Clinical trial NCT06456125: Safety and Efficacy Of Amber Peripheral Liquid Embolic System
Official title: Safety and Efficacy Of Amber Peripheral Liquid Embolic System: a First-in-HumAn & PivotaL Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vascular Anomalies
Hemorrhage
Aneurysm
Pseudoaneurysm
Varicose Veins
Portal Vein Embolization
Hypervascular Tumor
Type II Endoleak
Pathological Organ
Keywords: liquid embolic agent
peripheral vascular embolization
embolization
endovascular therapy
interventional radiology
Lead sponsor: LVD Biotech S.L
Sponsor class: INDUSTRY
First posted: 2024-06-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 94
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Peri-procedure serious adverse events related to amber SEL-P (Stage I)
timeFrame: Up to 24 hours after embolization procedure
measure: Rate of complete vascular occlusion (Stage II)
timeFrame: Embolization procedure day
Secondary outcomes:
measure: Rate of any peri-procedure adverse events related to amber SEL-P (Stage I)
timeFrame: Up to 24 hours after embolization procedure
measure: Rate of complete vascular occlusion according clinical indication (Stage II)
timeFrame: Embolization procedure day
measure: Rate of peri-procedure serious adverse events related to amber SEL-P (Stage II)
timeFrame: Up to 24 hours after embolization procedure
Other outcomes:
measure: Peri-procedure serious adverse event (Stage I and Stage II)
timeFrame: Up to 24 hours after embolization procedure
measure: Technical success (Stage I and Stage II)
timeFrame: Embolization procedure day
measure: Peri-procedure adverse events (Stage I and Stage II)
timeFrame: Up to 24 hours after embolization procedure
measure: Technical success per indication (Stage I and Stage II)
timeFrame: Embolization procedure day
measure: Any Serious Adverse Events (Stage I and Stage II)
timeFrame: up to 6 moonths
measure: Any Adverse Events (Stage I and Stage II)
timeFrame: up to 6 moonths
measure: Survival rate (Stage I and Stage II)
timeFrame: up to 6 moonths
measure: Visual Analog Scale (VAS) injection (Stage I and Stage II)
timeFrame: Embolization procedure day
measure: Visual Analog Scale (VAS) varicose vein (Stage I and Stage II)
timeFrame: up to 6 moonths
measure: Unanticipated uses of another liquid agent (Stage I and Stage II)
timeFrame: Embolization procedure day
measure: Volume of amber SEL-P (Stage I and Stage II)
timeFrame: Embolization procedure day
measure: Vials per patient of amber SEL-P (Stage I and Stage II)
timeFrame: Embolization procedure day
measure: Degree of occlusion (Stage I and Stage II)
timeFrame: Embolization procedure day
measure: Re-interventions (Stage I and Stage II)
timeFrame: up to 6 moonths
measure: Clinical success
timeFrame: up to 6 moonths, depending on indication
measure: EQ-5D (Stage I and Stage II)
timeFrame: up to 6 moonths
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario Y Politécnico La Fe
Study officials:
affiliation: Hospital Universitario La Fe
name: Fernando Gómez
role: PRINCIPAL_INVESTIGATOR
References: