Peripheral Arterial DiseaseIMPACT PADNCT05035771
The IMPACT PAD Study
A study testing Pressure wire measurement in peripheral vascular disease in people with Peripheral Arterial Disease, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Defining the role of intraprocedural physiology measurements in peripheral endovascular treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Pressure wire measurement in peripheral vascular disease
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Mar 2023to 6 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age
- Peripheral arterial stenosis scheduled for endovascular treatment
Who cannot join
- < 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Essex Cardiothoracic Centre
Basildon, Essex, SS16 5NL
Thomas Keeble, MRCP PhD, 01268 524900, thomas.keeble2@nhs.net
Sarosh Khan, MRCP, 01268 524900 ext. 4211, sarosh.khan2@nhs.net
About this study
Official title: A Safety and Feasibility Study of Intraprocedural Physiology Measurements During Peripheral Endovascular Treatment
Defining the role of intraprocedural physiology measurements in peripheral endovascular treatment
Read the 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
- Being tested
- Pressure wire measurement in peripheral vascular disease
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure wire measurement in peripheral vascular diseaseDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pressure wire measurements | Experimental | Not described Receives: Device: Pressure wire measurement in peripheral vascular disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure wire measurements
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start18 Mar 2023
- Primary completion6 Oct 2024 (estimated)
- Study completion6 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ankur Thapar, MBBS, Principal investigator, Mid and South Essex NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035771
- Sponsor's protocol ID
- Essex CTC IMPACT PAD
- Acronym
- IMPACT PAD
- Status last verified
- Jan 2024
- First submitted
- 21 Jun 2021
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Feasibility Study of Intraprocedural Physiology Measurements During Peripheral Endovascular Treatment
- ClinicalTrials.gov ID
- NCT05035771
- Acronym / sponsor ID
- IMPACT PAD / Essex CTC IMPACT PAD
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Study start
- 18 Mar 2023 (actual)
- Primary completion
- 6 Oct 2024 (estimated)
- Study completion
- 6 Oct 2024 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pressure wire measurements | Experimental | Device: Pressure wire measurement in peripheral vascular disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age
- Peripheral arterial stenosis scheduled for endovascular treatment
Key exclusion criteria (13 listed)
- < 18 year of age
- Unable to give informed consent
- Estimated GFR ≤30 mL/min
- Dialysis dependent
- Unable to receive antiplatelets or periprocedural anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure wire measurement in peripheral vascular diseaseThe 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. | Device | Pressure wire measurements |
Primary outcome
Pressure wire measurements
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ankur Thapar, MBBS principal investigator
Mid and South Essex NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure wire measurement in peripheral vascular disease in people with Peripheral Arterial Disease, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ankur Thapar, MBBS, FRCS (+44 7393 743 954, a.thapar09@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure wire measurements (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.