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Genicular Artery Embolisation for Knee Osteoarthritis II (GENESISII)

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Genicular Artery Embolisation
Genicular Artery Injection
Sponsored by
Varian, a Siemens Healthineers Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Microspheres, Embozene, Artery Embolization, Joint diseases, Osteoarthritis, Knee

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ALL inclusion criteria below need to be fulfilled for the patient to participate in the study.

  • Participant is willing and able to give informed consent for participation in the study.
  • Participants aged 45 years or above.
  • Grade 1-3 knee OA on X-ray as per Kellgren-Lawrence Grading Scale
  • Knee pain for at least 3 months resistant to conservative non-surgical treatment (e.g., physiotherapy, steroid injections, weight loss programs, PRP (platelet-rich plasma) injections)
  • Be able to lie flat for at least 6 hours-this will be assessed by asking how participants sleep (bed, chair recumbent, semi-recumbent) and assessing what prevents them from lying flat overnight (breathlessness, back pain, etc)
  • Minimum score of 50 on baseline 0 - 100 VAS

Exclusion Criteria:

The patient may not enter the study if ANY of the following apply:

  • Rheumatoid arthritis or infectious arthritis
  • Severe knee OA (grade 4 on x-ray as per Kellgren-Lawrence Grade)
  • Renal impairment: eGFR <45. Assessed from medical records or a blood test if required as is part of standard clinical practice when considering a patient for a therapeutic intervention.
  • Patients with a bleeding diathesis, or other bleeding risk such as patients on warfarin which cannot be stopped easily (e.g., patients with metallic heart valves) assessed by asking the patient and from medical records. Uncorrectable bleeding diathesis: INR>1.6, Platelets <50,000
  • Requires oxygen on ambulation. Assessed by asking the patient and from medical records.
  • Low life expectancy (<1 year)
  • Communication difficulty due to language barriers
  • Contraindication to MRI
  • Known allergies to barium sulfate, 3-aminopropyltrialkoxysilane, polyphosphazene or IV radiopaque contrast agent
  • History of Peripheral Arterial Disease (PAD) with intermittent claudication and/or rest pain
  • Pregnancy or positive pregnancy test (the participant will be exposed to ionising radiation during the fluoroscopy procedure)
  • Any other significant disease or disorder which, in the opinion of the recruiting physician, may put the participants at risk because of participation in the study, or may influence the result of the study or the participant's ability to participate

Sites / Locations

  • Royal Berkshire NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

GAE Treatment

Sham Procedure

Arm Description

The genicular artery embolisation procedure identifies abnormal blood vessels in the knee via angiogram imaging. Through groin access and puncture of the femoral artery through a small sheath tiny microspheres (Embozene(TM)) will be injected into this area and reduce blood flow in order to reduce pain.

In the control (sham) arm patients will not undergo the embolisation procedure with microspheres, instead they will have 2ml of saline injected into their knee artery supplying the abnormal area of the knee. The remainder of the procedure is otherwise identical between the two groups.

Outcomes

Primary Outcome Measures

Determine if embolisation of abnormal neovasculature arising from branches of the genicular arteries reduces pain in patients with knee OA compared to Sham treatment
Change from baseline to 6 months post randomisation in the mean score on four Knee Injury and Osteoarthritis Outcome Score subscales, covering pain, symptoms, activities of daily living, and quality of life (KOOS4); scores range from 0 (worst) to 100 (best)

Secondary Outcome Measures

Determine clinical success
The proportion of subjects reporting at least a 10- point improvement in KOOS scores at 6-months (where a 10-point change from baseline is defined as the minimum clinically important difference (MCID)
Assessment of pain relief
Pain relief at 6 months post randomisation, using the patient-reported 0 - 100 visual analogue scale (VAS) pain score
Determine if embolisation improves pain, function, and quality of life in patients with knee OA compared to Sham treatment
All 5 subscales of the KOOS questionnaire will be analysed at 6 months post randomisation.

Full Information

First Posted
April 11, 2022
Last Updated
July 26, 2023
Sponsor
Varian, a Siemens Healthineers Company
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1. Study Identification

Unique Protocol Identification Number
NCT05423587
Brief Title
Genicular Artery Embolisation for Knee Osteoarthritis II
Acronym
GENESISII
Official Title
Genicular artEry embolisatioN in patiEnts With oSteoarthrItiS of the Knee II
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
February 8, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Varian, a Siemens Healthineers Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical study is designed as a double-blind sham controlled randomised trial with the option of sham group crossover to receive the GAE treatment at 6 months after unblinding. This study will determine if embolisation of abnormal neovasculature arising from branches of the genicular arteries reduces pain in patients with knee osteoarthritis. The study patient population will consist of up to 110 subjects with knee pain for at least 3 months that is resistant to conservative treatment measures. Subjects will be treated with knee embolisation or 2 mL of saline in the sham arm. At 6 months, all subjects in the sham arm will be allowed to cross-over and receive the embolisation procedure with a follow-up duration of 18 months. The total planned study duration is 3.5 years.
Detailed Description
This is a single-center, randomised trial to compare patients who receive genicular artery embolisation of the knee with patients who receive a sham procedure with saline injection. The study population will consist of up to 110 subjects with knee pain that is resistant to conservative treatment measures for at least 3 months. Subjects will be followed for 24 months. At 6 months patients will be unblinded and offered an optional crossover to receive the GAE procedure with 18 months follow-up. Alongside a sham surgery placebo arm, a high-quality systematic review of surgical RCTs was used as a suitable benchmark to inform the sample size and power calculation. With a 0-100 scale for the primary endpoint of KOOS4, assuming a 1:1 randomization, a mean difference of 6.4 (i.e., effect size) between GAE and Sham treatments, a common standard deviation of 10 (i.e., a Cohen's D of 0.64), an alpha error of 2-sided 0.05 and a power of 0.85, the 2-arm total sample size the requirement is 88 subjects (44 each arm) by Normal approximation. Allowing for a participant dropout rate of 20%, the enrolment goal is 110 participants, approximately 55 in each study arm. All study subjects will undergo a physical exam and history, a contrast-enhanced knee MRI, blood serum and neuropschological assessment with a functional head MRI to identify potential predictors of treatment success. In the GAE treatment arm subject will undergo a genicular artery embolization with Embozene microspheres (100 micron) (Varian Medical Systems) and the Sham group will receive saline through the transarterial catheter through groin access. Participants will be randomly assigned to have particulate embolisation with 100-micron Embozene particles, or to injection with 2 ml heparinized normal saline (sham arm) At 6 months participants will be unblinded and there will be an open extension period for 6 months, in which participants in the sham arm will be offered GAE. Follow-up visits will be at 1 month, 3 months, 6 months, 12 months and 24 months post randomisation. At these visits subjects will complete the KOOS score, the visual analog scale (VAS) pain score, an analgesia diary, and at specific time points the EQ-5D-3L, and report any new adverse events (AEs).All subjects will undergo a contrast-enhanced knee MRI at baseline and at 6 and 12 months. At 6 months after unblinding the sham group subjects have the option to cross over and receive the GAE treatment with follow-up at 1 month, 3 months, 6 months, 12 months and 18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Microspheres, Embozene, Artery Embolization, Joint diseases, Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single Site, Double Blind Sham Randomized Controlled Trial with Sham subject optional crossover to the treatment arm (GAE) at 6 months post randomization to determine if embolization of abnormal blood vessels arising from branches of the genicular arteries reduces pain in patients with knee osteoarthritis.
Masking
ParticipantCare Provider
Masking Description
A randomization algorithm (hidden and protected) allocates a random number to each of the 110 subjects. The outputs of this algorithm will only be accessible to those who are unrestricted by experimental blinding (operator, radiographer, scrub nurse). For safety reasons the interventional radiologist will be aware of the treatment arm (non-blind).
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GAE Treatment
Arm Type
Experimental
Arm Description
The genicular artery embolisation procedure identifies abnormal blood vessels in the knee via angiogram imaging. Through groin access and puncture of the femoral artery through a small sheath tiny microspheres (Embozene(TM)) will be injected into this area and reduce blood flow in order to reduce pain.
Arm Title
Sham Procedure
Arm Type
Sham Comparator
Arm Description
In the control (sham) arm patients will not undergo the embolisation procedure with microspheres, instead they will have 2ml of saline injected into their knee artery supplying the abnormal area of the knee. The remainder of the procedure is otherwise identical between the two groups.
Intervention Type
Procedure
Intervention Name(s)
Genicular Artery Embolisation
Other Intervention Name(s)
Embozene Microspheres, Embozene
Intervention Description
Transarterial catheter directed embolisation of hypervascularity in patients with mild to moderate knee osteoarthritis
Intervention Type
Procedure
Intervention Name(s)
Genicular Artery Injection
Intervention Description
Transarterial catheter directed injection of normal (0.9%) saline in patients with mild to moderate knee osteoarthritis
Primary Outcome Measure Information:
Title
Determine if embolisation of abnormal neovasculature arising from branches of the genicular arteries reduces pain in patients with knee OA compared to Sham treatment
Description
Change from baseline to 6 months post randomisation in the mean score on four Knee Injury and Osteoarthritis Outcome Score subscales, covering pain, symptoms, activities of daily living, and quality of life (KOOS4); scores range from 0 (worst) to 100 (best)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Determine clinical success
Description
The proportion of subjects reporting at least a 10- point improvement in KOOS scores at 6-months (where a 10-point change from baseline is defined as the minimum clinically important difference (MCID)
Time Frame
6 months
Title
Assessment of pain relief
Description
Pain relief at 6 months post randomisation, using the patient-reported 0 - 100 visual analogue scale (VAS) pain score
Time Frame
6 months
Title
Determine if embolisation improves pain, function, and quality of life in patients with knee OA compared to Sham treatment
Description
All 5 subscales of the KOOS questionnaire will be analysed at 6 months post randomisation.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Determine safety and toxicity
Description
Proportion of subjects experiencing relevant adverse events (as per SIR Adverse Event Classification System) at 6 months post randomisation
Time Frame
6 months follow-up
Title
Determine if improvement of knee osteoarthritis can be described by imaging analysis following GAE vs Sham
Description
Whole Organ Magnetic Resonance Imaging Score (WORMS) for non-invasive assessment of synovial hypertrophy and neo-vascularization for osteoarthritis at 6 months post randomisation.
Time Frame
6 months
Title
Quantification of a personalised psychometric pain profile to determine whether treatment response can be predicted using behavioural indicators of predisposition to central facilitation of pain
Description
Pain Catastrophizing Scale (PCS) patient questionnaire: Score reflects on painful experiences of the patient. Score from 0 (minimum) to 52 (maximum). A higher score means worse outcome
Time Frame
6 months
Title
Determine quality of life changes
Description
Changes in quality of life measured by Euro-Quality of Life-5D-3L (EQ-5D-3L) assessing five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each having three levels (3L): no problems, some problems, extreme problems (labelled 1-3) in a descriptive fashion.
Time Frame
6 months
Title
Assess patient reported acceptability of study treatment
Description
The PROM questionnaire (Patient reported outcome measures) (10 question patient questionnaire) reports scores between 9 (minimum) to 90 (maximum) where a high score is considered worse acceptance (worse outcome)
Time Frame
1 week after treatment
Title
Determine if patient's need for analgesia will be reduced
Description
Change of analgesia intake at 6 months post randomisation.
Time Frame
6 months
Title
Assess durability of GAE
Description
Time to failure, i.e., time to next invasive intervention for those receiving GAE treatment following (a) randomisation, or (b) crossing over to GAE from Sham arm.
Time Frame
24 months
Title
Perform a health economic cost effectiveness analysis of GAE versus other treatment modalities in the moderate knee OA space
Description
Changes in quality of life measured by EuroQoL-5D (EQ-5D-3L) combined with the time assessment to failure (durability of GAE), i.e., time to next invasive intervention for those receiving GAE treatment following (a) randomization, or (b) crossing over to GAE from Sham arm will be assessed together to describe the cost effectiveness.
Time Frame
6 months
Title
Determine if embolisation improves pain, function, and quality of life in patients with knee OA in the treatment group
Description
All 5 subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be analysed at 12 and 24 months post randomisation. Scores range from 0 (minimum, worst) to 100 (maximum, best).
Time Frame
24 months follow-up
Title
Determine quality of life changes in the GAE group at 12 and 24 months
Description
Changes in quality of life measured by Euro-Quality of Life-5D-3L (EQ-5D-3L) assessing five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each having three levels (3L): no problems, some problems, extreme problems (labelled 1-3) at 12 and 24 months post randomisation in a descriptive fashion.
Time Frame
24 months follow-up
Title
Describe imaging outcomes of knee at 12 months in GAE
Description
Whole Organ Magnetic Resonance Imaging Score (WORMS) for non-invasive assessment of synovial hypertrophy and neo-vascularization for osteoarthritis will be evaluated in the GAE group at 12 months post randomisation.
Time Frame
12 months
Title
Determine if patient's need for analgesia will be reduced in the GAE group
Description
Change of analgesia intake at 12 and 24 months post randomisation.
Time Frame
24 months
Title
Assessment of pain relief in the GAE group
Description
Pain relief at 12 and 24 months post randomisation, using the patient-reported 0 - 100 visual analogue scale (VAS) pain score
Time Frame
24 months
Title
Determine if embolisation improves pain, function, and quality of life in patients with knee OA in the treatment group and compare with the Sham group in subjects who do not cross over at 12 and 24 months
Description
All 5 subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS) will be analysed at 12 and 24 months post randomisation in the GAE and Sham group. Scores range from 0 (worst) to 100 (best).
Time Frame
24 Months
Title
Determine quality of life changes in the GAE and sham group
Description
The second part of the Euro-Quality of Life-5D-3L questionnaire consists of a visual analytic scale (VAS) on which the patient rates his / her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health) at 12 and 24 months post randomisation in the GAE group and compare with the Sham group in subjects who do not cross over.
Time Frame
24 months
Title
Determine if patient's need for analgesia will be reduced
Description
Compare changes of analgesia intake at 12 and 24 months post randomisation in the GAE group with the Sham group in subjects who do not cross over.
Time Frame
24 months
Title
Assessment of pain relief
Description
Compare pain relief in the GAE group at 12 and 24 months post randomisation, using the patient-reported 0 - 100 visual analogue scale (VAS) pain score, and compare to the Sham group in subjects who do not cross over.
Time Frame
24 months
Title
Determine if embolisation improves pain, function, and quality of life in patients with knee OA in the Sham crossover group at 1, 3, 6, 12 and 18 months
Description
All 5 subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS) will be analysed at 1,3,6, 12 and 18 months post treatment in the Sham crossover group. Scores range from 0 (worst) to 100 (best).
Time Frame
18 months
Title
Assessment of pain relief in the Sham crossover group
Description
Pain relief at 1,3,6,12 and 18 months post treatment in the Sham crossover group, using the patient-reported 0 - 100 visual analogue scale (VAS) pain score
Time Frame
18 months
Title
Determine if patient's need for analgesia will be reduced in the Sham crossover group
Description
Change of analgesia intake at 1,3,6,12 and 18 months post treatment in the Sham crossover group.
Time Frame
18 months
Title
Determine quality of life changes in the Sham crossover group
Description
Changes in quality of life measured by Euro-Quality of Life-5D-3L (EQ-5D-3L) assessing five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each having three levels (3L): no problems, some problems, extreme problems (labelled 1-3) at 6, 12 and 18 months post treatment in a descriptive fashion.
Time Frame
18 months
Title
Determine if improvement of knee osteoarthritis can be described by imaging analysis in the Sham crossover group following GAE
Description
Whole Organ Magnetic Resonance Imaging Score (WORMS) for non-invasive assessment of synovial hypertrophy and neo-vascularization for osteoarthritis at 6 and 12 months post treatment in the Sham crossover group
Time Frame
12 months
Title
Quantification of mindfulness as part of a personalised psychometric pain profile to determine whether treatment response can be predicted using behavioural indicators of predisposition to central facilitation of pain
Description
Five-Facet Mindfulness Patient Questionnaire (FFMQ): Reporting a score between 15 (minimum) and 75 (maximum). Higher scores are better and indicative of high trait mindfulness.
Time Frame
6 months
Title
Assessment of depressive symptoms as part of a personalised psychometric profile
Description
Patient Health Questionnaire (PHQ-9): Reports a score between 0 (minimum) and 27 (maximum) with higher scores being worse representing high depressive symptoms
Time Frame
6 months
Title
Assessment of patient's psychological flexibility as part of personalised psychometric profile
Description
Pain Interference - Short Form 6b (PROMIS) patient questionnaire: Reports a score between 6 (minimum) and 30 (maximum), with higher scores being worse representing high pain interference
Time Frame
6 months
Title
Assessment of a patient's anxiety as part of a personalised psychometric profile
Description
Generalized Anxiety Disorder (GAD-7) patient questionnaire: reports a score between 0 (minimum) and 21 (maximum). Higher scores are worse representing more severe levels of anxiety.
Time Frame
6 months
Title
Quantification of patient's psychological flexibility as part of a personalised psychometric profile
Description
Committed Action Questionnaire (CAQ-8): Reports a score between 0 (minimum) and 48 (maximum). Higher scores mean better outcome representing high commitment to goals.
Time Frame
6 months
Title
Quantification of a patient's intolerance of uncertainty
Description
Intolerance of Uncertainty Scale - Short Form patient questionnaire: Reports a score between 0 (minimum) and 60 (maximum). Higher scores are worse representing high intolerance of uncertainty.
Time Frame
6 months
Title
Quantification of a patient's sleep quality as part of personalised psychometric profile
Description
Pittsburgh Sleep Quality Index (PSQI) patient questionnaire: Reports a score between 0 (minimum) to 21 (maximum). Higher scores are worse indicating worse sleep quality.
Time Frame
6 months
Title
Assessment of psychological inflexibility in pain as part of a personalised psychometric pain profile to determine whether treatment response can be predicted using behavioural indicators of predisposition to central facilitation of pain
Description
Psychological Inflexibility in Pain Scale (PIPS) patient questionnaire: reports scores between 16 (minimum) to 112 (maximum). Higher scores (worse results) indicate low flexibility in regard to dealing with pain.
Time Frame
6 months
Title
Quantification of the perspective of a participant's viewpoint on pain as part of a personalised psychometric pain profile
Description
Pain Priors Questionnaire
Time Frame
6 months
Title
Behavioural quantification of psychological flexibility to stratify patients who achieve optimal clinical outcomes from the treatment procedure.
Description
Wisconsin Card Sorting Task: reports reaction time measured in milliseconds (lower value is better outcome as better cognitive function)
Time Frame
6 months
Title
Assess functional connectivity between brain regions and investigate the influence of metabolite levels within pain modulatory regions as a neurochemical marker for vulnerability to further chronic pain states.
Description
Functional head MRI
Time Frame
6 months
Title
Assess patient's capacity of central pain modulation
Description
Quantitative sensory testing: Central pain modulation (CPM) measures the degree to which pain at one site inhibits pain at a distal site. The difference between the initial and final rating is taken as a score of the participant's CPM capacity with a range of -10 to 10 with -10 representing a better result with high pain inhibition/modulation.
Time Frame
6 months
Title
Assess patient's intrinsic attention to pain
Description
Intrinsic Attention to Pain (IAP) test measures whether a participant's attention is intrinsically gravitated towards, or away from pain during thermal stimulation with a score range of +2 to -2, with + 2 representing worse results indicating an inability to attentionally disengage from pain.
Time Frame
6 months
Title
Assess patient's capacity of central facilitation of pain
Description
Temporal Summation (TS) test: describes the degree to which pain responses are centrally enhanced by rapid repeated presentation. A score between -10 to 10 is reported with 10 representing high pain summation as a worse result and -10 no pain summation.
Time Frame
6 months
Title
Perception of health by patient in the GAE and sham group
Description
The second part of the Euro-Quality of Life-5D-3L questionnaire consists of a visual analytic scale (VAS) on which the patient rates his / her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Time Frame
6 months
Title
Perception of health by patient in the GAE group
Description
The second part of the Euro-Quality of Life-5D-3L questionnaire consists of a visual analytic scale (VAS) on which the patient rates his / her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Time Frame
24 months follow-up
Title
Perception of health by patient in GAE and sham group at 12 and 24 months
Description
The second part of the Euro-Quality of Life-5D-3L questionnaire consists of a visual analytic scale (VAS) on which the patient rates his / her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health) at 12 and 24 months post randomisation in the GAE group and compare with the Sham group in subjects who do not cross over.
Time Frame
24 months
Title
Perception of health by patient in sham crossover group at 6, 12 and 18 months
Description
The second part of the Euro-Quality of Life-5D-3L questionnaire consists of a visual analytic scale (VAS) on which the patient rates his / her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health) at 6, 12 and 18 months post treatment.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ALL inclusion criteria below need to be fulfilled for the patient to participate in the study. Participant is willing and able to give informed consent for participation in the study. Participants aged 45 years or above. Grade 1-3 knee OA on X-ray as per Kellgren-Lawrence Grading Scale Knee pain for at least 3 months resistant to conservative non-surgical treatment (e.g., physiotherapy, steroid injections, weight loss programs, PRP (platelet-rich plasma) injections) Be able to lie flat for at least 6 hours-this will be assessed by asking how participants sleep (bed, chair recumbent, semi-recumbent) and assessing what prevents them from lying flat overnight (breathlessness, back pain, etc) Minimum score of 50 on baseline 0 - 100 VAS Exclusion Criteria: The patient may not enter the study if ANY of the following apply: Rheumatoid arthritis or infectious arthritis Severe knee OA (grade 4 on x-ray as per Kellgren-Lawrence Grade) Renal impairment: eGFR <45. Assessed from medical records or a blood test if required as is part of standard clinical practice when considering a patient for a therapeutic intervention. Patients with a bleeding diathesis, or other bleeding risk such as patients on warfarin which cannot be stopped easily (e.g., patients with metallic heart valves) assessed by asking the patient and from medical records. Uncorrectable bleeding diathesis: INR>1.6, Platelets <50,000 Requires oxygen on ambulation. Assessed by asking the patient and from medical records. Low life expectancy (<1 year) Communication difficulty due to language barriers Contraindication to MRI Known allergies to barium sulfate, 3-aminopropyltrialkoxysilane, polyphosphazene or IV radiopaque contrast agent History of Peripheral Arterial Disease (PAD) with intermittent claudication and/or rest pain Pregnancy or positive pregnancy test (the participant will be exposed to ionising radiation during the fluoroscopy procedure) Any other significant disease or disorder which, in the opinion of the recruiting physician, may put the participants at risk because of participation in the study, or may influence the result of the study or the participant's ability to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heike S Hausen, MD
Phone
2068903102
Email
Heike.Hausen@varian.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Pietrovito
Phone
+19782908408
Email
Kathleen.Pietrovito@varian.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark W Little, MD
Organizational Affiliation
Royal Berkshire NHS Foundation Trust, Reading, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Berkshire NHS Foundation Trust
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark W Little, MD
Phone
01183225111
Email
Mark.Little@royalberkshire.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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Genicular Artery Embolisation for Knee Osteoarthritis II

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