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Tests treatment safety and results for Iliac Aneurysm
Official title iHub Stent-Graft for Iliac Artery Aneurysms: Safety, Performance, and Effectiveness Study
ClinicalTrials.gov ID: NCT07005141
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate the safety, performance, and Preliminary effectiveness of the iHub endoprosthesis system in treating iliac artery aneurysms in adult patients requiring endovascular repair. The study population includes both male and female adults over 18 years of age who meet the inclusion criteria for endovascular treatment of iliac artery aneurysms.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Sign the Informed Consent Form (ICF); Are ≥ 18 years of age; Meet at least one of the following criteria for iliac artery aneurysm:
- Common iliac artery aneurysm ≥ 25 mm in diameter;
- Aneurysm growth of 5 mm or more within the last six months;
- Maximum aneurysm diameter exceeds 1 to 1.5 times the normal arterial segment diameter, that is ≥ 25 mm maximum diameter;
- Saccular aneurysm greater than 20 mm;
You likely can't join if
- 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;
See the full eligibility criteria
- Sign the Informed Consent Form (ICF); Are ≥ 18 years of age; Meet at least one of the following criteria for iliac artery aneurysm:
- Common iliac artery aneurysm ≥ 25 mm in diameter;
- Aneurysm growth of 5 mm or more within the last six months;
- Maximum aneurysm diameter exceeds 1 to 1.5 times the normal arterial segment diameter, that is ≥ 25 mm maximum diameter;
- Saccular aneurysm greater than 20 mm;
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Florianópolis, Santa Catarina, Brazil
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Florianópolis, Santa Catarina, Brazil; São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.