iHub Stent-Graft for Iliac Aneurysms: Safety and Performance in Endovascular Repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first‑in‑human study evaluates the safety, technical performance, and preliminary effectiveness of the iHub endoprosthesis for patients with iliac artery aneurysms requiring endovascular repair. Participants undergo a minimally invasive endovascular procedure to implant the device while preserving internal iliac artery flow. Pre‑screening includes clinical exams, labs, and imaging to confirm eligibility. The study focuses on 12‑month patency and sustained aneurysm exclusion with attention to pelvic perfusion and related complications. The investigation is conducted at two Brazilian centers with a single sponsor and no listed collaborators.

Why it matters

Who can join: the full rules

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).

\-

Where it's running

• Instituto de Ensino e Pesquisa Dr. Irineu May Brodbeck - Hospital Baía Sul S/A
  Florianópolis, Santa Catarina, Brazil Recruiting
• Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Grace C Mulatti, PI — Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo- FMUSP
• Study coordinator: Suzan X Lima
• Email: regulatorio@archomedical.com
• Phone: 5548988092141

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remimazolam vs propofol for stable blood pressure during thoracic/abdominal endovascular aortic repair

  This trial tests whether remimazolam keeps blood pressure steadier than propofol during TEVAR or EVAR in adults.

  Recruiting Phase 4 Seoul National University Hospital · Seoul · NCT07806006

• Using AI to measure aortic size from CT scans

  This project will test whether an AI tool called Aorta AIM can automatically measure the aorta on CT scans for adults who have or are being checked for aortic aneurysms.

  Recruiting Aiatella Oy · Chapel Hill, North Carolina and 2 other locations · NCT07438327

• Observational registry for Iliac E-liac Branch Device in treating aortoiliac aneurysms

  This study is looking at how well the Iliac E-liac Branch Device works for treating aortoiliac aneurysms in patients over time.

  Recruiting at 2 sites Federico II University · Bari, BA and 1 other locations · NCT06946381

• Comparing pain relief methods for patients undergoing vascular surgery

  This study is testing whether a single shot of a new pain medication can help people having vascular surgery feel less pain compared to the standard pain relief method.

  Recruiting Phase 4 Hartford Hospital · Hartford, Connecticut · NCT05972018

• Comparing quality of life after different types of aortic aneurysm repair

  This study looks at how different types of surgery for abdominal aortic aneurysms affect the quality of life for patients over three years.

  Recruiting Karolinska University Hospital · Stockholm · NCT05774938

• Comparing two methods for treating wide-neck abdominal aortic aneurysms

  This study is testing whether a new way to repair wide-neck abdominal aortic aneurysms works better than the standard method for patients with this condition.

  Recruiting at 31 sites Rijnstate Hospital · Washington, Arkansas and 35 other locations · NCT05484115

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.