ArthritisADVENTURENCT07873892
Transarterial Embolization Versus Sham Procedure in Adults With Treatment-Resistant Inflammatory Arthritis of a Single Large Joint
A study testing Transarterial embolization with resorbable gelatin microspheres in people with Arthritis, run by Istituto Ortopedico Rizzoli.
Trial summary
The goal of this clinical trial is to learn whether transarterial embolization (TAE) can relieve pain and improve well-being in adults with inflammatory arthritis that remains active in only one large joint (wrist, elbow, shoulder, ankle, knee or hip) despite anti-inflammatory drugs, joint injections and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- What is being tested?
- Transarterial embolization with resorbable gelatin microspheres
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older.
- Inflammatory monoarthritis of a large joint (wrist, elbow, shoulder, ankle, knee or hip), fulfilling the ASAS classification criteria for peripheral spondyloarthritis, or diagnosed clinically and on imaging by a rheumatologist when of other aetiology.
- Refractoriness to local and pharmacological treatment, defined as failure of both: (a) at least two different non-steroidal anti-inflammatory drugs (NSAIDs) at full dose and for an adequate duration; and (b) at least one intra-articular glucocorticoid injection into the target joint. Patients who have also failed one or more conventional synthetic DMARDs (methotrexate, leflunomide or sulfasalazine) at adequate doses for at least 3 months, and patients with a documented contraindication to starting or continuing systemic immunosuppressive therapy, are also eligible.
- Failure of structured physiotherapy.
- Pain visual analogue scale (VAS) score of 40 mm or more (0-100 mm scale) at baseline.
- Written informed consent.
Who cannot join
- Active inflammatory involvement of more than one joint.
- Contraindications to angiography: allergy to iodinated contrast medium, severe renal impairment (estimated glomerular filtration rate <30 mL/min) or uncorrectable coagulopathy.
- Intra-articular injection into the target joint within the previous 3 months.
- Change in disease-modifying antirheumatic drug (DMARD) therapy within the month before enrollment.
- Pregnancy or breastfeeding.
- Suspected or confirmed current or previous infection of the target joint.
- Known or suspected allergy to porcine gelatin or collagen.
- Inability to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Advancing Discoveries in Vascular Embolization for New Treatments in Rheumatology: a Single-blind, Sham-controlled, Randomized Trial
The goal of this clinical trial is to learn whether transarterial embolization (TAE) can relieve pain and improve well-being in adults with inflammatory arthritis that remains active in only one large joint (wrist, elbow, shoulder, ankle, knee or hip) despite anti-inflammatory drugs, joint injections and physiotherapy. The researchers expect that more people treated with TAE than with a sham (simulated) procedure will reach low pain and a good overall assessment of their health one month after the procedure.
The main questions it aims to answer are:
Read more
- Does TAE increase the proportion of participants who reach low pain and a good overall assessment of their health one month after the procedure, compared with a sham procedure?
- Is TAE safe, and does it improve quality of life and reduce the need for medication over three months?
TAE is a minimally invasive procedure. A thin catheter is guided through an artery in the groin or wrist to the small vessels that feed the inflamed lining of the joint, and tiny resorbable gelatin particles are injected to temporarily reduce the abnormal blood flow that sustains inflammation and pain. Researchers will compare TAE with a sham procedure to find out whether any benefit comes from the embolization itself rather than from the experience of undergoing a procedure.
Participants will:
- Be randomly assigned (like flipping a coin) to TAE or to the sham procedure. Neither the participants nor the doctor who evaluates them will know which procedure they received.
- Undergo the procedure in the angiography room with light sedation. The sham procedure takes place in the same room, with the same team, sedation and duration, but without any puncture of the artery, contrast medium or X-rays.
- Attend visits before the procedure and 1 week, 1 month and 3 months after it, answer questionnaires on pain and quality of life, and keep a diary of symptoms and medicines for 7 days after the procedure.
After 3 months, participants who received the sham procedure will be offered TAE.
Read the detailed description
Background and rationale
Inflammatory arthritis, including rheumatoid arthritis and the spondyloarthritides, may present with or persist as synovitis of a single joint, even in patients at target according to composite disease activity indices. Patients with monoarthritis have been excluded from registration trials of disease-modifying antirheumatic drugs, and when local treatments fail, escalation to systemic immunosuppression exposes them to class-wide risks (such as serious infections) for a benefit limited to one joint. Repeated intra-articular glucocorticoid injections carry cumulative local risks. Transarterial embolization (TAE) is a minimally invasive procedure that occludes the pathological neovessels of the inflamed synovium without systemic immunosuppression. Evidence on musculoskeletal embolization comes mainly from knee osteoarthritis, where sham-controlled trials have shown discordant results and a large response to the procedural context. In inflammatory arthritis, data are limited to case reports and small series. ADVENTURE is, to our knowledge, the first randomized sham-controlled trial of TAE in inflammatory arthritis.
Design
Single-centre, randomized, sham-controlled, parallel-group superiority trial conducted at IRCCS Istituto Ortopedico Rizzoli (IOR), Bologna, Italy. Potential participants are identified in the rheumatology clinics of IOR and of Azienda USL di Bologna, which refers eligible patients to IOR for consent and enrollment. Participants are randomized 1:1 to TAE or sham procedure using a computer-generated sequence stratified by joint site (upper limb: wrist, elbow, shoulder; lower limb: ankle, knee, hip). The procedure is performed within 4 weeks of randomization. Each participant is followed for 3 months, with visits at baseline, 1 week, 1 month and 3 months after the procedure.
Blinding
Participants and the rheumatologist who assesses outcomes are blinded to allocation for the entire 3-month follow-up. The allocation is communicated only to the interventional radiology team, which cannot be blinded, and procedural data are recorded on a separate case report form, stored separately from clinical data until the end of the trial. The protocol title describes the trial as single-blind; because the assessing rheumatologist is also blinded, masking is recorded here as Participant and Outcomes Assessor.
Interventions
Both procedures are performed in the same angiography suite, by the same team, with identical light sedation (midazolam 2 mg intravenously) and local anaesthesia, and last about 60 minutes. TAE is performed through ultrasound-guided femoral or radial arterial access: after superselective angiography of the arteries supplying the target joint, resorbable porcine gelatin microspheres (Nexsphere-F, 100-300 micrometres; CE-marked class III device) are injected until the pathological synovial blush disappears. Embolization is not performed if superselective angiography shows anatomical or vascular contraindications listed in the device instructions for use. In the sham procedure, a peripheral venous line is placed and a superficial subcutaneous puncture is made at the access site corresponding to the target joint, without arterial access; saline is infused and standardized angiographic sequences are displayed on the monitor. No contrast medium or ionizing radiation is administered in the sham arm. After either procedure, participants are observed for 4-5 hours and receive standardized instructions (compressive dressing for 3 days, local ice, paracetamol and, if needed, low-dose NSAIDs as rescue analgesia).
Open-label crossover
After the 3-month visit, participants allocated to sham are offered open-label TAE, with a follow-up visit 1 month after the procedure. These data are analysed separately and do not contribute to the randomized comparison.
Sample size and statistical analysis
Assuming a primary response rate of 60% with TAE and 10% with sham, a two-sided alpha of 0.05, 80% power and 10% loss to follow-up, 30 participants (15 per group) will be enrolled. The primary analysis follows the intention-to-treat principle, with missing data handled by multiple imputation by chained equations; the primary outcome is compared between groups with Fisher's exact test and the difference in proportions is reported with its 95% confidence interval. A per-protocol analysis is performed as sensitivity analysis. Secondary outcomes are analysed with non-parametric or parametric tests as appropriate and with linear mixed models for repeated measures; they are considered exploratory.
Safety monitoring
An independent Data Safety Monitoring Board (a biostatistician, an interventional radiologist and an orthopaedic surgeon) reviews recruitment, data quality, protocol adherence and adverse events before recruitment begins, after the first 10 participants, annually and whenever a relevant serious adverse event occurs. Data are collected in REDCap with automated range and consistency checks.
- Conditions
- Arthritis
- Being tested
- Transarterial embolization with resorbable gelatin microspheres, Sham embolization procedure
- Keywords
- Embolization, Synovitis, Monoarthritis, Inflammatory arthritis, Refractory arthritis, Sham procedure, Interventional radiology, Gelatin microspheres, Large joints
- Medical subject headings
- Arthritis, Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial embolization with resorbable gelatin microspheresDevice
Superselective transarterial embolization of the arteries supplying the inflamed synovium of the target joint, using resorbable porcine gelatin microspheres (100-300 micrometres; CE-marked class III device) injected through a coaxial microcatheter until the pathological blush disappears. Ultrasound-guided femoral or radial access, light sedation with midazolam 2 mg IV and local anaesthesia. Single procedure.
Sham embolization procedureDevice
Simulated embolization procedure in the angiography suite with identical sedation (midazolam 2 mg IV), local anaesthesia and duration as the active procedure. Superficial subcutaneous puncture at the access site without arterial access, saline infusion and display of standardized angiographic sequences. No contrast medium, embolic agent or ionizing radiation. Single procedure.
| Study group | Role | What they receive |
|---|---|---|
| Transarterial embolization | Experimental | Participants undergo transarterial embolization of the target joint in the angiography suite under light sedation (midazolam 2 mg intravenously) and local anaesthesia. Through ultrasound-guided femoral or radial arterial access, a microcatheter is advanced into the arteries supplying the inflamed synovium and resorbable gelatin microspheres (100-300 micrometres) are injected until the pathological blush disappears. The procedure lasts about 60 minutes and is performed within 4 weeks of randomization. Receives: Device: Transarterial embolization with resorbable gelatin microspheres |
| Sham procedure | Sham comparator | Participants undergo a simulated procedure in the same angiography suite, with the same team, identical light sedation (midazolam 2 mg intravenously) and local anaesthesia, and similar duration (about 60 minutes). A superficial subcutaneous puncture is made at the access site corresponding to the target joint, without arterial access; saline is infused and standardized angiographic sequences are displayed on the monitor. No contrast medium, embolic agent or ionizing radiation is administered. After the 3-month visit, participants are offered open-label transarterial embolization. Receives: Device: Sham embolization procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with pain VAS ≤15 mm and Patient Global Assessment ≤20 mm.
The proportion of participants achieving both a pain visual analogue scale (VAS) score <15 mm, referred to the target joint, and a Patient Global Assessment (PGA) of health status <20 mm, both measured on a 0-100 mm scale (higher scores indicate worse status). Thresholds are derived from the pain and patient global components of the minimal disease activity criteria for psoriatic arthritis. The proportion is compared between the transarterial embolization and sham arms by intention to treat.
Measured: 1 month after the procedure.
Secondary outcomes (7)
Change in pain VAS from baseline.
Change from baseline in pain visual analogue scale (VAS), referred to the target joint, on a 0-100 mm scale (higher scores indicate worse pain).
Measured: Baseline, 1 week and 3 months after the procedure.
Change in Patient Global Assessment from baseline.
Change from baseline in Patient Global Assessment (PGA) of health status on a 0-100 mm visual analogue scale (higher scores indicate worse status).
Measured: Baseline, 1 week and 3 months after the procedure.
Health-related quality of life measured with the EQ-5D
EQ-5D index score and EQ-5D visual analogue scale (0-100; higher scores indicate better health).
Measured: Baseline, 1 week, 1 month and 3 months after the procedure.
Health-related quality of life measured with the SF-36.
Short Form-36 Health Survey domain and summary scores (0-100; higher scores indicate better health).
Measured: Baseline, 1 week, 1 month and 3 months after the procedure.
Change in medication use.
Use of systemic medication (conventional synthetic DMARDs, NSAIDs, glucocorticoids) and topical medication, recorded in participant diaries and verified by the rheumatologist at each visit.
Measured: From baseline to 3 months after the procedure.
Incidence of adverse events.
Number of participants with procedural and post-procedural adverse events, with type and severity, coded with MedDRA and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: From the procedure to 3 months after the procedure.
Patient satisfaction and willingness to repeat the procedure.
Satisfaction with the procedure and willingness to repeat it, each rated on a 5-point Likert scale (1-5; higher scores indicate greater satisfaction).
Measured: 1 month and 3 months after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms randomized 1:1 (TAE vs sham procedure), stratified by joint site (upper vs lower limb). After the 3-month randomized phase, participants in the sham arm are offered open-label TAE; these data are analysed separately and do not contribute to the randomized comparison.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- AUSL Bologna
- Responsible party
- Sponsor
- Investigators
- Jacopo Ciaffi, MD, PhD, Principal investigator, IRCCS Istituto Ortopedico Rizzoli, Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873892
- Sponsor's protocol ID
- ADVENTURE
- Other IDs
- GR-2024-12380060
- Acronym
- ADVENTURE
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The informed consent approved by the ethics committee restricts access to participant data to the sponsor, the investigators, the ethics committee and regulatory authorities, and provides for dissemination of results in aggregate form only. Aggregate results will be published in peer-reviewed journals.
Publications
Ursini F, Ciaffi J, Peta G, Faldini C, Facchini G. Transarterial Embolization for Refractory Ankle Synovitis in an Adult Patient With a History of Juvenile Idiopathic Arthritis. ACR Open Rheumatol. 2025 Dec;7(12):e70141. doi: 10.1002/acr2.70141.
PubMed 41307394Landers S, Hely R, Hely A, Harrison B, Page RS, Maister N, Gwini SM, Gill SD. Genicular artery embolization for early-stage knee osteoarthritis: results from a triple-blind single-centre randomized controlled trial. Bone Jt Open. 2023 Mar 10;4(3):158-167. doi: 10.1302/2633-1462.43.BJO-2022-0161.R2.
PubMed 37051829van Zadelhoff TA, Bos PK, Moelker A, Bierma-Zeinstra SMA, van der Heijden RA, Oei EHG. Genicular artery embolisation versus sham embolisation for symptomatic osteoarthritis of the knee: a randomised controlled trial. BMJ Open. 2024 Oct 1;14(10):e087047. doi: 10.1136/bmjopen-2024-087047.
PubMed 39353688Bagla S, Piechowiak R, Sajan A, Orlando J, Hartman T, Isaacson A. Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. J Vasc Interv Radiol. 2022 Jan;33(1):2-10.e2. doi: 10.1016/j.jvir.2021.09.019. Epub 2021 Oct 2.
PubMed 34610422Taslakian B, Miller LE, Mabud TS, Macaulay W, Samuels J, Attur M, Alaia EF, Kijowski R, Hickey R, Sista AK. Genicular artery embolization for treatment of knee osteoarthritis pain: Systematic review and meta-analysis. Osteoarthr Cartil Open. 2023 Feb 6;5(2):100342. doi: 10.1016/j.ocarto.2023.100342. eCollection 2023 Jun.
PubMed 36865988Ciaffi J, Papalexis N, Vanni E, Miceli M, Faldini C, Scotti L, Zambon A, Salvarani C, Caporali R, Facchini G, Ursini F. Minimally invasive interventional procedures for osteoarthritis and inflammatory arthritis: A systematic review and meta-analysis. Semin Arthritis Rheum. 2024 Oct;68:152525. doi: 10.1016/j.semarthrit.2024.152525. Epub 2024 Aug 5.
PubMed 39137511
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Discoveries in Vascular Embolization for New Treatments in Rheumatology: a Single-blind, Sham-controlled, Randomized Trial
- ClinicalTrials.gov ID
- NCT07873892
- Acronym / sponsor ID
- ADVENTURE / ADVENTURE
- Conditions
- Arthritis
- Keywords
- Embolization, Synovitis, Monoarthritis, Inflammatory arthritis, Refractory arthritis, Sham procedure, Interventional radiology, Gelatin microspheres
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- AUSL Bologna
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 14 Oct 2026 (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.
The goal of this clinical trial is to learn whether transarterial embolization (TAE) can relieve pain and improve well-being in adults with inflammatory arthritis that remains active in only one large joint (wrist, elbow, shoulder, ankle, knee or hip) despite anti-inflammatory drugs, joint injections and physiotherapy. The researchers expect that more people treated with TAE than with a sham (simulated) procedure will reach low pain and a good overall assessment of their health one month after the procedure.
The main questions it aims to answer are:
- Does TAE increase the proportion of participants who reach low pain and a good overall assessment of their health one month after the procedure, compared with a sham procedure?
- Is TAE safe, and does it improve quality of life and reduce the need for medication over three months?
TAE is a minimally invasive procedure. A thin catheter is guided through an artery in the groin or wrist to the small vessels that feed the inflamed lining of the joint, and tiny resorbable gelatin particles are injected to temporarily reduce the abnormal blood flow that sustains inflammation and pain. Researchers will compare TAE with a sham procedure to find out whether any benefit comes from the embolization itself rather than from the experience of undergoing a procedure.
Participants will:
- Be randomly assigned (like flipping a coin) to TAE or to the sham procedure. Neither the participants nor the doctor who evaluates them will know which procedure they received.
- Undergo the procedure in the angiography room with light sedation. The sham procedure takes place in the same room, with the same team, sedation and duration, but without any puncture of the artery, contrast medium or X-rays.
- Attend visits before the procedure and 1 week, 1 month and 3 months after it, answer questionnaires on pain and quality of life, and keep a diary of symptoms and medicines for 7 days after the procedure.
After 3 months, participants who received the sham procedure will be offered TAE.
Detailed description
Background and rationale
Inflammatory arthritis, including rheumatoid arthritis and the spondyloarthritides, may present with or persist as synovitis of a single joint, even in patients at target according to composite disease activity indices. Patients with monoarthritis have been excluded from registration trials of disease-modifying antirheumatic drugs, and when local treatments fail, escalation to systemic immunosuppression exposes them to class-wide risks (such as serious infections) for a benefit limited to one joint. Repeated intra-articular glucocorticoid injections carry cumulative local risks. Transarterial embolization (TAE) is a minimally invasive procedure that occludes the pathological neovessels of the inflamed synovium without systemic immunosuppression. Evidence on musculoskeletal embolization comes mainly from knee osteoarthritis, where sham-controlled trials have shown discordant results and a large response to the procedural context. In inflammatory arthritis, data are limited to case reports and small series. ADVENTURE is, to our knowledge, the first randomized sham-controlled trial of TAE in inflammatory arthritis.
Design
Single-centre, randomized, sham-controlled, parallel-group superiority trial conducted at IRCCS Istituto Ortopedico Rizzoli (IOR), Bologna, Italy. Potential participants are identified in the rheumatology clinics of IOR and of Azienda USL di Bologna, which refers eligible patients to IOR for consent and enrollment. Participants are randomized 1:1 to TAE or sham procedure using a computer-generated sequence stratified by joint site (upper limb: wrist, elbow, shoulder; lower limb: ankle, knee, hip). The procedure is performed within 4 weeks of randomization. Each participant is followed for 3 months, with visits at baseline, 1 week, 1 month and 3 months after the procedure.
Blinding
Participants and the rheumatologist who assesses outcomes are blinded to allocation for the entire 3-month follow-up. The allocation is communicated only to the interventional radiology team, which cannot be blinded, and procedural data are recorded on a separate case report form, stored separately from clinical data until the end of the trial. The protocol title describes the trial as single-blind; because the assessing rheumatologist is also blinded, masking is recorded here as Participant and Outcomes Assessor.
Interventions
Both procedures are performed in the same angiography suite, by the same team, with identical light sedation (midazolam 2 mg intravenously) and local anaesthesia, and last about 60 minutes. TAE is performed through ultrasound-guided femoral or radial arterial access: after superselective angiography of the arteries supplying the target joint, resorbable porcine gelatin microspheres (Nexsphere-F, 100-300 micrometres; CE-marked class III device) are injected until the pathological synovial blush disappears. Embolization is not performed if superselective angiography shows anatomical or vascular contraindications listed in the device instructions for use. In the sham procedure, a peripheral venous line is placed and a superficial subcutaneous puncture is made at the access site corresponding to the target joint, without arterial access; saline is infused and standardized angiographic sequences are displayed on the monitor. No contrast medium or ionizing radiation is administered in the sham arm. After either procedure, participants are observed for 4-5 hours and receive standardized instructions (compressive dressing for 3 days, local ice, paracetamol and, if needed, low-dose NSAIDs as rescue analgesia).
Open-label crossover
After the 3-month visit, participants allocated to sham are offered open-label TAE, with a follow-up visit 1 month after the procedure. These data are analysed separately and do not contribute to the randomized comparison.
Sample size and statistical analysis
Assuming a primary response rate of 60% with TAE and 10% with sham, a two-sided alpha of 0.05, 80% power and 10% loss to follow-up, 30 participants (15 per group) will be enrolled. The primary analysis follows the intention-to-treat principle, with missing data handled by multiple imputation by chained equations; the primary outcome is compared between groups with Fisher's exact test and the difference in proportions is reported with its 95% confidence interval. A per-protocol analysis is performed as sensitivity analysis. Secondary outcomes are analysed with non-parametric or parametric tests as appropriate and with linear mixed models for repeated measures; they are considered exploratory.
Safety monitoring
An independent Data Safety Monitoring Board (a biostatistician, an interventional radiologist and an orthopaedic surgeon) reviews recruitment, data quality, protocol adherence and adverse events before recruitment begins, after the first 10 participants, annually and whenever a relevant serious adverse event occurs. Data are collected in REDCap with automated range and consistency checks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel arms randomized 1:1 (TAE vs sham procedure), stratified by joint site (upper vs lower limb). After the 3-month randomized phase, participants in the sham arm are offered open-label TAE; these data are analysed separately and do not contribute to the randomized comparison.
| Arm | Type | Receives |
|---|---|---|
| Transarterial embolization | Experimental | Device: Transarterial embolization with resorbable gelatin microspheresParticipants undergo transarterial embolization of the target joint in the angiography suite under light sedation (midazolam 2 mg intravenously) and local anaesthesia. Through ultrasound-guided femoral or radial arterial access, a microcatheter is advanced into the arteries supplying the inflamed synovium and resorbable gelatin microspheres (100-300 micrometres) are injected until the pathological blush disappears. The procedure lasts about 60 minutes and is performed within 4 weeks of randomization. |
| Sham procedure | Sham comparator | Device: Sham embolization procedureParticipants undergo a simulated procedure in the same angiography suite, with the same team, identical light sedation (midazolam 2 mg intravenously) and local anaesthesia, and similar duration (about 60 minutes). A superficial subcutaneous puncture is made at the access site corresponding to the target joint, without arterial access; saline is infused and standardized angiographic sequences are displayed on the monitor. No contrast medium, embolic agent or ionizing radiation is administered. After the 3-month visit, participants are offered open-label transarterial embolization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Inflammatory monoarthritis of a large joint (wrist, elbow, shoulder, ankle, knee or hip), fulfilling the ASAS classification criteria for peripheral spondyloarthritis, or diagnosed clinically and on imaging by a rheumatologist when of other aetiology.
- Refractoriness to local and pharmacological treatment, defined as failure of both: (a) at least two different non-steroidal anti-inflammatory drugs (NSAIDs) at full dose and for an adequate duration; and (b) at least one intra-articular glucocorticoid injection into the target joint. Patients who have also failed one or more conventional synthetic DMARDs (methotrexate, leflunomide or sulfasalazine) at adequate doses for at least 3 months, and patients with a documented contraindication to starting or continuing systemic immunosuppressive therapy, are also eligible.
- Failure of structured physiotherapy.
- Pain visual analogue scale (VAS) score of 40 mm or more (0-100 mm scale) at baseline.
Key exclusion criteria (8 listed)
- Active inflammatory involvement of more than one joint.
- Contraindications to angiography: allergy to iodinated contrast medium, severe renal impairment (estimated glomerular filtration rate <30 mL/min) or uncorrectable coagulopathy.
- Intra-articular injection into the target joint within the previous 3 months.
- Change in disease-modifying antirheumatic drug (DMARD) therapy within the month before enrollment.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Transarterial embolization with resorbable gelatin microspheresSuperselective transarterial embolization of the arteries supplying the inflamed synovium of the target joint, using resorbable porcine gelatin microspheres (100-300 micrometres; CE-marked class III device) injected through a coaxial microcatheter until the pathological blush disappears. Ultrasound-guided femoral or radial access, light sedation with midazolam 2 mg IV and local anaesthesia. Single procedure. | Device | Transarterial embolization |
| Sham embolization procedureSimulated embolization procedure in the angiography suite with identical sedation (midazolam 2 mg IV), local anaesthesia and duration as the active procedure. Superficial subcutaneous puncture at the access site without arterial access, saline infusion and display of standardized angiographic sequences. No contrast medium, embolic agent or ionizing radiation. Single procedure. | Device | Sham procedure |
Primary outcome
Proportion of participants with pain VAS ≤15 mm and Patient Global Assessment ≤20 mm.
Time frame: 1 month after the procedure.
The proportion of participants achieving both a pain visual analogue scale (VAS) score <15 mm, referred to the target joint, and a Patient Global Assessment (PGA) of health status <20 mm, both measured on a 0-100 mm scale (higher scores indicate worse status). Thresholds are derived from the pain and patient global components of the minimal disease activity criteria for psoriatic arthritis. The proportion is compared between the transarterial embolization and sham arms by intention to treat.
7 secondary outcomes
Change in pain VAS from baseline.
Time frame: Baseline, 1 week and 3 months after the procedure.
Change in Patient Global Assessment from baseline.
Time frame: Baseline, 1 week and 3 months after the procedure.
Health-related quality of life measured with the EQ-5D
Time frame: Baseline, 1 week, 1 month and 3 months after the procedure.
Health-related quality of life measured with the SF-36.
Time frame: Baseline, 1 week, 1 month and 3 months after the procedure.
Change in medication use.
Time frame: From baseline to 3 months after the procedure.
Incidence of adverse events.
Time frame: From the procedure to 3 months after the procedure.
Patient satisfaction and willingness to repeat the procedure.
Time frame: 1 month and 3 months after the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Background: PubMed 41307394Ursini F, Ciaffi J, Peta G, Faldini C, Facchini G. Transarterial Embolization for Refractory Ankle Synovitis in an Adult Patient With a History of Juvenile Idiopathic Arthritis. ACR Open Rheumatol. 2025 Dec;7(12):e70141. doi: 10.1002/acr2.70141.
- Background: PubMed 37051829Landers S, Hely R, Hely A, Harrison B, Page RS, Maister N, Gwini SM, Gill SD. Genicular artery embolization for early-stage knee osteoarthritis: results from a triple-blind single-centre randomized controlled trial. Bone Jt Open. 2023 Mar 10;4(3):158-167. doi: 10.1302/2633-1462.43.BJO-2022-0161.R2.
- Background: PubMed 39353688van Zadelhoff TA, Bos PK, Moelker A, Bierma-Zeinstra SMA, van der Heijden RA, Oei EHG. Genicular artery embolisation versus sham embolisation for symptomatic osteoarthritis of the knee: a randomised controlled trial. BMJ Open. 2024 Oct 1;14(10):e087047. doi: 10.1136/bmjopen-2024-087047.
- Background: PubMed 34610422Bagla S, Piechowiak R, Sajan A, Orlando J, Hartman T, Isaacson A. Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. J Vasc Interv Radiol. 2022 Jan;33(1):2-10.e2. doi: 10.1016/j.jvir.2021.09.019. Epub 2021 Oct 2.
- Background: PubMed 36865988Taslakian B, Miller LE, Mabud TS, Macaulay W, Samuels J, Attur M, Alaia EF, Kijowski R, Hickey R, Sista AK. Genicular artery embolization for treatment of knee osteoarthritis pain: Systematic review and meta-analysis. Osteoarthr Cartil Open. 2023 Feb 6;5(2):100342. doi: 10.1016/j.ocarto.2023.100342. eCollection 2023 Jun.
- Background: PubMed 39137511Ciaffi J, Papalexis N, Vanni E, Miceli M, Faldini C, Scotti L, Zambon A, Salvarani C, Caporali R, Facchini G, Ursini F. Minimally invasive interventional procedures for osteoarthritis and inflammatory arthritis: A systematic review and meta-analysis. Semin Arthritis Rheum. 2024 Oct;68:152525. doi: 10.1016/j.semarthrit.2024.152525. Epub 2024 Aug 5.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The informed consent approved by the ethics committee restricts access to participant data to the sponsor, the investigators, the ethics committee and regulatory authorities, and provides for dissemination of results in aggregate form only. Aggregate results will be published in peer-reviewed journals.
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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.
Jacopo Ciaffi, MD, PhD principal investigator
IRCCS Istituto Ortopedico Rizzoli, Bologna
Questions about this trial
What is this clinical trial studying?
A study testing Transarterial embolization with resorbable gelatin microspheres in people with Arthritis, run by Istituto Ortopedico Rizzoli.
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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacopo Ciaffi, MD, PhD (+39 051 644 5505, jacopo.ciaffi@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with pain VAS ≤15 mm and Patient Global Assessment ≤20 mm. (time frame: 1 month after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07873892, which also lists 6 linked publications.
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 14 Oct 2026.