Peripheral Arterial HemorrhageNCT04649255

Treatment of Peripheral Arterial Hemorrhage With Lava LES (The LAVA Study)

A study testing Liquid Embolic in people with Peripheral Arterial Hemorrhage, run by BlackSwan Vascular, Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the safety and effectiveness of the Lava LES for the embolic treatment of arterial hemorrhage in the peripheral vasculature. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Arterial Hemorrhage
What is being tested?: Liquid Embolic
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 113 participants
Where: 9 sitesUnited States
Study dates: 14 Apr 2021to 17 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18 years;
Active arterial bleeding in the peripheral vasculature, documented on a suitable imaging study;
Subject or subject's legally authorized representative is able and authorized to provide written informed consent for the procedure and the study;
Subject is willing and able to comply with the specified follow-up evaluation schedule;
Life expectancy >30 days;
No prior embolization in the target territory.

Who cannot join

Pregnancy or breast feeding. A woman who, in the Investigator's opinion, is of child-bearing potential must have a negative pregnancy test within 7 days before the index procedure;
Coexisting signs of peritonitis or other active infection;
Participation in an investigational study of a new drug, biologic or device that has not reached its primary endpoint at the time of study screening;
Uncorrectable coagulopathies such as thrombocytopenia <40,000/ μL, international normalization ratio (INR) >2.0;
Contraindication to angiography or catheterization, including untreatable allergy to iodinated contrast media;
Anatomic arterial unsuitability such that, in the Investigator's opinion, the delivery catheter cannot gain access to the selected position for safe and intended embolization;
Known allergy or other contraindication to any components of Lava LES including dimethyl sulfoxide (DMSO);
More than 4 Target Lesions will require embolization, in the Investigator's opinion after performance of diagnostic angiography or another suitable imaging study.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Albany University Medical Center
Albany, New York, 12208
University of Maryland
Baltimore, Maryland, 21201
University of North Carolina
Chapel Hill, North Carolina, 27599
Rush University Medical Center
Chicago, Illinois, 60612
Indiana University
Indianapolis, Indiana, 46202
University of California
Irvine, California, 92697
University of Southern California
Los Angeles, California, 90033
University of Miami
Miami, Florida, 33136
Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

Official title: Liquid Embolization of Arterial Hemorrhages in the Peripheral Vasculature: The LAVA Study

To evaluate the safety and effectiveness of the Lava LES for the embolic treatment of arterial hemorrhage in the peripheral vasculature.

Conditions: Peripheral Arterial Hemorrhage
Being tested: Liquid Embolic
Keywords: Peripheral Arterial Hemorrhage, Embolic Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Liquid EmbolicDevice
Lava Liquid Embolic System (LES)

Study groups in NCT04649255
Study group	Role	What they receive
Lava LES	Experimental	Not described Receives: Device: Liquid Embolic

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Composite of Freedom From Major Adverse Events (MAEs)
A composite of freedom from 30-day MAEs include ischemia or infarction of the target territory, non-target embolization, allergic reactions to Lava, catheter breakage, and catheter entrapment defined as the inability to withdraw a catheter from adherence to Lava.
Measured: 30 Days
Percentage of Lesions to Achieve Clinical Success
Defined as absence of bleeding from the target lesion after embolization with the Lava LES, without the need for emergency surgery, re-embolization, or other target lesion reinterventions.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Apr 202117 Aug 2022

First posted2 Dec 2020
Study start14 Apr 2021
Primary completion17 Aug 2022
Study completion17 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peripheral Arterial HemorrhageStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04649255
Sponsor's protocol ID: TPR-00913-01.A
Status last verified: Apr 2024
First submitted: 23 Nov 2020
Last updated: 12 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Arterial Hemorrhage trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Liquid Embolization of Arterial Hemorrhages in the Peripheral Vasculature: The LAVA Study
ClinicalTrials.gov ID: NCT04649255
Acronym / sponsor ID: TPR-00913-01.A
Conditions: Peripheral Arterial Hemorrhage
Keywords: Peripheral Arterial Hemorrhage, Embolic Treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 113 participants (actual)
Lead sponsor: BlackSwan Vascular, Inc.Industry (pharma, biotech, devices)
Collaborators: Syntactx
Study start: 14 Apr 2021 (actual)
Primary completion: 17 Aug 2022 (actual)
Study completion: 17 Aug 2022 (actual)
First posted: 2 Dec 2020 (actual)
Results: Posted 12 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the safety and effectiveness of the Lava LES for the embolic treatment of arterial hemorrhage in the peripheral vasculature.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Lava LES	Experimental	Device: Liquid Embolic

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age ≥18 years;
Active arterial bleeding in the peripheral vasculature, documented on a suitable imaging study;
Subject or subject's legally authorized representative is able and authorized to provide written informed consent for the procedure and the study;
Subject is willing and able to comply with the specified follow-up evaluation schedule;
Life expectancy >30 days;

Key exclusion criteria (8 listed)

Pregnancy or breast feeding. A woman who, in the Investigator's opinion, is of child-bearing potential must have a negative pregnancy test within 7 days before the index procedure;
Coexisting signs of peritonitis or other active infection;
Participation in an investigational study of a new drug, biologic or device that has not reached its primary endpoint at the time of study screening;
Uncorrectable coagulopathies such as thrombocytopenia <40,000/ μL, international normalization ratio (INR) >2.0;
Contraindication to angiography or catheterization, including untreatable allergy to iodinated contrast media;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Liquid EmbolicLava Liquid Embolic System (LES)	Device	Lava LES

Primary outcome

Percentage of Participants With Composite of Freedom From Major Adverse Events (MAEs)
Time frame: 30 Days
A composite of freedom from 30-day MAEs include ischemia or infarction of the target territory, non-target embolization, allergic reactions to Lava, catheter breakage, and catheter entrapment defined as the inability to withdraw a catheter from adherence to Lava.
Percentage of Lesions to Achieve Clinical Success
Time frame: 30 days
Defined as absence of bleeding from the target lesion after embolization with the Lava LES, without the need for emergency surgery, re-embolization, or other target lesion reinterventions.

Results and safety

Results posted to the registry on 12 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lava LES	113	103

Primary outcome: Percentage of Participants With Composite of Freedom From Major Adverse Events (MAEs)

Time frame: 30 Days. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Lava LES n = 101
Value	100 (96.4 to 100)

Lava LES: Exact binomial: 96.4 (95% CI 96.4 to 100), p <0.025, One-sided exact binomial test

Population analysed: Analysis based on the intent-to-treat (ITT) population with valid assessment. The baseline number of subjects was 113 but only 101 subjects were administered the assigned intervention (Lava LES), thus 101 subjects were evaluable.

Primary outcome: Percentage of Lesions to Achieve Clinical Success

Time frame: 30 days. Number (95% Confidence Interval). Unit: percentage of lesions

Measure	Lava LES n = 113
Value	94.3 (89.1 to 97.5)

Lava LES: Exact binomial: 89.1 (95% CI 89.1 to 97.5), p <0.025, One-sided exact binomial test

Population analysed: Analysis based on the intent-to-treat (ITT) population with valid assessment.

Adverse events

Time frame: Up to 6 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lava LES	49 of 113 (43.4%)	92 of 113 (81.4%)	9 of 113

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Peripheral Arterial Hemorrhage

Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
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Recruiting
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Peripheral Arterial Hemorrhage, Trauma
RecruitingPhase 4
Comparison of Clopidogrel-based Antiplatelet Agent Treatment and Aspirin Plus Low Dose Rivaroxaban Therapy
Cardiac Event, Coronary Artery Disease
Recruiting
Neurologic Stem Cell Treatment Study
Neurologic Disorders, Nervous System Diseases
RecruitingObservational study
Neurosurgical Outcome Network
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bulent Arslan, MD principal investigator

Rush University Medical Center

Mahmood Razavi, MD principal investigator

St. Joseph Heart and Vascular Center

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Liquid Embolic in people with Peripheral Arterial Hemorrhage, run by BlackSwan Vascular, Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Composite of Freedom From Major Adverse Events (MAEs) (time frame: 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04649255.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.