Is NCT07026877 recruiting in Colorado Springs, CO?

Yes, NCT07026877 is currently recruiting participants at its Colorado Springs, CO location. This abdominal aortic aneurysms (aaa) clinical trial is actively enrolling qualified participants.

Is participation in this Colorado Springs 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.

Abdominal Aortic Aneurysms (AAA) Clinical Trial in Colorado Springs, CO

Q: How do I join the abdominal aortic aneurysms (aaa) clinical trial in Colorado Springs?

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

About This Abdominal Aortic Aneurysms (AAA) Study in Colorado Springs

The goal of this clinical trial is to learn if the Fenestrated TREO Stent-Graft System works to treat abdominal aneurysms in adults. An abdominal aneurysm is a bulge in the main blood vessel (the aorta) which carries blood from the heart, through the chest and abdomen. It will also learn about the safety of Fenestrated TREO Stent-Graft System. The main question it aims to answer is: Can the the Fenestrated TREO Stent-Graft System be used to treat participants with a specific type of abdominal aneurysm called a juxtarenal abdominal aortic aneurysm? Participants will: Have the the Fenestrated TREO Stent-Graft System implanted via an endovascular surgical procedure and visit the hospital for a follow up period of 5 years, for checkups, tests and imaging scans.

Sponsor: Bolton Medical

Who Can Participate

Inclusion Criteria

18 years or older at the time of consent

Life expectancy is greater than 2 years

An abdominal aortic or aorto-iliac aneurysm requiring a fenestrated graft and with morphology suitable for endovascular repair (confirmed by Computed Tomography (CT) with contrast performed within 6 months of planned implant procedure) as follows:

Maximum aneurysm diameter of ≥5.5 cm for male ( ≥5.0 cm for female) or

Maximum AAA diameter exceeding two times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements (or saccular aneurysm that warrants treatment in the opinion of the investigator) or

Aneurysm with a history of growth \> 0.5 cm in 6 months and

Minimum 0 mm of healthy aorta\

below the most inferior renal artery that the physician plans on preserving and no renal artery involvement (juxtarenal aneurysms) or

At least one renal artery involved in the aneurysm and minimum 2 mm below the celiac (suprarenal aneurysms) \*Healthy aorta is defined as segment of aorta with parallel aortic wall with minimal (\<10%) or no difference in diameter and minimal atherosclerotic debris, thrombus, or calcification.

Proximal landing zone:

≥20 mm length

20-32 mm diameter

≤60° angle relative to the axis of the suprarenal aorta

≤60° angle relative to the long axis of the aneurysm

Distal (iliac) landing zone with:

8-13 mm inside diameter/ ≥10 mm length

\>13-20 mm inside diameter/ ≥15 mm length

Distal aortic diameter (above the iliac bifurcation) ≥70% of the sum of the iliac limb graft diameters

Minimum 18 mm aortic lumen diameter at the level of the fenestrations

Pathology that requires maximum 5 fenestrations in the main body

Pathology that requires fenestration a minimum 3 mm apart (edge to edge)

Branch vessels (to be bridged to the fenestrated graft) with:

5-9 mm diameters

≥13 mm distal landing zone (or ≥15 mm if there is a gap between fenestration and target vessel)

Adequate renal function to tolerate contrast-enhanced CTA

Adequate vascular access compatible with required delivery systems

Willingness to comply with the follow-up evaluation schedule documented in a signed informed consent prior to implant

Exclusion Criteria

Pregnant or lactating

Existing endovascular graft in the treated segment intended to be repaired with the Fenestrated TREO Stent-Graft System

Dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician)

Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging.

A branch vessel(s) that is dissected or has significant calcification, tortuosity, thrombus formation that would interfere with bridging stent delivery or sealing (as determined by treating physician)

Severe untreated coronary artery disease and/or unstable angina, significant areas of myocardium at risk (based on coronary angiogram or radionuclide scans), left ventricular ejection fraction \<20%, or recent diagnosis of congestive heart failure (CHF; as determined by treating physician).

Stroke or myocardial infarction within 6 months of the planned treatment date

Chronic obstructive pulmonary disease requiring routine need for oxygen therapy outside the hospital setting (e.g., daily or nightly home use)

Chronic Kidney Disease (CKD) stage ≥3b.\

During Stage 2, patients with severe CKD (stage ≥3b) can be included in the Expanded Access Arm if otherwise eligible.

Active systemic infection or is suspected of having an active systemic infection (e.g., acquired immune deficiency syndrome (AIDS)/human immunodeficiency virus (HIV), sepsis)

Clinical conditions that would severely compromise or impair x-ray visualization of the aorta (as determined by treating physician).

History of an aortopathic connective tissue disease (e.g., Marfan's syndrome)

Mycotic aneurysm

Significant or circumferential calcification or mural thrombus (as determined by treating physician):

in the proximal aortic neck

in the distal iliac landing zone

within the treatment length, which may adversely impact device patency

Cannot receive intraprocedural anticoagulation per the investigator's standard of care, or antiplatelet therapy post-procedurally as per the investigator's standard of care.

Blood coagulation disorder or bleeding diathesis, the treatment for which cannot be suspended pre- and post-repair

An investigational study drug or biologic within 30 days of planned procedure or an investigational device within one year of planned procedure or any other treatment that may interfere with the interpretation of the study results.

Medical, social or psychological issues that the investigator believes may interfere with study treatment or follow-up.

Untreatable allergy or sensitivity to contrast media, nitinol/nickel, Tantalum, Platinum Iridium (PtIr), 316 stainless steel, ePTFE (expanded polytetrafluoroethylene), PTFE (polytetrafluoroethylene) Impregnated polyester fiber, or polyester

Other major surgical or medical intervention within 45 days of the planned procedure or plan to undergo other major surgical or medical intervention within 45 days post implantation (e.g., coronary artery bypass graft (CABG), organ transplantation, renal stenting)

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 Colorado Springs?

Yes, this clinical trial (NCT07026877) has an active research site in Colorado Springs, CO 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.

Abdominal Aortic Aneurysms (AAA) Treatment Options in Colorado Springs, CO

If you're searching for abdominal aortic aneurysms (aaa) treatment options in Colorado Springs, CO, this clinical trial (NCT07026877) 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 Colorado Springs research site is actively enrolling participants for this clinical trial. You'll receive care from experienced abdominal aortic aneurysms (aaa) 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 abdominal aortic aneurysms (aaa) clinical trials near you to find additional studies recruiting in your area.

Abdominal Aortic Aneurysms (AAA) Clinical Trial in Colorado Springs, CO

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