EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications
Study Details
Study Description
Brief Summary
The EASYX™ Liquid Embolic is a new injectable, precipitating polymeric agent for the obliteration of vascular spaces through direct puncture or catheter access performed under X-ray guidance. The embolic liquid is an iodinized Polyvinyl Alcohol (PVA) Polymer ether. Iodine groups are covalently grafted to the PVA polymer backbone, whereby a stable nondegradable polymer with the desired features is created. The resulting polymer is dissolved in Dimethyl Sulfoxide (DMSO). EASYX™ is CE-marked since December 2016 and has been used in humans a few time for type II endoleaks, portal vein and varicocele (<10 cases at the date of submission). The purpose of this study is to evaluate the safety and efficacy of EASYX™ embolization liquid for the percutaneous treatment of vascular lesions, i.e. embolization of varicocele, type II endoleaks, portal vein before surgery, active peripheral bleeding or angiomyolipoma (AML).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Embolization with Easyx Patients requiring embolization of varicocele, portal vein before ablation, type 2 endoleak, angiomyolipoma or active bleeding will be treated with the liquid embolic agent Easyx during index procedure. |
Device: Easyx
Embolization will be done with Easyx liquid agent.
|
Outcome Measures
Primary Outcome Measures
- Safety:Total number of per-procedure Serious Adverse Events (SAE) for the safety [one day]
Expected and unexpected per-procedure (SAE) related to the EASYX™ use (imputability "certain" or "probable")
- Efficacy for type 2 endoleaks embolization [6 months]
Percentage of clinical success. The clinical success of type II endoleaks embolization is defined as the stability or reduction of aneurysm's both anterioposterior and transverse diameters assessed on CT-scan at 6 months compared to baseline (4mm threshold).
- Efficacy for portal vein embolization [Before ablation]
Percentage of clinical success before ablation for portal vein embolization. The clinical success of portal vein embolization is defined as the growth ≥15 % of the remnant liver assessed on presurgical CT-scan compared to baseline
- Efficacy for varicocele embolization [1 month]
Percentage of clinical success for varicocele embolization The clinical success of varicocele embolization is defined as the absence of reflux on ultrasound Doppler at one month follow-up.
- Efficacy for angiomyolipoma embolization [3 month]
Percentage of clinical success for angiomyolipoma embolization. The clinical success of angiomyolipoma embolization is defined as the reduction >10% of at least one diameter on MRI or CT-scan at 3 months follow-up compared to baseline
- Efficacy for active bleeding embolization [Through embolization completion]
Percentage of clinical success for active bleeding embolization The clinical success of active bleeding embolization is defined as the complete occlusion of the target vessel assessed by angiography during the index procedure
Secondary Outcome Measures
- SAE [up to 6 months]
Total number of SAE
- AE [up to 6 months]
Total number of AE
- untargeted embolization [during procedure]
Total number of untargeted embolization
- unanticipated ischemia of the target organ [up to 6 months]
Total number of unanticipated ischemia of the target organ
- orchi-epididymitis [up to 6 months]
Total number of secondary post-embolization orchi-epididymitis (varicocele embolization)
- neural route lesion [up to 6 months]
Total number of neural root lesion (type II endoleaks)
- aneurysm rupture [up to 6 months]
Total number of aneurysm rupture (type II endoleaks)
- tumor rupture [up to 6 months]
Total number of tumor rupture (angiomyolipoma)
- Survival [6 months]
Survival rates
- Pain [up to 6 months]
Use of Visual Analog Scale (VAS) to evaluate the pain at device injection (between 0: no pain to 10: intolerable pain)
- Pain improvement [up to 6 months]
Use of Visual Analog Scale (VAS) to evaluate the painful varicocele (between 0: no pain to 10: intolerable pain)
- unanticipated use of another liquid agent [during procedure]
Total number of unanticipated use of another liquid agent for embolization
- technical success [end of the procedure]
Total number of procedures with immediate technical success
- Easyx volume [during procedure]
Mean volume of EASYX™ used during the index procedure
- Occlusion [during procedure]
Mean degree of occlusion of the target vessel(s)
- Re-intervention [up to 6 months]
Total number of re-intervention for study procedure
- Interventional Radiologist (IR) satisfaction [end of the procedure]
Immediate technical satisfaction questionnaire (as perceived by the Interventional Radiologist)
- Clinical efficacy [up to 6 months]
Total number of embolization clinical efficacy
- Other liquid embolics [end of the procedure]
Total number of procedures with a need to complete with another liquid embolic to achieve optimal result
- Quality of life [up to 6 months]
Patient's quality of life (EQ-5D)
- Imaging [6 months]
Technical success at follow-up assessed on CT-scan for type II endoleaks defined as the ability for the physician to give a diagnosis (absence or minor artifacts) on imaging
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient presenting with indication of varicocele, type II endoleaks, portal vein, AML or active embolization with a liquid agent
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Aged ≥ 18 years
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Affiliated to a French health insurance system
Exclusion Criteria:
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Hypersensitivity to Polyvinyl Alcohol (PVA) Polymer
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Hypersensitivity to DMSO solvent
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Patient unable or unwilling to provide a written informed consent
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Patient participating in another interventional study
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Pregnant or breastfeeding woman
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Prisoners
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AP-HP - Hopital Europeen Georges-Pompidou Paris, France | Paris | Ile-de-France | France | 75908 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
- Antia Therapeutics AG
Investigators
- Principal Investigator: Marc SAPOVAL, MD, PhD, AP-HP - Hôpital Européen Georges Pompidou
- Principal Investigator: Romaric LOFFROY, MD, PhD, CHU de Dijon - Hôpital François Mitterand
- Principal Investigator: Vincent VIDAL, MD, PhD, AP-HM - La Timone
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K170403J
- 2017-A02370-53