Aneurysm, Hemorrhage, Hypervascular Tumor, Pathological Organ, Portal Vein Embolization, Pseudoaneurysm, Type II Endoleak, Varicose Veins, Vascular Anomalies
Conditions
Keywords
liquid embolic agent, peripheral vascular embolization, embolization, endovascular therapy, interventional radiology
Brief summary
A prospective, single-arm, multicenter, open-label, First-in-Human & Pivotal Study to assess the safety and efficacy of amber SEL-P in 70 patients requiring peripheral embolization: vascular anomalies, hemorrhages, aneurysms, and pseudoaneurysms, varicose veins, portal vein, hypervascular tumors, type -II endoleaks, and pathological organs. The study will be divided into two consecutive stages. Stage I will be dedicated to testing the device's safety, followed immediately by stage II, aimed to test the device's efficacy. The overall study sample will be used to assess the device safety and efficacy in all the enrolled participants.
Interventions
DEVICEamber SEL-P Peripheral Liquid Embolic System
Transcatheter arterial or venous embolization with the liquid embolic agent amber SEL-P embolization across seven different indications for peripheral embolization.
Sponsors
LVD Biotech S.L
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 94 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥ 18 and \< 95 years presenting with one of the following indications: * Varicose vein embolization: * Pelvic congestion syndrome (uterine venous engorgement, and/or moderate or severe engorgement of the ovarian plexus, and/or filling of the veins across the midline or filling of vulvar or thigh varicosities, and/or reflux throughout the entire course of the ovarian vein. * Varicocele (symptomatic varicocele, and/or infertility or subfertility). * Varicose veins in patients with portal hypertension undergoing Transjugular Intrahepatic Portosystemic Shunt (TIPS) that require embolization. * Type II endoleak: Persistent type II endoleak and/or an associated sac expansion \> 5 mm after 6 months or 10 mm after 12 months. * Insufficient liver remnant requiring portal vein embolization (PVE) before liver resection: Predicted insufficient liver remnant after surgery (≤20% in a normal liver, ≤30% in liver with intermediate disease without cirrhosis, and ≤40% in liver with cirrhosis) * Active arterial hemorrhage and/or pseudoaneurysm: Uncontrolled massive hemorrhage caused by tumor, trauma or arteriovenous shunt formation (congenital or acquired), and/or up to 3 bleeding sites in the same organ or anatomic region * Pathologic organ (i.e. non-functioning transplanted kidney, preoperative hip replacement, hypersplenism conditioning low platelet count; excluding brain) * Hypervascular tumors * Vascular anomalies
Exclusion criteria
* Patients with known hypersensitivity or allergy to amber-20, dimethylsulfoxide (DMSO) solvent, or contrast agent * Previously failed embolization procedure, except for those treated with coils * Patient in whom according to the investigator criteria a complete vascular occlusion would not be feasible in a single procedure * Any condition that exposes the patient to a high risk for complications according to the investigator's criteria (e.g., but not limited to, non-correctable coagulopathy, uncontrolled sepsis, underlying life-threatening condition, etc.) * Patients participating in another interventional study that has not completed it primary endpoint assessment. * Pregnant or breastfeeding women. * Patients unable or unwilling to provide a written informed consent. * Recurrent varicose vein embolization * Type II endoleak: with high flow or reflux that cannot be prevented using coils or balloon microcatheter, and high risk of medullar ischemic damage * Active arterial bleeding and/or pseudo aneurysm with: severe hemodynamical instability (e.g., but not limited to, sustained hypotension \[mean arterial pressure \< 60 mmHg\], tachycardia \>120 beats/minute, requirement of high doses of vasopressors, etc.) at the moment of the procedure, and/or hb \< 8 g/dL before the procedure, and/or retroperitoneal hemorrhages or hemoptysis, identification of spinal or medullar vessels. * Central nervous system and central circulatory system vascular anomalies. * Iodine contrast allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peri-procedure serious adverse events related to amber SEL-P (Stage I) | Up to 24 hours after embolization procedure | Rate of peri-procedure serious adverse events related to amber SEL-P (device-related but not related to the procedure) at 24 hours, adjudicated by an independent clinical events committee. |
| Rate of complete vascular occlusion (Stage II) | Embolization procedure day | Rate of complete vascular occlusion as defined by angiography at the end of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of any peri-procedure adverse events related to amber SEL-P (Stage I) | Up to 24 hours after embolization procedure | Rate of any peri-procedure adverse events related to amber SEL-P (device-related but not related to the procedure) at 24 hours, adjudicated by an independent clinical events committee. |
| Rate of complete vascular occlusion according clinical indication (Stage II) | Embolization procedure day | Rate of complete vascular occlusion as defined by angiography at the end of the procedure according to clinical indication. * Vascular anomalies (excluding the central nervous system and central circulatory system). * Hemorrhages, aneurysms, and pseudoaneurysms. * Varicose veins (including hemorrhoids, varicocele, and pelvic congestion syndrome). * Portal embolization. * Hypervascular tumors. * Type II endoleaks. * Pathological organs (renal grafts, hypersplenism). |
| Rate of peri-procedure serious adverse events related to amber SEL-P (Stage II) | Up to 24 hours after embolization procedure | Rate of peri-procedure serious adverse events related to amber SEL-P (device-related but not related to the procedure) at 24 hours, adjudicated by an independent clinical events committee. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Any Adverse Events (Stage I and Stage II) | up to 6 moonths | otal number of any adverse events |
| Survival rate (Stage I and Stage II) | up to 6 moonths | Survival rate |
| Visual Analog Scale (VAS) injection (Stage I and Stage II) | Embolization procedure day | Visual Analog Scale (VAS) to evaluate the pain at device injection (between 0: no pain to 10: intolerable pain) |
| Visual Analog Scale (VAS) varicose vein (Stage I and Stage II) | up to 6 moonths | Visual Analog Scale (VAS) to evaluate pain improvement in patients with painful varicose vein embolization |
| Unanticipated uses of another liquid agent (Stage I and Stage II) | Embolization procedure day | Total number of unanticipated uses of another liquid agent for embolization |
| Peri-procedure serious adverse event (Stage I and Stage II) | Up to 24 hours after embolization procedure | Rate of peri-procedure serious adverse events related to amber SEL-P (device-related but not related to the procedure) at 24 hours, adjudicated by an independent clinical events committee. |
| Vials per patient of amber SEL-P (Stage I and Stage II) | Embolization procedure day | Mean vials per patient of amber SEL-P used during the index procedure |
| Degree of occlusion (Stage I and Stage II) | Embolization procedure day | Mean degree of occlusion of the target vessel(s). |
| Re-interventions (Stage I and Stage II) | up to 6 moonths | Total number of re-interventions for the study procedure. |
| Clinical success | up to 6 moonths, depending on indication | oVaricose vein embolization: absence of reflux on ultrasound Doppler at 1M FU, reduction in macroscopic varicose veins and or improvement of pain at least 2 points measured by means of visual analogue scale (VAS). oType II endoleaks: stability or reduction of the aneurysm's anteroposterior and transverse maximal diameters on a computed tomography (CT) scan at 6 months compared with baseline (4-mm growth threshold). oPVE: growth of the future liver remnant (FLR) by \>15% assessed on a presurgical CT scan compared with baseline. oHemorrhage, aneurysm, pseudoaneurysm, pathologic organ: complete occlusion of the target vessel as assessed by angiography during the index procedure. o Hypervascular tumor and vascular anomalies : Correct devascularization of the treated lesion (intentionally complete or incomplete defined at the end of the procedure). |
| EQ-5D (Stage I and Stage II) | up to 6 moonths | Baseline and follow-up patient's quality of life EQ-5D (unabbreviated: EuroQol 5-dimensions ). Health state index scores generally range from 0 (dead) to 1 (perfect health), with higher scores indicating higher health utility. |
| Volume of amber SEL-P (Stage I and Stage II) | Embolization procedure day | Mean volume of amber SEL-P used during the index procedure |
| Technical success (Stage I and Stage II) | Embolization procedure day | Rate of complete vascular occlusion as defined by angiography at the end of the procedure |
| Peri-procedure adverse events (Stage I and Stage II) | Up to 24 hours after embolization procedure | ate of any peri-procedure adverse events related to amber SEL-P (device-related but not related to the procedure) at 24 hours, adjudicated by an independent clinical events committee. |
| Technical success per indication (Stage I and Stage II) | Embolization procedure day | Rate of complete vascular occlusion as defined by angiography at the end of the procedure according to clinical indication |
| Any Serious Adverse Events (Stage I and Stage II) | up to 6 moonths | Total number of any serious adverse events |
Countries
Spain
Outcome results
None listed