Splenic Artery Embolization for Splenic Injuries

(ELSA-2 Trial)

Recruiting at 4 trial locations

Overseen By Evan Hudson, BS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Andrew J. Gunn

Disqualifiers: Immunocompromised, Pregnant, Breast-feeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Immediate procedure

250 Participants Needed

Trial Summary

What is the purpose of this trial?

Our aim is to conduct a multi-center, Bayesian, randomized clinical trial to evaluate the primary technical success of coils and vascular plugs for proximal splenic artery embolization in the setting of high-grade splenic trauma. The investigator has previously demonstrated the feasibility of such a study in a single center pilot trial.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Splenic Artery Embolization for Splenic Injuries?

Research shows that using vascular plugs in splenic artery embolization can reduce the time needed for the procedure compared to using coils, which may lead to less radiation exposure for patients. This suggests that vascular plugs might be a more efficient option for treating splenic injuries. ^{1 2 3 4 5}

Is splenic artery embolization using vascular plugs or coils safe for humans?

Research shows that splenic artery embolization using vascular plugs or coils is generally safe for treating splenic injuries in humans, with studies comparing these devices focusing on technical outcomes and radiation exposure rather than safety concerns. ^{2 3 4 5 6}

How does the treatment of splenic artery embolization using vascular embolic coils or plugs differ from other treatments for splenic injuries?

Splenic artery embolization using vascular embolic coils or plugs is unique because it allows for precise placement in the artery, which can be crucial for effective treatment. Vascular plugs, in particular, are associated with reduced fluoroscopy times (the time spent using X-ray guidance) compared to coils, potentially making the procedure quicker and more efficient. ^{1 2 4 7 8}

Eligibility Criteria

This trial is for individuals over 15 years old who have a high-grade splenic injury from trauma, as seen on a CT scan. They must be candidates for non-surgical treatment and weigh more than 50kg. People can't join if they have severe blood clotting issues, are pregnant or breastfeeding, don't speak English, are prisoners, immunocompromised, or unable to consent.

Inclusion Criteria

My spleen injury is being treated without surgery, as decided by my doctors.

I have a severe spleen injury shown on a CT scan.

I am 15 years old or older.

Exclusion Criteria

Non-English speakers

Breast-feeding

I weigh 50kg or less.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo splenic artery embolization using either vascular embolic coils or plugs

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

1 visit (in-person)

Long-term Follow-up

Participants are monitored for long-term outcomes and technical success

3 years

Treatment Details

Interventions

• Vascular Embolic Coils or Plugs

Trial Overview The study tests how well two different devices—vascular embolic coils and plugs—work in blocking the splenic artery to control bleeding after serious spleen injuries. Patients will be randomly assigned one of these methods in multiple hospitals.

Participant Groups

Group I: Active Comparator: Splenic artery embolization with vascular embolic coils Active Control 1 Intervention

Device: Splenic artery embolization with vascular embolic coils

Group II: Active Comparator: Splenic artery embolization with vascular embolic plugs Active Control 1 Intervention

Active Comparator: Splenic artery embolization with vascular embolic plugs

Vascular Embolic Coils or Plugs is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Vascular Embolic Coils or Plugs for:

• High-grade splenic trauma
• Splenic artery aneurysms
• Gastroesophageal varices

Approved in United States as Vascular Embolic Coils or Plugs for:

• High-grade splenic trauma
• Splenic artery aneurysms
• Portal hypertension

Approved in Canada as Vascular Embolic Coils or Plugs for:

• High-grade splenic trauma
• Splenic artery aneurysms
• Gastroesophageal varices

Who Is Running the Clinical Trial?

Andrew J. Gunn

Lead Sponsor

Trials

1

Recruited

250+

Penumbra Inc.

Industry Sponsor

Trials

38

Recruited

10,800+

Findings from Research

The study successfully enrolled 46 out of 50 eligible patients (92%) in a randomized controlled trial comparing endovascular coils (EC) and vascular plugs (VP) for treating high-grade splenic trauma, indicating that such trials are feasible.

Both EC and VP demonstrated excellent splenic salvage rates of 98%, with primary technical success rates suggesting a higher likelihood of success for EC compared to VP, while complications were low for both methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of endovascular coils and vascular plugs for proximal splenic artery embolization in high-grade splenic trauma. Gunn, AJ., Raborn, JR., Griffin, R., et al.[2021]

In a study of 26 patients with traumatic splenic injuries, both vascular plugs and endovascular coils were effective for proximal splenic artery embolization, achieving a 100% splenic salvage rate with no major complications.

Using vascular plugs resulted in significantly lower fluoroscopy times (14.5 minutes) compared to endovascular coils (34.0 minutes), suggesting a more efficient procedure without compromising safety or efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular plugs are associated with reduced fluoroscopy times compared to endovascular coils in proximal splenic artery embolization in trauma. Glenn, AM., Huang, J., Gunn, AJ., et al.[2022]

The Amplatzer Vascular Plug (AVP) demonstrated precise deployment and resistance to migration in proximal splenic artery embolization (SAE), with successful use in 18 out of 18 cases, compared to 31.8% migration in coil procedures.

AVP procedures resulted in a significantly lower radiation dose (842 mGy) compared to coils (1,309 mGy), making it a safer option in terms of radiation exposure, although the need for additional embolic material may limit its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of the Amplatzer Vascular Plug in splenic artery embolization: a comparison study with conventional coil technique. Zhu, X., Tam, MD., Pierce, G., et al.[2011]

In a study involving 14 patients, the Amplatzer vascular plug (AVP) was successfully used for precise proximal splenic artery embolization, demonstrating effective placement and occlusion without complications.

The procedure achieved occlusion in an average of 10 minutes, and follow-up CT scans confirmed no device migration or recanalization, indicating the safety and efficacy of the AVP for splenic salvage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Amplatzer vascular plug for proximal splenic artery embolization. Widlus, DM., Moeslein, FM., Richard, HM.[2019]

In a meta-analysis of eight studies involving 133 patients, vascular plugs were found to achieve faster vessel occlusion times (7.11 minutes quicker) and required fewer devices compared to coil embolization for splenic artery procedures.

Patients treated with vascular plugs experienced significantly less radiation exposure (439 mGy less) and shorter fluoroscopy times (13.82 minutes shorter), indicating a safer profile for this method compared to coils.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of Intraprocedural Comparative Effectiveness of Vascular Plugs Vs Coils in Proximal Splenic Artery Embolization and Associated Patient Radiation Exposure. Johnson, P., Wong, K., Chen, Z., et al.[2022]

The Cera vascular plug, delivered through the innovative FuStar steerable introducer sheath, demonstrated improved safety and efficacy in a pig model, resulting in shorter fluoroscopy times and reduced contrast medium usage compared to a control introducer.

At a 2-month follow-up, the Cera plug showed persistent occlusion in 18 out of 20 target vessels without migration, although organ ischemia was noted in one case, indicating the importance of proper placement within the target vessel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel endovascular occlusion device with a steerable introducer for embolization in a porcine model. Lu, W., Fu, W., Si, Y., et al.[2016]

Splenic artery embolization (SAE) was successfully performed on a 52-year-old male with a grade IV splenic injury and significant cardiac issues, demonstrating its effectiveness as a life-saving intervention in complex cases.

Despite the patient's unstable cardiac condition and anticoagulant therapy, the procedure was well-tolerated, allowing for a quick recovery and discharge just three days post-embolization, highlighting the safety and efficacy of SAE in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of a delayed, post-traumatic rupture of splenic artery pseudoaneurysm in a patient with life threatening co-morbidities: A treatment challenge. Kumari, M., Parwez, M., Jain, A., et al.[2020]

In a study of 22 patients with blunt splenic injury, splenic artery embolization demonstrated a high splenic salvage rate of 91%, indicating its effectiveness in preserving the spleen and avoiding splenectomy.

The procedure had a relatively low complication rate, with 41% of patients experiencing complications, primarily left pleural effusion, and no reported mortality, suggesting it is a safe adjunctive treatment for managing splenic injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early embolization in the non-operative management of blunt splenic injuries: a retrospective multicenter study]. Brugère, C., Arvieux, C., Dubuisson, V., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of endovascular coils and vascular plugs for proximal splenic artery embolization in high-grade splenic trauma. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Vascular plugs are associated with reduced fluoroscopy times compared to endovascular coils in proximal splenic artery embolization in trauma. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Utility of the Amplatzer Vascular Plug in splenic artery embolization: a comparison study with conventional coil technique. [2011]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Amplatzer vascular plug for proximal splenic artery embolization. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis of Intraprocedural Comparative Effectiveness of Vascular Plugs Vs Coils in Proximal Splenic Artery Embolization and Associated Patient Radiation Exposure. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A novel endovascular occlusion device with a steerable introducer for embolization in a porcine model. [2016]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Management of a delayed, post-traumatic rupture of splenic artery pseudoaneurysm in a patient with life threatening co-morbidities: A treatment challenge. [2020]

8. France pubmed.ncbi.nlm.nih.gov

[Early embolization in the non-operative management of blunt splenic injuries: a retrospective multicenter study]. [2022]