Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA (NCT07089576) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
United States132 participantsStarted 2025-11-04
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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:
✓. 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
✓. 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)
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
What they're measuring
1
Composite Rate of Patients Free From ≥1 Major Adverse Event
Timeframe: 1 year post-index procedure of LSA stent graft implant
✕. 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)