Is NCT02050113 recruiting in Worcester, MA?

Yes, NCT02050113 is currently recruiting participants at its Worcester, MA location. This complex aortic aneurysms clinical trial is actively enrolling qualified participants.

How do I join the complex aortic aneurysms clinical trial in Worcester?

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

Is participation in this Worcester 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.

Complex Aortic Aneurysms Clinical Trial in Worcester, MA

About This Complex Aortic Aneurysms Study in Worcester

The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.

Sponsor: Andres Schanzer

Who Can Participate

Inclusion Criteria

A patient may be suitable for inclusion in the study if the patient has at least one of the following:

Aortic or aortoiliac aneurysm with diameter ≥5.5 cm

Aortic or aortoiliac aneurysm with a history of growth ≥1.0 cm per year, or clinical indication for aneurysm repair based on symptoms General Inclusion Criteria

Cannot be treated with a currently available non-modified approved device

Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device

At least 18 years of age

Not pregnant or breastfeeding

Willing and able to comply with five years of follow-up

Willing and able to provide informed consent prior to enrollment

No systemic or local infection that may increase the risk of endovascular graft infection

High risk for open surgical repair based on any of the factors below: a. Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery b. Physiologic i. ASA Category III or higher ii. Age \>70 years iii. Previous myocardial infarction, coronary artery disease, or coronary artery stent iv. Coronary stress test with a reversible perfusion defect v. Congestive heart failure vi. COPD

Exclusion Criteria

Cultural objection to receipt of blood or blood products

Allergy or sensitivity to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol

Anaphylactic reaction to contrast that cannot be adequately pre-medicated

Uncorrectable coagulopathy

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 active malignancy with life expectancy of less than 2 years

Patient has life expectancy less than two years Anatomical Exclusion Criteria

Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access

Proximal neck length ≤25 mm

Proximal neck, measured outer wall to outer wall on a sectional image (CT)

For use of Zenith Flex: diameter \>32 mm or \<18 mm

For use of Zenith TX2: diameter \>38 mm or \<24 mm (for proximal and distal neck diameter)

Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm

Proximal neck diameter change over the length of the proximal seal zone \>4 mm

Proximal seal site with a circumferential thrombus/atheroma

Iliac artery diameter, measured inner wall to inner wall on a sectional image (CT) \<7.0 mm at any point along access length (prior to deployment)

Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional image (CT) \>21 mm at distal fixation site

Iliac artery distal fixation site \<10 mm in length

Non-bifurcated segment of any artery to be stented \< 15 mm in length

Artery to be stented with a maximum diameter \<3 mm or \>10 mm at the vessel ostium

Inability to maintain at least one patent hypogastric artery

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 Worcester?

Yes, this clinical trial (NCT02050113) has an active research site in Worcester, MA 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.

Complex Aortic Aneurysms Treatment Options in Worcester, MA

If you're searching for complex aortic aneurysms treatment options in Worcester, MA, this clinical trial (NCT02050113) 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 Worcester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced complex aortic aneurysms 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 complex aortic aneurysms clinical trials near you to find additional studies recruiting in your area.

Complex Aortic Aneurysms Clinical Trial in Worcester, MA

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