Is NCT07064460 recruiting in Durham, NC?

Yes, NCT07064460 is currently recruiting participants at its Durham, NC location. This aortic disorders clinical trial is actively enrolling qualified participants.

How do I join the aortic disorders clinical trial in Durham?

To join this clinical trial in Durham, 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 Durham 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 Disorders Clinical Trial in Durham, NC

About This Aortic Disorders Study in Durham

The purpose of this study is to see if physician modified endovascular grafts (PMEG) can be used safely for the treatment of aortic disorders. The surgeon will modify a commercially available graft tailored to the participant's anatomy for surgery. The researchers will follow participants for 5 years, which will require regular visits to the clinic for follow-up imaging and follow-up blood tests.

Sponsor: Chandler Long, MD

Who Can Participate

Inclusion Criteria

A participant may be entered into the study if the participant has at least one of the following: An aneurysm with a maximum diameter of \> 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e, perpendicular to the centerline) measurements; Aneurysm with a history of growth \> 0.5 cm in 6 months; Saccular aneurysm deemed at significant risk for rupture; Symptomatic aneurysm; Ruptured aneurysm AND

Extent of aorta to be treated: juxtarenal, pararenal that include 1 or 2 renal and/or accessory renal arteries, paravisceral that includes celiac artery and/or superior mesenteric artery, and/or thoracoabdominal

High risk of morbidity and mortality with open surgical repair as defined by: a. Anatomic Criteria (Previous abdominal surgery; Previous thoracotomy; Previous aortic surgery) b. Physiologic Criteria (ASA Category III or higher; Age \>70 years; Previous myocardial infarction, coronary artery disease, or coronary artery stent; Coronary stress test with a reversible perfusion defect; Congestive heart failure (CHF); Chronic obstructive pulmonary disease (COPD))

Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit

Nonaneurysmal aortic segment proximal to the aneurysm (neck) with a minimum neck length of 25 mm (Diameter in the range of 18 mm - 42 mm; Angle less than 60o relative to the axis of the aneurysm; Angle less than 60o relative to the axis of the suprarenal aorta);

Minimum branch vessel diameter greater than 5 mm

Iliac artery distal fixation site greater than 20 mm in length and diameter in the range of 9 mm - 21 mm (for use of ZFEN)

Contralateral iliac artery distal fixation site greater than 20 mm in length and diameter in the range of 7.5 mm - 20 mm.

Age: ≥ 18 years old

Life expectancy: \> 2 years

Exclusion Criteria

GENERAL EXCLUSION CRITERIA:

Able to be treated in accordance with the instructions for use with a currently marketed endovascular prosthesis

Unwilling to comply with the follow-up schedule

Inability or refusal to give informed consent by subject or legal representative

Pregnant or breastfeeding

Prefers to receive treatment at another hospital with access to a non-physician modified endovascular prosthesis

Refusal of blood transfusions for religious or personal reasons

Participation in another investigational clinical or device trial, with the exception of another investigational endovascular stent-graft protocol or percutaneous aortic valve protocol, not encompassed by the IDE protocol and performed remotely from the fenestrated procedure (\> 30 days). Examples include remote (\>30 days) participation in a thoracic, abdominal or iliac branch device trial, or participation in a percutaneous aortic valve trial.

Mycotic aneurysm or evidence of active systemic infection MEDICAL EXCLUSION CRITERIA:

Known sensitivities or allergies to the materials of construction of the devices, including nitinol (nickel, titanium), polyester, polypropylene, gold, stainless steel, and/or solder (tin, silver).

Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed

Uncorrectable coagulopathy

Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment • Morbid obesity (BMI ≥ 40 or BMI 30-39.9 with comorbidities)

Major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \< 30 days of the endovascular repair

Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)

Baseline creatinine greater than 2.0 mg/dL

History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)

Deemed a high risk due to significant comorbidities, adjudicated by severity according to the Society for Vascular Surgery reporting standards for endovascular aortic repair involving the renal-mesenteric arteries ANATOMICAL EXCLUSION CRITERIA:

Thrombus or excessive calcification within the neck of the aneurysm

Presence of significant thrombus and/or excessive calcification within the intended proximal or distal seal zone of the aneurysm.

Branch stenosis \> 75% (if left untreated)

Anatomy that would not allow maintenance of at least one patent hypogastric artery

Inadequate femoral or iliac access to accommodate the required delivery systems.

Requirement for iliac conduit in cases of inadequate femoral/iliac access

Absence of a suitable non-aneurysmal segment of distal thoracic aorta and significant aortic tortuosity.

Target vessel anatomy not compatible with fenestrated or branched stent graft incorporation, including vessels with severe stenosis, tortuosity and/or insufficient size to accommodate stent graft placement.

Early target vessel bifurcation precluding safe or effective stent graft placement.

Unsuitable iliac artery fixation site and/or anatomy for iliac limb extension or iliac branch device placement, as defined by the device instructions for use Note: Patients with life-threatening aortic disease who have no acceptable surgical or endovascular alternatives will be allowed to receive treatment under this IDE in the non-statistical cohort Non-statistical Cohort This cohort will include patients who meet the inclusion criteria and meet any of the above exclusion criteria\

with the exception of the following:

Able to be treated in accordance with the instructions for use with a currently marketed endovascular prosthesis

Subject prefers to receive treatment at another hospital with access to a custom-made endovascular prosthesis

Refusal to give informed consent by the subject or legal representative. Note: Inability to consent prior to surgery will not be exclusionary if it is for life-saving measures.

Known sensitivities or allergies to the materials of construction of the devices will be allowed in a life-threatening situation where the patient would not survive open surgery.

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 Durham?

Yes, this clinical trial (NCT07064460) has an active research site in Durham, NC 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 Disorders Treatment Options in Durham, NC

If you're searching for aortic disorders treatment options in Durham, NC, this clinical trial (NCT07064460) 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 Durham research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aortic disorders 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 disorders clinical trials near you to find additional studies recruiting in your area.

Aortic Disorders Clinical Trial in Durham, NC

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