Minimally-Invasive Venogram for Intracranial Venous Hypertension

Overseen By Kimberly Hawley

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Intracranial venous pathology, Severe headaches, BMI > 35, Heart failure, Pregnancy, 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: 1

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand normal pressure levels in the brain's veins. It involves a procedure called a venogram, a special imaging test that shows blood flow in the brain. The trial targets individuals who require a cerebral angiogram (a brain blood vessel check-up) for reasons unrelated to Idiopathic Intracranial Hypertension (IIH), a condition causing headaches and vision problems. Participants should not experience severe headaches or have known brain vein issues. As an unphased study, this trial provides a unique opportunity to contribute to important research on brain health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this venogram is safe for documenting intracranial venous sinus pressures?

Research has shown that venograms, tests that check blood flow in the brain, are generally safe. In a study of 1,466 venograms, only six major problems occurred, indicating the procedure is usually well-tolerated. A venogram is the best method for identifying narrow veins in the brain, helping doctors see where blood flow might be restricted. While every medical procedure carries some risk, the low number of complications in past studies suggests that venograms are usually safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a minimally-invasive venogram as an approach to diagnose and manage intracranial venous hypertension. Unlike traditional methods, which often rely on more invasive procedures or indirect assessments, this venogram offers a direct and detailed examination of the cerebral veins. This technique aims to enhance precision in identifying venous issues without the need for extensive surgical intervention, potentially improving patient comfort and reducing recovery time. By refining the way we visualize and understand venous pressure in the brain, this method could lead to better-targeted treatments and improved outcomes for patients.

What evidence suggests that this venogram is effective for intracranial venous hypertension?

Research has shown that venograms are the best method to check for cerebral venous sinus stenosis (CVSS). CVSS occurs when brain veins narrow, increasing pressure. This pressure can lead to headaches and vision problems. In this trial, participants will undergo a venogram to assess for CVSS. Studies have found that treating this narrowing with venous sinus stenting is safe and effective for many patients. This treatment widens the narrowed veins, reducing pressure and improving symptoms. ^{2 6 7 8 9}

Who Is on the Research Team?

Kyle Fargen, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for individuals who are scheduled for an elective cerebral angiogram and do not have a history of severe daily headaches, idiopathic intracranial hypertension, or a body mass index over 35. It excludes those with heart failure, pulmonary hypertension, intracranial venous pathology, or pregnancy due to radiation risks.

Inclusion Criteria

I am a candidate for a special brain blood vessel imaging test.

Exclusion Criteria

I do not have severe daily headaches or symptoms of high brain pressure.

I have been diagnosed with heart failure or pulmonary hypertension.

You have a body mass index (BMI) higher than 35, which means you are significantly overweight.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants undergo a standard cerebral angiogram followed by the study intervention involving additional catheter insertion and venogram

10 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any immediate complications following the procedure

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Venogram

Trial Overview The study aims to measure normal brain vein pressures during a cerebral angiogram in the interventional radiology suite. This will help understand pressure levels in patients without Idiopathic Intracranial Hypertension (IIH), which causes increased brain pressure and symptoms like headaches.

How Is the Trial Designed?

Group I: Venogram Group Experimental Treatment 1 Intervention

Participants in this group have a scheduled clinically indicated a cerebral angiogram procedure and will undergo a Venogram.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

In a study of 63 patients, those diagnosed with idiopathic intracranial hypertension (IIH) showed significantly higher degrees of transverse sinus stenosis compared to controls, indicating that MR venography (MRV) is a valuable tool for diagnosis.

The proposed stenosis classifying index, with a cut-off value of ≥4, demonstrated high sensitivity (94.7%) and specificity (93.5%) for diagnosing IIH, making it a quick and effective method for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new index for the assessment of transverse sinus stenosis for diagnosing idiopathic intracranial hypertension. Carvalho, GB., Matas, SL., Idagawa, MH., et al.[2022]

In patients with idiopathic intracranial hypertension, measuring cerebral venous sinus pressure revealed that venous hypertension in the superior sagittal and proximal transverse sinuses is caused by raised intracranial pressure rather than an obstruction in the veins themselves.

The study demonstrated that performing a C1-2 puncture to remove cerebrospinal fluid (CSF) immediately resolves the venous hypertension, confirming that the issue is related to pressure rather than a blockage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manometry combined with cervical puncture in idiopathic intracranial hypertension. King, JO., Mitchell, PJ., Thomson, KR., et al.[2019]

In a study of nine patients with idiopathic intracranial hypertension, venous hypertension was consistently observed in the superior sagittal sinus and proximal transverse sinuses, indicating a potential mechanism for increased intracranial pressure.

Cerebral venography revealed varying appearances of the transverse sinus, from smooth narrowing to filling defects, but these abnormalities were not clearly visible on standard venous phase angiography, suggesting that manometry may be a more effective diagnostic tool for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral venography and manometry in idiopathic intracranial hypertension. King, JO., Mitchell, PJ., Thomson, KR., et al.[2019]

Dural sinus venography provided clearer details about the site and extent of tumor invasion in all three patients studied, outperforming MR imaging and arteriography.

Pressure measurements during the procedure helped assess the severity of hemodynamic issues caused by narrowed blood vessels, aiding surgical decisions and confirming the patency of critical sinuses that other imaging methods missed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venography and venous pressure monitoring in dural sinus meningiomas. Halbach, VV., Higashida, RT., Hieshima, GB., et al.[2021]

Cerebral venous sinus thrombosis (CVST) is a rare but important cause of stroke that should be considered when diagnosing intracranial hypertension.

The best diagnostic methods for CVST are CT venogram and MR venography, as standard non-contrast head CT scans may not show abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supine headache and papilledema: A case and review of cerebral venous sinus thrombosis. Pasricha, SV., Bhayana, R., Wu, PE.[2023]

The PrimeWire Prestige pressure guidewire system offers a safe and efficient method for measuring intracranial venous sinus pressure and performing interventions, successfully navigating the complex venous anatomy in patients with idiopathic intracranial hypertension.

This new system simplifies the process compared to traditional microcatheter techniques, providing advantages in terms of speed, accuracy, and potentially lower costs during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venous sinus manometry and intervention using the PrimeWire Prestige pressure guidewire: technique and initial experience. Lopes, DK., Johnson, AK., Tan, LA.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12420681/

Intracranial venous pressures and endovascular outcomes ... Diagnostic cerebral venograms are the gold standard for evaluating cerebral venous sinus stenosis (CVSS). Venous sinus stenting (VSS) and less ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8227267/

Intracranial Venous Hypertension and Venous Sinus Stenting ... Venous sinus stenting (VSS) has emerged as a safe and reliable treatment for a certain population of patients with IIH.

3. ahajournals.org ahajournals.org/doi/10.1161/str.56.suppl_1.DP36

Abstract DP36: Efficacy of Endovascular Treatment for ... Results: Sinus stenting angioplasty was successful in all 38 patients．In all patients venous sinus stenosis was improved after stenting ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875024000081

Challenges in the use of Venous Sinus Stenting ... VSS emerges as a favorable option, with strong clinical outcomes, lower complication rates, and cost-effectiveness.

5. link.springer.com link.springer.com/article/10.1007/s00701-025-06514-7

Clinical indications and patient outcomes of intracranial ... In principle, VSS can be used to treat intracranial venous hypertension secondary to venous outflow obstruction and venous sinus stenosis. A ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12031942/

Clinical indications and patient outcomes of intracranial ... Intracranial venous sinus stenting (VSS) is a minimally invasive endovascular procedure which was initially developed as a therapeutic option ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2162098923010484

Diagnosis and Management of Cerebral Venous Diseases ... In this article, we review several ongoing notions and controversies involving cerebral venous disease and neuro-ophthalmology.

8. ahajournals.org ahajournals.org/doi/10.1161/SVIN.122.000522

Head Elevation, Cerebral Venous System, and Intracranial ... Head elevation benefits ICP control in intracranial hypertension from improved venous outflow via various networks and craniospinal cerebrospinal fluid ...

9. jnis.bmj.com jnis.bmj.com/content/14/1/neurintsurg-2021-017361

Major complications of dural venous sinus stenting for ... Results Six major acute and chronic complications after VSS were selected from a total of 811 VSS procedures and 1466 venograms for IIH.