Is NCT02989948 recruiting in New Haven, CT?

Yes, NCT02989948 is currently recruiting participants at its New Haven, CT location. This aortic aneurysm, thoracoabdominal clinical trial is actively enrolling qualified participants.

Is participation in this New Haven clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Aortic Aneurysm, Thoracoabdominal Clinical Trial in New Haven, CT

Q: How do I join the aortic aneurysm, thoracoabdominal clinical trial in New Haven?

To join this clinical trial in New Haven, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Aortic Aneurysm, Thoracoabdominal Study in New Haven

The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft as compared to previously published results of open surgical replacement of the aneurysmal aorta.

Sponsor: Yale University

Who Can Participate

Inclusion Criteria

Must be a man or woman 50 years of age or older by the date of informed consent.

Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian artery.

Must have an aneurysm size that meets standard indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta).

Must be considered, in the judgment of the S-I, to be a high risk candidate for open surgical repair.

Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft.

Must be able to provide informed consent.

Must be able to comply with the five year study assessment schedule of events.

Must have a non-aneurysm-related life expectancy, in the judgment of the S-I, of greater than 2 years. MAIN ARM -

Exclusion Criteria

Aneurysm due to acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic transection.

Ruptured or acutely symptomatic aortic aneurysm.

Known connective tissue disorder.

Imaging demonstrating any of the following:

Lack of 20 mm non-aneurysmal proximal seal zone (zone 3, or zone 2 with a carotid-subclavian bypass or transposition).

Lack of 15 mm non-aneurysmal distal seal zone(s) (aortic, common iliac, or external iliac).

Branch vessel target (renal, superior mesenteric, or celiac) \< 5 mm or \> 10 mm in average diameter.

Untreated left subclavian artery stenosis or occlusion.

Untreated unilateral or bilateral hypogastric artery occlusion.

Signs that the inferior mesenteric artery is indispensable.

Have branching, duplication, aneurysm, or untreatable stenosis of the celiac, superior mesenteric artery, or renal arteries that would preclude implantation of the investigational devices.

Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold.

History of anaphylaxis to contrast, with inability to prophylax appropriately.

Have uncorrectable coagulopathy.

Have unstable angina.

Have a body habitus that would inhibit X-ray visualization of the aorta.

Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤30 days of the endovascular repair.

Known to be participating in any other clinical study which may affect performance of this device.

Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)

Contraindication to oral antiplatelet therapy.

Prisoners or those on alternative sentencing.

Known systemic infection with potential for endovascular graft infection.

Anticipated need for MRI scanning within 3 months of insertion of investigational product.

Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient. EXPANDED ACCESS ARM - Inclusion Criteria

Must be a man or woman 50 years of age or older by the date of informed consent

Must have a thoracic, thoracoabdominal, or abdominal aortic aneurysm that necessitates coverage of one or more visceral vessels (celiac, superior mesenteric, or renals) for establishment of proximal and/or distal seal.

Must have an aneurysm size that meets standard size indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta); or, in the judgment of the S-I, has aneurysm characteristics that portend a high risk of near-term rupture

Must be considered, in the judgement of the S-I, to be a high risk candidate for open surgical repair

Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft

Patient must be able to provide informed consent

Must be able to comply with the five year study assessment schedule of events

Must have a non-aneurysm-related life expectancy, in the judgement of the S-I, of greater than 2 years EXPANDED ACCESS ARM - Exclusion Criteria

Known or suspected mycotic aneurysm

Ruptured aneurysm with hemodynamic instability

Known connective tissue disorder

Imaging demonstrating any of the following:

Lack of 20 mm non-aneurysmal proximal seal zone (in either native aorta, elephant trunk graft, or aortic arch endograft)

Lack of 15 mm non-aneurysmal distal seal zone(s) (in either native aortoiliac vessels, prosthetic aortoiliac grafts, or aortoiliac endografts)

Branch vessel target (renal, superior mesenteric, or celiac) \> 10 mm in average diameter

Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold

History of anaphylaxis to contrast, with inability to prophylax appropriately.

Have uncorrectable coagulopathy

Have a body habitus that would inhibit X-ray visualization of the aorta

Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair

Known to be participating in any other clinical study which may affect performance of this device

Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)

Contraindication to oral antiplatelet therapy

Prisoners or those on alternative sentencing

Known systemic infection with potential for endovascular graft infection

Anticipated need for MRI scanning within 3 months of insertion of investigational product

Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient

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 Haven?

Yes, this clinical trial (NCT02989948) has an active research site in New Haven, CT 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, Thoracoabdominal Treatment Options in New Haven, CT

If you're searching for aortic aneurysm, thoracoabdominal treatment options in New Haven, CT, this clinical trial (NCT02989948) 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 Haven research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aortic aneurysm, thoracoabdominal 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, thoracoabdominal clinical trials near you to find additional studies recruiting in your area.

Aortic Aneurysm, Thoracoabdominal Clinical Trial in New Haven, CT

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