Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA

Not Applicable

Not yet recruiting

• Conditions: Aortic Arch Aneurysm; Aortic Arch Dissection; Chronic Aortic Dissection; Acute Aortic Dissection

• Registration Number: NCT07089576
• Lead Sponsor: Artivion Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-17
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Study Start: 2025-09-01
• Primary Completion: 2028-03
• Study Completion: 2032-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Composite Rate of Patients Free From ≥1 Major Adverse Event	1 year post-index procedure of LSA stent graft implant	The major adverse events included in the composite are: * All-cause mortality; * New permanent disabling stroke; * New permanent paraplegia and/or paraparesis; * Unanticipated aortic reoperation in the treated segment; * LSA occlusion

Secondary Outcome Measures

Name	Time	Method
Rate of Patients with ≥1 Additional Aortic Procedure	Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure	All unplanned aortic procedures (endovascular, percutaneous, and open), Unanticipated aortic reoperations in the treated segment, Unanticipated device-related reoperations, Arcevo LSA explant
Rate of Mortality	Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure	All-cause, Cardiovascular-related, Aorta-related, Procedure-related, Device-related
Rate of Patients with ≥1 Device-Related Event	Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure	Device migration, Distal stent-induced new entry (d-SINE), Failed stent patency in the main body, Failed stent patency in the LSA, Stent-graft integrity issue compromising flow (i.e., stent fracture, narrowing, kink, or twist)
Rate of Patients with Major Adverse Events	Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure	New permanent paraplegia, New permanent paraparesis, New temporary paraplegia, New disabling stroke, New non-disabling stroke, New transient ischemic attack, Aortic rupture, Bowel ischemia, Hypersensitivity, Myocardial infarction, New onset renal failure requiring temporary dialysis, New onset renal failure requiring permanent dialysis, Pseudoaneurysm, Recurrent laryngeal or phrenic nerve injury, Respiratory failure (need for reintubation or ventilator dependence \>48 hours), Severe heart failure requiring mechanical circulatory support, Thromboembolic adverse events
Rate of Patients with Radiographic Events (determined by Core Lab)	Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure	Anastomotic Leak between Arcevo™ LSA and surgical graft (i.e., Type Ia Endoleak or Distal anastomotic new entry \[DANE\]), Type Ic Endoleak (i.e. at the end of the LSA stent component), LSA occlusion, New LSA dissection, Maximal total aortic diameter growth \>1 cm in the treated segment (Zones 2-4) compared to first post-operative CTA, Maximal total aortic diameter growth \>1 cm at 1 cm beyond the distal end of Arcevo™ LSA, compared annually.; Dissection Only: True lumen (TL) reduction compared to baseline \> 5.0 mm at maximal total aortic diameter (Zones 2-4), False lumen (FL) growth compared to baseline \> 5.0 mm at maximal total aortic diameter (Zones 2-4), FL thrombosis in the treated segment (LSA, Zones 2-4), FL thrombosis in the untreated segment (Zone 5).
Rate of Patients Requiring a Thoracic Extension Procedure who Experience Device-Extension Failure	Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure	Any failure of device-extension integrity (e.g., wear or tear in the fabric or wire breakage) resulting in a compromised seal and blood leakage or movement of the device
Rate of Patient Requiring a Thoracic Extension Procedure with Evidence of Type IIIa Endoleak	Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of index procedure	Type IIIa Endoleak
Rate of Patients Requiring Thoracic Extension Procedure with Failed Patency	Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure	Failed patency of the device-extension overlap
Rate of Patients Requiring Thoracic Extension Procedure with ≥1 Primary Major Adverse Events	30 days post-extension procedure	All-cause mortality, new permanent disabling stroke, new permanent paraplegia and/or paraparesis, unanticipated aortic reoperation in the treated segment, LSA occlusion
Rate of Patients Requiring Thoracic Extension Procedure Requiring ≥1 Secondary Procedure Related to Extension	30 days post-extension procedure	Secondary procedures related to the extension

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States