peripheral Endovascular Treatment
This study tests whether using special pressure measurements during artery treatments can help improve blood flow for people with peripheral artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mid and South Essex NHS Foundation Trust Academic / other |
| Locations | 1 site (Basildon, Essex) |
| Trial ID | NCT05035771 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of using pressure wire measurements during endovascular procedures for patients with peripheral arterial disease. It aims to improve the assessment of blood flow and pressure normalization across arterial lesions, which is currently done only through anatomical imaging. By incorporating these physiological measurements, the study seeks to enhance the quality of interventions for patients suffering from claudication or critical limb threatening ischemia. The research will involve patients scheduled for endovascular treatment and will assess the impact of these measurements on clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with peripheral arterial stenosis scheduled for endovascular treatment.
Not a fit: Patients with severe comorbidities, such as NYHA IV heart failure or those unable to receive anticoagulation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and better management of peripheral arterial disease.
How similar studies have performed: While the use of pressure wire measurements is gaining traction, this specific approach in peripheral arterial disease is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basildon, Essex
- Essex Cardiothoracic Centre — Basildon, Essex, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Ankur Thapar, MBBS — Mid and South Essex NHS Foundation Trust
- Study coordinator: Ankur Thapar, MBBS, FRCS
- Email: a.thapar09@imperial.ac.uk
- Phone: +44 7393 743 954
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.