EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications (EASYX-1)

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).

Study Overview

• Status: Completed
• Conditions: Bleeding; Angiomyolipoma; Portal Vein Thrombosis; Varicocele; Endoleak
• Intervention / Treatment: Device: Easyx

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75908
      • AP-HP - Hôpital Européen Georges-Pompidou Paris, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient presenting with indication of varicocele, type II endoleaks, portal vein, AML or active embolization with a liquid agent
• Aged ≥ 18 years
• Affiliated to a French health insurance system

Exclusion Criteria:

• Hypersensitivity to Polyvinyl Alcohol (PVA) Polymer
• Hypersensitivity to DMSO solvent
• Patient unable or unwilling to provide a written informed consent
• Patient participating in another interventional study
• Pregnant or breastfeeding woman
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety:Total number of per-procedure Serious Adverse Events (SAE) for the safety	Expected and unexpected per-procedure (SAE) related to the EASYX™ use (imputability "certain" or "probable")	one day
Efficacy for type 2 endoleaks embolization	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).	6 months
Efficacy for portal vein embolization	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	Before ablation
Efficacy for varicocele embolization	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.	1 month
Efficacy for angiomyolipoma embolization	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	3 month
Efficacy for active bleeding embolization	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	Through embolization completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAE	Total number of SAE	up to 6 months
AE	Total number of AE	up to 6 months
untargeted embolization	Total number of untargeted embolization	during procedure
unanticipated ischemia of the target organ	Total number of unanticipated ischemia of the target organ	up to 6 months
orchi-epididymitis	Total number of secondary post-embolization orchi-epididymitis (varicocele embolization)	up to 6 months
neural route lesion	Total number of neural root lesion (type II endoleaks)	up to 6 months
aneurysm rupture	Total number of aneurysm rupture (type II endoleaks)	up to 6 months
tumor rupture	Total number of tumor rupture (angiomyolipoma)	up to 6 months
Survival	Survival rates	6 months
Pain	Use of Visual Analog Scale (VAS) to evaluate the pain at device injection (between 0: no pain to 10: intolerable pain)	up to 6 months
Pain improvement	Use of Visual Analog Scale (VAS) to evaluate the painful varicocele (between 0: no pain to 10: intolerable pain)	up to 6 months
unanticipated use of another liquid agent	Total number of unanticipated use of another liquid agent for embolization	during procedure
technical success	Total number of procedures with immediate technical success	end of the procedure
Easyx volume	Mean volume of EASYX™ used during the index procedure	during procedure
Occlusion	Mean degree of occlusion of the target vessel(s)	during procedure
Re-intervention	Total number of re-intervention for study procedure	up to 6 months
Interventional Radiologist (IR) satisfaction	Immediate technical satisfaction questionnaire (as perceived by the Interventional Radiologist)	end of the procedure
Clinical efficacy	Total number of embolization clinical efficacy	up to 6 months
Other liquid embolics	Total number of procedures with a need to complete with another liquid embolic to achieve optimal result	end of the procedure
Quality of life	Patient's quality of life (EQ-5D)	up to 6 months
Imaging	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	6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Antia Therapeutics AG
• Investigators: Principal Investigator: Marc SAPOVAL, MD, PhD, AP-HP - Hôpital Europeen 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 record dates

Study Major Dates

• Study Start (Actual): March 30, 2018
• Primary Completion (Actual): March 11, 2020
• Study Completion (Actual): March 11, 2020

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: liquid embolics
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Postoperative Complications; Hemorrhage; Embolism and Thrombosis; Perivascular Epithelioid Cell Neoplasms; Aneurysm; Neoplasms, Adipose Tissue; Postoperative Hemorrhage; Thrombosis; Varicocele; Endoleak; Angiomyolipoma
• Other Study ID Numbers: K170403J; 2017-A02370-53 (Other Identifier: EUDRACT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No