Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA

Official title

A Prospective, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA in the Open Repair of Aortic Arch Aneurysms and Dissections

Overview

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.

Interventions

• Device Arcevo™ LSA Hybrid Stent Graft System
  The Arcevo LSA Hybrid Stent Graft System is an implantable aortic stent graft with LSA branch which is preloaded onto a delivery system and implanted during an open surgical procedure, or more specifically a total arch replacement procedure. The device is intended for use with a proximal surgical graft (not supplied). If additional coverage is needed, a protocol specified thoracic endovascular aortic repair (TEVAR) device may be used.

Primary outcome measures

• Composite Rate of Patients Free From ≥1 Major Adverse Event [Time frame: 1 year post-index procedure of LSA stent graft implant]

Secondary outcome measures (10)

• Rate of Mortality [Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure]
• Rate of Patients with ≥1 Additional Aortic Procedure [Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure]
• Rate of Patients with ≥1 Device-Related Event [Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure]
• Rate of Patients with Major Adverse Events [Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure]
• Rate of Patients with Radiographic Events (determined by Core Lab) [Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure]
• Rate of Patients Requiring a Thoracic Extension Procedure who Experience Device-Extension Failure [Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure]
• Rate of Patient Requiring a Thoracic Extension Procedure with Evidence of Type IIIa Endoleak [Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of index procedure]
• Rate of Patients Requiring Thoracic Extension Procedure with Failed Patency [Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure]
• Rate of Patients Requiring Thoracic Extension Procedure with ≥1 Primary Major Adverse Events [Time frame: 30 days post-extension procedure]
• Rate of Patients Requiring Thoracic Extension Procedure Requiring ≥1 Secondary Procedure Related to Extension [Time frame: 30 days post-extension procedure]

Eligibility criteria

General 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 21 centers

• University of Alabama — Birmingham
• University of Southern California — Los Angeles
• University of Colorado Hospital — Aurora
• MedStar Washington Health — Washington D.C.
• University of Florida-Shands — Gainesville
• Emory University School of Medicine — Atlanta
• Northwestern University Feinberg School of Medicine — Chicago
• Johns Hopkins Hospital — Baltimore
• … and 13 more centers

Identifiers

NCT: NCT07089576 · ART2401.000-C

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗