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New Stent-Graft aims to fix aneurysms without cutting off blood flow

NCT ID NCT07005141

Disease control Sponsor: Archo Medical S.A Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This early trial tests a new device called the iHub stent-graft in 10 adults with iliac artery aneurysms. The device is placed through a small incision to seal off the aneurysm while keeping blood flowing to the internal iliac artery. Researchers will check for serious problems within the first month and monitor how well the device works over a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iHub endovascular iliac branch stent-graft system
What this could lead to
If it works, this could offer a safer, less invasive way to treat iliac aneurysms while keeping blood flow to the internal iliac artery.
What could go wrong
This is a very small early study with only 10 participants, so results may not apply to everyone. The device could fail, cause leaks, or block blood vessels.

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 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Sign the Informed Consent Form (ICF); Are ≥ 18 years of age; Meet at least one of the following criteria for iliac artery aneurysm: 1. Common iliac artery aneurysm ≥ 25 mm in diameter; 2. Aneurysm growth of 5 mm or more within the last six months; 3. Maximum aneurysm diameter exceeds 1 to 1.5 times the normal arterial segment diameter, that is ≥ 25 mm maximum diameter; 4. Saccular aneurysm greater than 20 mm; 5. Abdominal aortic aneurysm with extension into the common iliac arteries of less than 20 mm; Have a previously implanted aorto-bi-iliac stent-graft with branch diameter between 14 and 16 mm; Have iliac/femoral access vessel morphology compatible with vascular access techniques, placement systems, devices, and/or accessories; Are classified as ASA physical status I to III. ASA IV patients may be included if their life expectancy is greater than one year; Are able and willing to comply with follow-up requirements during the 360-day post-implant period. \- Exclusion Criteria: Pregnant women, women of childbearing potential, or breastfeeding women; A dissection, rupture, or complex vascular lesion due to trauma; Need for emergency surgery; Contraindication to angiography; Diffuse atherosclerotic disease in any common iliac artery reducing its diameter to \< 4 mm; Congenital abnormalities where stent placement would obstruct a major artery. Such abnormalities must be assessed prior to treatment; Unstable angina; Class III obesity (BMI ≥ 40 kg/m²) or other clinical conditions that severely limit radiographic visualization of the aorta; Connective tissue disease (e.g., Marfan or Ehlers-Danlos syndrome); Hypercoagulable state; Contraindication to anticoagulation therapy; Acute or chronic renal insufficiency (serum creatinine \> 2.0 mg/dL); Life expectancy of less than one year; Presence of a systemic infection that could increase the risk of endovascular device infection; Known sensitivity or allergy to device materials: expanded polytetrafluoroethylene (ePTFE), fluorinated ethylene propylene (FEP), or nickel-titanium (Nitinol). \-

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm Iliac Aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic aneurysm, abdominal Iliac aneurysm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP

    RECRUITING

    São Paulo, São Paulo, 05403-000, Brazil

  • Instituto de Ensino e Pesquisa Dr. Irineu May Brodbeck - Hospital Baía Sul S/A

    RECRUITING

    Florianópolis, Santa Catarina, 88020210, Brazil

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