Angioplasty or Stenting for Postural Hypotension

Overseen By Karthikeyan M Arcot, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Francis Hospital, New York

Must not be taking: Blood thinners

Disqualifiers: Pregnancy, Breastfeeding, Infection, Coagulopathy, others

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

Compensation: Varies

Number of Visits: 4

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if angioplasty or stenting (a procedure to open narrowed veins) can benefit individuals who experience dizziness or fainting upon standing due to orthostatic hypotension or orthostatic intolerance. Current medications for these conditions can be difficult to manage and may cause unwanted side effects. The study uses imaging to identify and open narrowed veins near the heart, potentially improving symptoms and blood pressure control. Adults with these conditions who have not improved with standard treatments may be suitable candidates. Participants will undergo follow-ups to assess improvements in symptoms and quality of life after the procedure. As an unphased trial, this study provides a unique opportunity to explore a new treatment option for those who have not found relief with existing therapies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that participants have OH or OI not helped by standard treatments, so you might continue your current meds unless advised otherwise by the study team.

What prior data suggests that this procedure is safe for treating orthostatic hypotension or intolerance?

Research has shown that venous angioplasty and stenting can improve blood pressure and reduce symptoms in people with orthostatic hypotension (OH). In earlier studies, patients achieved better blood pressure control and experienced fewer symptoms, such as dizziness when standing up.

Regarding safety, using stents in veins has proven to be safe. Reports indicate it effectively resolves blood flow issues. Some studies have also highlighted the long-term safety of these procedures. Although rare, risks such as bleeding or infection can occur, but these are carefully monitored.

Overall, current data suggests the treatment is well-tolerated. However, as with any medical procedure, participants should discuss potential risks with their doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using angioplasty or stenting for postural hypotension because these techniques offer a novel approach to treating the condition. Unlike standard treatments, which typically involve medication to manage blood pressure or lifestyle changes, angioplasty or stenting directly targets the veins. This method could enhance blood flow and stability, offering more immediate and potentially longer-lasting relief. By potentially addressing the root cause of blood flow issues, these interventions might provide a new avenue for those who haven't found success with current options.

What evidence suggests that angioplasty or stenting might be an effective treatment for orthostatic hypotension?

Research has shown that venous angioplasty and stenting, a procedure available to participants in this trial, can improve symptoms in people with orthostatic hypotension (OH). Studies have found that after undergoing this procedure, patients gained better control over their blood pressure, experiencing less dizziness and fewer fainting episodes when standing. The treatment widens narrowed veins, facilitating blood flow back to the heart. This method has shown promise in reducing OH symptoms, thereby easing daily activities. ^{1 4 6 7 8}

Who Is on the Research Team?

Karthikeyan M Arcot, MD

Principal Investigator

St. Francis Hospital The Heart Center

Are You a Good Fit for This Trial?

The STAND-UP Study is for adults over 18 with orthostatic hypotension or intolerance that doesn't improve with medication, or worsens when lying down. Participants must be able to give informed consent and take blood thinners. It's not suitable for those who are pregnant, breastfeeding, have an active infection, or can't take blood thinners.

Inclusion Criteria

Able to provide informed consent

I am 18 years old or older.

I have dizziness or fainting when standing that doesn't improve with usual treatment.

Exclusion Criteria

Pregnancy or breastfeeding

I currently have an infection.

I have a bleeding disorder or cannot take blood thinners.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Imaging and Procedure

Participants undergo imaging to check for vein narrowing and, if needed, receive angioplasty or stenting

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits checking symptoms, blood pressure, and quality of life

2 years

Visits at 2-4 weeks, 3 months, 6 months, 1 year, and 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Angioplasty or Stenting

Trial Overview This study tests angioplasty or stenting to open narrowed veins above the heart in patients with autonomic failure conditions like OH/OI. The procedure involves a catheter to widen veins using a balloon or stent under local anesthesia. Follow-ups will assess symptoms and quality of life over two years.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Venous Angioplasty or stenting

Who Is Running the Clinical Trial?

St. Francis Hospital, New York

Lead Sponsor

Trials

9

Recruited

2,300+

Citations

1. mdpi.com mdpi.com/2813-2475/4/4/41

Venous Angioplasty and Stenting as a Novel Therapeutic ... Results: The patients showed improved post-procedural blood pressure and reduced OH symptoms. The average supine-standing systolic disparity decreased from ...

2. researchgate.net researchgate.net/publication/396725683_Venous_Angioplasty_and_Stenting_as_a_Novel_Therapeutic_Strategy_for_Orthostatic_Hypotension_A_Retrospective_Review

Venous Angioplasty and Stenting as a Novel Therapeutic ... Results: The patients showed improved post-procedural blood pressure and reduced OH symptoms. The average supine-standing systolic disparity ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10017898/

Deep venous stenting in females - PMC Deep venous stenting has gained increasing prominence in recent years. This issue focuses on special considerations in female patients.

4. scilit.com scilit.com/publications/dbeb4e4bdd82df97059ebf3008049866

Venous Angioplasty and Stenting as a Novel Therapeutic ... Results: The patients showed improved post-procedural blood pressure and reduced OH symptoms. The average supine-standing systolic disparity ...

5. mdpi.com mdpi.com/2813-2475/4/4/41/review_report

Venous Angioplasty and Stenting as a Novel Therapeutic ... Results: All patients showed improved post-procedural blood pressure and reduced OH symptoms. The average supine-standing systolic disparity decreased from ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2468428724000674

Iliac venous stenting as adjunct in the management of ... Case report. Chronic venous disorders. Iliac venous stenting as adjunct in the management of symptomatic orthostatic hypotension in iliac vein compression.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10424652/

Long‐term safety and efficacy of stenting on correcting internal ... Using stents to correct IH and related neurological issues has shown to be a safe and effective approach for both IJVS and CVSS.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/P180037B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of the VENOVO Venous Stent for the ...