Is NCT06501872 recruiting in Lebanon, NH?

Yes, NCT06501872 is currently recruiting participants at its Lebanon, NH location. This aortic aneurysm clinical trial is actively enrolling qualified participants.

How do I join the aortic aneurysm clinical trial in Lebanon?

To join this clinical trial in Lebanon, 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 Lebanon 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 Clinical Trial in Lebanon, NH

About This Aortic Aneurysm Study in Lebanon

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: Bjoern D. Suckow

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 judgement of the Investigator, to be a high- risk candidate for open surgical repair

Must commit to comply with the five-year study assessment schedule of events

Must have a non-aneurysm-related life expectancy, in the judgement of the Investigator, of greater than 2 years Expanded Selection 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. The aneurysm must not extend proximal to the left subclavian artery, or, in the setting of more proximal disease, that disease must have been previously treated.

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 Investigator, has aneurysm characteristics that portend a high risk of near-term rupture

In the setting of an aortic dissection the following criteria must exist:

Access into the true lumen from the groin and at least one supra-aortic trunk vessel

A sealing zone in the target aorta (or surgical graft) that is proximal to the primary dissection, such that a stent graft would be anticipated to seal off the dissection lumen

A sealing zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen, or surgically created

A true lumen size large enough to deploy the device and still gain access into the target branches

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

Patient must be able to provide informed consent

Must commit to comply with the five-year study assessment schedule of events

Must have a non-aneurysm-related life expectancy, in the judgement of the Investigator, 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 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 - Ability to bear children

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

Candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft

Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution. Expanded Selection 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 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

Ability to bear children

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

Candidate for repair under the Instructions for Use of a commercially available, FDA- approved endovascular graft

Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution

Other conditions or comorbidities that, in the opinion of the Investigator, 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 Lebanon?

Yes, this clinical trial (NCT06501872) has an active research site in Lebanon, NH 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 Treatment Options in Lebanon, NH

If you're searching for aortic aneurysm treatment options in Lebanon, NH, this clinical trial (NCT06501872) 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 Lebanon research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aortic aneurysm 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 clinical trials near you to find additional studies recruiting in your area.

Aortic Aneurysm Clinical Trial in Lebanon, NH

Expert Care in Lebanon

IRB Approved

No-Cost Care

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