Safety and Efficacy Of Amber Peripheral Liquid Embolic System

NCT06456125 | Active Not Recruiting

• 1 other identifier: amber SEL-P-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Peri-procedure serious adverse events related to amber SEL-P (Stage I)

  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.

  Up to 24 hours after embolization procedure

• Rate of complete vascular occlusion (Stage II)

  Rate of complete vascular occlusion as defined by angiography at the end of the procedure.

  Embolization procedure day

Secondary Outcomes (3)

• Rate of any peri-procedure adverse events related to amber SEL-P (Stage I)

  Up to 24 hours after embolization procedure

• Rate of complete vascular occlusion according clinical indication (Stage II)

  Embolization procedure day

• Rate of peri-procedure serious adverse events related to amber SEL-P (Stage II)

  Up to 24 hours after embolization procedure

Other Outcomes (16)

• Peri-procedure serious adverse event (Stage I and Stage II)

  Up to 24 hours after embolization procedure

• Technical success (Stage I and Stage II)

  Embolization procedure day

• Peri-procedure adverse events (Stage I and Stage II)

  Up to 24 hours after embolization procedure

Study Arms (1)

amber SEL-P Treatment

EXPERIMENTAL

Patients requiring peripheral embolization: vascular anomalies, hemorrhages, aneurysms, and pseudoaneurysms, varicose veins (including varicocele and pelvic congestion syndrome), portal vein, hypervascular tumors, type -II endoleaks, and pathological organs.

Device: amber SEL-P Peripheral Liquid Embolic System

Interventions

amber SEL-P Peripheral Liquid Embolic System DEVICE

Transcatheter arterial or venous embolization with the liquid embolic agent amber SEL-P embolization across seven different indications for peripheral embolization.

amber SEL-P Treatment

Eligibility Criteria

• Age: 18 Years - 94 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LVD Biotech S.L: lead

Study Sites (1)

Hospital Universitario Y Politécnico La Fe

Valencia, Spain

Location

MeSH Terms

Conditions

Vascular Malformations; Hemorrhage; Aneurysm; Aneurysm, False; Varicose Veins

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Fernando Gómez

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 13, 2024
• Study Start: June 12, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)