Is NCT07089576 recruiting in Aurora, CO?

Yes, NCT07089576 is currently recruiting participants at its Aurora, CO location. This aortic arch aneurysm clinical trial is actively enrolling qualified participants.

How do I join the aortic arch aneurysm clinical trial in Aurora?

To join this clinical trial in Aurora, 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 Aurora 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 Arch Aneurysm Clinical Trial in Aurora, CO

About This Aortic Arch Aneurysm Study in Aurora

The goal of this clinical trial is to learn if the Arcevo LSA stent graft can safely and effectively treat patients that have an acute or chronic aortic dissection and/or aneurysm that involves the aortic arch and the descending thoracic aorta, with or without the involvement of the ascending aorta.

Sponsor: Artivion Inc.

Who Can Participate

Inclusion Criteria

≥18 years of age or ≤80 years of age (male or female) at time of surgery

Patient has one of the following indications for open surgery based on computed tomography angiography (CTA) completed within 90 days of informed consent:

Acute, subacute, or chronic dissection that involves the aortic arch and the descending thoracic aorta, with or without involvement of the ascending aorta

Aneurysm that involves the aortic arch and the descending thoracic aorta, with or without involvement of the ascending aorta

Patient, or patient's legally authorized representative (LAR; in the secondary arm only), provides written informed consent prior to any study procedures

Patient's surgery occurs within 90 days of informed consent Anatomical Inclusion Criteria

Aortic diameter at the intended Arcevo™ LSA anastomosis site is ≥ 21 mm

For Aneurysm with distal sealing (i.e., single stage procedure), aortic diameter at the intended distal sealing zone is between 20-36 mm

For Dissection with distal sealing, aortic diameter at the intended distal sealing zone is between 22-40 mm

LSA branch does not require additional stenting further into the LSA (beyond the Arcevo™ LSA)

The intended LSA sealing zone has a diameter between 8.5 mm and 14.0 mm with a length of at least 10 mm

Absence of dissection, aneurysm, or stenosis in the intended LSA sealing zone

The intended LSA branch position does not interrupt flow to any branch vessel (e.g., left vertebral artery)

Patient does not have computed tomography (CT) evidence of extreme arch or LSA angulation precluding safe passage of the Arcevo™ LSA and delivery system

LSA take-off angle between 15° and 90°

For patients requiring planned extension, there is a ≥ 2 cm distal seal zone for the TEVAR device without a severely angulated descending aorta

For patients requiring planned extension, patient has suitable iliac artery anatomy for safe passage of the TEVAR delivery system General

Exclusion Criteria

Patient is pregnant, or planning to become pregnant during the course of the study; individuals of child-bearing potential must agree to use acceptable methods of contraception during the study

Patient has another medical condition (aside from the arch disease) that, in the opinion of the investigator, reduces the patient's life expectancy to \< 2 years

Patient has an existing aortic stent graft device in the descending aorta that would interact with Arcevo™ LSA

Patient has a medical, social, or psychological problem that, in the opinion of the investigator, could impede the patient's ability to return for follow-up

Patient is unwilling or unable to comply with the follow-up schedule

Patient is institutionalized due to administrative or judicial order

Patient is unwilling to accept blood transfusion or blood product

Patient is currently participating in another interventional clinical study which includes treatment with another investigational product (e.g., device, pharmaceutical or biologic) Medical Exclusion Criteria

Patient is unfit for open surgical repair involving circulatory arrest

Patient is in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR) or substantial inotropic support prior to surgery

Patient has an active systemic infection

Patient has endocarditis or active infection of the aorta

Patient has a freely ruptured aorta

Patient has a history of a bleeding disorder (e.g., hemophilia)

Patient has current end-stage renal disease (e.g., GFR \<30 mL/min)

Patient has a known allergy to Arcevo™ LSA components and TEVAR device components (if required) (nitinol, polyester, platinum-iridium, or polyethylene)

Patient has uncontrollable anaphylaxis to iodinated contrast or other inability to obtain CT angiograms during follow-up

Patient has acute coronary malperfusion

Patient has symptomatic visceral malperfusion

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 Aurora?

Yes, this clinical trial (NCT07089576) has an active research site in Aurora, 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.

Aortic Arch Aneurysm Treatment Options in Aurora, CO

If you're searching for aortic arch aneurysm treatment options in Aurora, CO, this clinical trial (NCT07089576) 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 Aurora research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aortic arch 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 arch aneurysm clinical trials near you to find additional studies recruiting in your area.

Aortic Arch Aneurysm Clinical Trial in Aurora, CO

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