New York, NYNCT04503395Now EnrollingIRB Ready

Aortic Aneurysm, Abdominal Clinical Trial in New York, NY

Access cutting-edge aortic aneurysm, abdominal treatment through this clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by FCRE (Foundation for Cardiovascular Research and Education)

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Expert Care in New York

Access aortic aneurysm, abdominal specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related aortic aneurysm, abdominal treatment provided free

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Check if you qualify for this aortic aneurysm, abdominal clinical trial in New York, NY

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Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Aortic Aneurysm, Abdominal Study in New York

The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).

Sponsor: FCRE (Foundation for Cardiovascular Research and Education)

Who Can Participate

Inclusion Criteria

Subject is \>18 years old
Subject is scheduled for primary treatment of the abdominal aortic aneurysm with a non-aneurysmal infrarenal aortic sealing zone proximal to the aneurysm that is sufficiently healthy for a proximal neck length that is at least 4mm and not more than15 mm and has a circumferential minimum sealing zone length of 8 mm
Subject is not a candidate for safe, effective and durable standard EVAR due to challenging anatomical criteria as confirmed by the Core Lab screening
Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
Subject has provided written informed consent CT Angiographic Inclusion Criteria
Subject meets the other anatomical requirements according to the locally applicable Endurant II/IIs stent graft system, Heli-FX EndoAnchor system, Terumo Fenestrated Anaconda (available in EU only) and/or Cook Zenith Fenestrated Graft Instructions for Use
Proximal neck length of the aorta within 4-15mm and a minimum circumferential sealing zone of 8mm
Aortic neck diameter from 19 to 31mm
Infrarenal neck angulation ≤45°

Exclusion Criteria

Subject is participating in a concurrent study which may confound study results
Subject has a life expectancy \<2 year
Subject is female of childbearing potential in whom pregnancy cannot be excluded
Subject with eGFR \<30 mL/min/m2 (KDOQI classification - exclude class IV and above) and or on dialysis
Subject with a MI or CVA within 3 months prior to index procedure
Subject with known Connective Tissue Disease
Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to post-treatment
Subject who has undergone prior endovascular or open surgical treatment for abdominal aortic aneurysm
Subject requires emergent aneurysm treatment, for example, trauma or rupture
Subject has a known hypersensitivity or allergies to study device implant material
Subject has an aneurysm that is:
Suprarenal, pararenal, or thoracoabdominal
Inflammatory
Pseudoaneurysm
Subject is presenting with thrombus or calcification of the proximal aneurysm neck: circumferential \>50%
Pre-op stenosis of the renal arteries \> 50%
Subject has active infection or history of COVID-19. History of COVID-19 is defined as availability of positive COVID-19 test with sequelae or hospitalization for treatment of COVID-19.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT04503395) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Aortic Aneurysm, Abdominal Treatment Options in New York, NY

If you're searching for aortic aneurysm, abdominal treatment options in New York, NY, this clinical trial (NCT04503395) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aortic aneurysm, abdominal specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all aortic aneurysm, abdominal clinical trials near you to find additional studies recruiting in your area.

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