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Tests treatment safety and results for Aortic Arch Aneurysm
Official title Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
ClinicalTrials.gov ID: NCT07089576
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- General 1. ≥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...
- Acute, subacute, or chronic dissection that involves the aortic arch and the descending thoracic aorta, with or without involvement of the ascending...
- 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...
You likely can't join if
- Patient is pregnant, or planning to become pregnant during the course of the study; individuals of child-bearing potential must agree to use...
- Patient has another medical condition (aside from the arch disease) that, in the opinion of the investigator, reduces the patient's life expectancy...
- 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...
- Patient is unwilling or unable to comply with the follow-up schedule
- Patient is institutionalized due to administrative or judicial order
See the full eligibility criteria
Who can join
- General 1. ≥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 5. 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
What rules you out
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Gainesville, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- The Bronx, New York, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Plano, Texas, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Gainesville, Florida, United States; Atlanta, Georgia, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.