Super-Strength balloon aims to keep dialysis lifelines open
NCT ID NCT07330817
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests a new ultra-high-pressure balloon designed to widen narrowed blood vessels in people on dialysis. About 35 participants will receive the balloon treatment to see if it safely restores blood flow and improves dialysis access. The goal is to fix the narrowing without causing serious side effects within the first month.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Feb 2026
An estimate. Start dates often move.
- Expected to finish
-
Feb 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients able to understand the purpose of the study, voluntarily agree to participate and signed Informed Consent form * Patients with impaired haemodialysis access due to narrowed lesions, as indicated by contrast or ultrasound or clinical diagnosis. * Indications for percutaneous endovascular therapy with diameter stenosis \>50% and fistula's hemodynamic showing abnormalities (thrombosis in the AVF, high venous pressure, re-circulation, abnormal physical examination, decrease in dialysis efficiency, decrease in blood flow through the vascular access) * Target lesion is a resistant de novo or restenotic lesion * The target lesion is located in the reflux vein from the anastomotic site of arteriovenous fistula (AVF) to the distal end of the subclavian vein (excluding the anastomotic site of AVF); if there are no target lesions, they should be treated with standard angioplasty balloon before treating the target lesion. Exclusion Criteria: * Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study; * Patients who are actively participating in another drug or device investigational study, who have not completed the primary endpoint follow-up period; * Patients who have undergone major surgical procedures (such as open chest surgery, head surgery) within 30 days before being enrolled in the study; * Patients who plan to undergo major surgical procedures (such as open chest surgery, head surgery) within 30 days after being enrolled in the study; * Immature AVF (not used for dialysis; due to insufficient inner diameter, inability to ensure successful puncture, and inadequate blood flow, this access has not been used for successful dialysis); * AVF has been implanted with a stent.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Arterio-venous fistula are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
ASST Sette Laghi
Varese, 21100, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New device aims to keep dialysis fistulas working longer
- Massive study explores safety of Office-Based blood vessel procedures
- New device aims to seal brain blood vessel leaks in kids
- New stent shows promise for dialysis patients with blocked fistulas
- Tiny trial tests best way to create dialysis access