Is NCT01874197 recruiting in Seattle, WA?

Yes, NCT01874197 is currently recruiting participants at its Seattle, WA location. This thoracoabdominal aortic aneurysm, without rupture clinical trial is actively enrolling qualified participants.

Is participation in this Seattle 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.

Thoracoabdominal Aortic Aneurysm, Without Rupture Clinical Trial in Seattle, WA

Q: How do I join the thoracoabdominal aortic aneurysm, without rupture clinical trial in Seattle?

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

About This Thoracoabdominal Aortic Aneurysm, Without Rupture Study in Seattle

An investigator-initiated, prospective, consecutively enrolling, non-randomized single institution clinical evaluation of the safety and effectiveness of branched and fenestrated-branched endovascular stent grafts to preserve branch vessels when used in the treatment of patients with thoraco-abdominal aortic aneurysms. The study evaluates non-FDA-approved off the shelf and custom made branched and fenestrated-branched stent grafts manufactured by Cook Medical. The primary objectives of this study are to determine whether fenestrated-branched and branched endovascular grafts are a safe and effective method of treating patients with thoraco-abdominal aortic aneurysms.

Sponsor: University of Washington

Who Can Participate

Inclusion Criteria

All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:

Patient is \> 18 years of age

Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)

Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form

Patient is considered by the treating physician to be at high risk of open surgical repair due to one or more major medical co-morbidities (i.e. CAD, CHF, COPD, CRI, advanced age, generalized deconditioning, or other.) with ASA of 3 or more.

The patient has a life expectancy of greater than 1 year.

The patient has a thoraco-abdominal aortic aneurysm where necessary visceral branch vessels (i.e. the celiac, superior mesenteric, inferior mesenteric, renal and/or dominant spinal arteries) arise from the aneurysm or seal zones necessary for on-label thoracic endovascular repair

Patient has a thoraco-abdominal aortic aneurysm that meets at least one of the following:

aneurysm \> 5.5 cm in diameter

aneurysm has increased in size by 0.5 cm in last 6 months

aneurysm is believed to be causing symptoms

Patient has sufficient arterial access (femoral and/or iliac) that will allow delivery of the endovascular device with or without the use of a surgical conduit.

Patient has suitable proximal (aorta) and distal (aorta or iliac) arteries to allow for adequate fixation and seal: A. Non-aneurysmal proximal aortic seal zone:

with a length of 25 mm of proximal seal in non-aneurysmal aorta, with or without coverage of the left subclavian artery,

with an outer wall diameter of no less than 20 mm and no greater 38mm, and B. Non-aneurysmal distal aortic or iliac landing zone:

With a length of at least 15 mm,

Aortic seal zone no less than 15 mm and no greater than 38 mm or Iliac seal zone with an outer wall diameter of no less than 8 mm and no greater than 23 mm. 10\. The patient has no more than 5 necessary visceral arteries that require flow preservation. 11\. All target visceral artery seal zones are \> 4 mm in diameter. 12. Patient must be willing to comply with all required follow-up exams.

Exclusion Criteria

Patients that meet ANY of the following are not eligible for enrollment into the study:

Patient has an active systemic infection

Patient has a mycotic aneurysm.

Patient has a known hypersensitivity to contrast media that is not amenable to pre-treatment.

Patient has an absolute contra-indication to anticoagulation

Patient has a known allergy or intolerance to stainless steel, nickel, or gold

Patient has a body habitus that would inhibit adequate X-ray visualization of the aorta

Patient has a dominant artery to the spinal cord arising from an area of stent graft coverage that is not amenable to preservation using an endovascular branch

Patient is currently participating in another investigational device or drug clinical trial

Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.

Patient has a freely ruptured TAAA with hemodynamic instability

Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)

Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned within 30 days of the TAAA repair. Adjunctive procedures for treatment of the TAAA (i.e. carotid-subclavian bypass or iliac conduit) are acceptable.

Patient has a history of connective tissue disease (e.g. Marfan or Ehlers Danlos syndromes)

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 Seattle?

Yes, this clinical trial (NCT01874197) has an active research site in Seattle, WA 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.

Thoracoabdominal Aortic Aneurysm, Without Rupture Treatment Options in Seattle, WA

If you're searching for thoracoabdominal aortic aneurysm, without rupture treatment options in Seattle, WA, this clinical trial (NCT01874197) 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 Seattle research site is actively enrolling participants for this clinical trial. You'll receive care from experienced thoracoabdominal aortic aneurysm, without rupture 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 thoracoabdominal aortic aneurysm, without rupture clinical trials near you to find additional studies recruiting in your area.

Thoracoabdominal Aortic Aneurysm, Without Rupture Clinical Trial in Seattle, WA

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