The IMPACT PAD Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-18

Study Completion Date

2024-10-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Defining the role of intraprocedural physiology measurements in peripheral endovascular treatment

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

IN.PACT Global Clinical Study

NCT01609296

Peripheral Arterial Disease

COMPLETED NA

Utility, Safety, and Effectiveness of the Bard LifeStent 5F Vascular Stent System

NCT03071146

Peripheral Arterial Disease Intermittent Claudication

COMPLETED

Cardiovascular Biomarkers in Peripheral Artery Disease.

NCT05757258

Peripheral Artery Disease

UNKNOWN

Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)

NCT02923193

Peripheral Arterial Disease

COMPLETED NA

IN.PACT™ Quality of Life Post-Reimbursement Study

NCT04597307

Obstructive Disease Atherosclerosis of Femoral Artery Atherosclerosis of Popliteal Artery

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pressure wire measurements

Group Type EXPERIMENTAL

Pressure wire measurement in peripheral vascular disease

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No