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.
Brief Title
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
800-438-8285
Central Contact Email
ARTIZEN@artivion.com
Completion Date
Completion Date Type
Estimated
Conditions
Aortic Arch Aneurysm
Aortic Arch Dissection
Chronic Aortic Dissection
Acute Aortic Dissection
Eligibility Criteria
General Inclusion Criteria
1. ≥18 years of age or ≤80 years of age (male or female) at time of surgery
2. 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
3. Patient, or patient's legally authorized representative (LAR; in the secondary arm only), provides written informed consent prior to any study procedures
4. Patient's surgery occurs within 90 days of informed consent
Anatomical Inclusion Criteria
5. Aortic diameter at the intended Arcevo™ LSA anastomosis site is ≥ 21 mm
6. For Aneurysm with distal sealing (i.e., single stage procedure), aortic diameter at the intended distal sealing zone is between 20-36 mm
7. For Dissection with distal sealing, aortic diameter at the intended distal sealing zone is between 22-40 mm
8. LSA branch does not require additional stenting further into the LSA (beyond the Arcevo™ LSA)
9. The intended LSA sealing zone has a diameter between 8.5 mm and 14.0 mm with a length of at least 10 mm
10. Absence of dissection, aneurysm, or stenosis in the intended LSA sealing zone
11. The intended LSA branch position does not interrupt flow to any branch vessel (e.g., left vertebral artery)
12. Patient does not have computed tomography (CT) evidence of extreme arch or LSA angulation precluding safe passage of the Arcevo™ LSA and delivery system
13. LSA take-off angle between 15° and 90°
14. For patients requiring planned extension, there is a ≥ 2 cm distal seal zone for the TEVAR device without a severely angulated descending aorta
15. For patients requiring planned extension, patient has suitable iliac artery anatomy for safe passage of the TEVAR delivery system
General Exclusion Criteria
1. 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
2. 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
3. Patient has an existing aortic stent graft device in the descending aorta that would interact with Arcevo™ LSA
4. 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
5. Patient is unwilling or unable to comply with the follow-up schedule
6. Patient is institutionalized due to administrative or judicial order
7. Patient is unwilling to accept blood transfusion or blood product
8. 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
9. Patient is unfit for open surgical repair involving circulatory arrest
10. Patient is in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR) or substantial inotropic support prior to surgery
11. Patient has an active systemic infection
12. Patient has endocarditis or active infection of the aorta
13. Patient has a freely ruptured aorta
14. Patient has a history of a bleeding disorder (e.g., hemophilia)
15. Patient has current end-stage renal disease (e.g., GFR \<30 mL/min)
16. Patient has a known allergy to Arcevo™ LSA components and TEVAR device components (if required) (nitinol, polyester, platinum-iridium, or polyethylene)
17. Patient has uncontrollable anaphylaxis to iodinated contrast or other inability to obtain CT angiograms during follow-up
18. Patient has acute coronary malperfusion
19. Patient has symptomatic visceral malperfusion
1. ≥18 years of age or ≤80 years of age (male or female) at time of surgery
2. 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
3. Patient, or patient's legally authorized representative (LAR; in the secondary arm only), provides written informed consent prior to any study procedures
4. Patient's surgery occurs within 90 days of informed consent
Anatomical Inclusion Criteria
5. Aortic diameter at the intended Arcevo™ LSA anastomosis site is ≥ 21 mm
6. For Aneurysm with distal sealing (i.e., single stage procedure), aortic diameter at the intended distal sealing zone is between 20-36 mm
7. For Dissection with distal sealing, aortic diameter at the intended distal sealing zone is between 22-40 mm
8. LSA branch does not require additional stenting further into the LSA (beyond the Arcevo™ LSA)
9. The intended LSA sealing zone has a diameter between 8.5 mm and 14.0 mm with a length of at least 10 mm
10. Absence of dissection, aneurysm, or stenosis in the intended LSA sealing zone
11. The intended LSA branch position does not interrupt flow to any branch vessel (e.g., left vertebral artery)
12. Patient does not have computed tomography (CT) evidence of extreme arch or LSA angulation precluding safe passage of the Arcevo™ LSA and delivery system
13. LSA take-off angle between 15° and 90°
14. For patients requiring planned extension, there is a ≥ 2 cm distal seal zone for the TEVAR device without a severely angulated descending aorta
15. For patients requiring planned extension, patient has suitable iliac artery anatomy for safe passage of the TEVAR delivery system
General Exclusion Criteria
1. 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
2. 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
3. Patient has an existing aortic stent graft device in the descending aorta that would interact with Arcevo™ LSA
4. 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
5. Patient is unwilling or unable to comply with the follow-up schedule
6. Patient is institutionalized due to administrative or judicial order
7. Patient is unwilling to accept blood transfusion or blood product
8. 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
9. Patient is unfit for open surgical repair involving circulatory arrest
10. Patient is in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR) or substantial inotropic support prior to surgery
11. Patient has an active systemic infection
12. Patient has endocarditis or active infection of the aorta
13. Patient has a freely ruptured aorta
14. Patient has a history of a bleeding disorder (e.g., hemophilia)
15. Patient has current end-stage renal disease (e.g., GFR \<30 mL/min)
16. Patient has a known allergy to Arcevo™ LSA components and TEVAR device components (if required) (nitinol, polyester, platinum-iridium, or polyethylene)
17. Patient has uncontrollable anaphylaxis to iodinated contrast or other inability to obtain CT angiograms during follow-up
18. Patient has acute coronary malperfusion
19. Patient has symptomatic visceral malperfusion
Inclusion Criteria
Inclusion Criteria
1. ≥18 years of age or ≤80 years of age (male or female) at time of surgery
2. 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
3. Patient, or patient's legally authorized representative (LAR; in the secondary arm only), provides written informed consent prior to any study procedures
4. Patient's surgery occurs within 90 days of informed consent
Anatomical Inclusion Criteria
5. Aortic diameter at the intended Arcevo™ LSA anastomosis site is ≥ 21 mm
6. For Aneurysm with distal sealing (i.e., single stage procedure), aortic diameter at the intended distal sealing zone is between 20-36 mm
7. For Dissection with distal sealing, aortic diameter at the intended distal sealing zone is between 22-40 mm
8. LSA branch does not require additional stenting further into the LSA (beyond the Arcevo™ LSA)
9. The intended LSA sealing zone has a diameter between 8.5 mm and 14.0 mm with a length of at least 10 mm
10. Absence of dissection, aneurysm, or stenosis in the intended LSA sealing zone
11. The intended LSA branch position does not interrupt flow to any branch vessel (e.g., left vertebral artery)
12. Patient does not have computed tomography (CT) evidence of extreme arch or LSA angulation precluding safe passage of the Arcevo™ LSA and delivery system
13. LSA take-off angle between 15° and 90°
14. For patients requiring planned extension, there is a ≥ 2 cm distal seal zone for the TEVAR device without a severely angulated descending aorta
15. For patients requiring planned extension, patient has suitable iliac artery anatomy for safe passage of the TEVAR delivery system
1. ≥18 years of age or ≤80 years of age (male or female) at time of surgery
2. 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
3. Patient, or patient's legally authorized representative (LAR; in the secondary arm only), provides written informed consent prior to any study procedures
4. Patient's surgery occurs within 90 days of informed consent
Anatomical Inclusion Criteria
5. Aortic diameter at the intended Arcevo™ LSA anastomosis site is ≥ 21 mm
6. For Aneurysm with distal sealing (i.e., single stage procedure), aortic diameter at the intended distal sealing zone is between 20-36 mm
7. For Dissection with distal sealing, aortic diameter at the intended distal sealing zone is between 22-40 mm
8. LSA branch does not require additional stenting further into the LSA (beyond the Arcevo™ LSA)
9. The intended LSA sealing zone has a diameter between 8.5 mm and 14.0 mm with a length of at least 10 mm
10. Absence of dissection, aneurysm, or stenosis in the intended LSA sealing zone
11. The intended LSA branch position does not interrupt flow to any branch vessel (e.g., left vertebral artery)
12. Patient does not have computed tomography (CT) evidence of extreme arch or LSA angulation precluding safe passage of the Arcevo™ LSA and delivery system
13. LSA take-off angle between 15° and 90°
14. For patients requiring planned extension, there is a ≥ 2 cm distal seal zone for the TEVAR device without a severely angulated descending aorta
15. For patients requiring planned extension, patient has suitable iliac artery anatomy for safe passage of the TEVAR delivery system
Gender
All
Gender Based
false
Keywords
total arch replacement
frozen elephant trunk
aortic arch aneurysm
aortic arch dissection
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
18 Years
NCT Id
NCT07089576
Org Class
Industry
Org Full Name
Artivion Inc.
Org Study Id
ART2401.000-C
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Description
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
* All-cause mortality
* New permanent disabling stroke
* New permanent paraplegia and/or paraparesis
* Unanticipated aortic reoperation in the treated segment
* LSA occlusion
Outcome Measure
Composite Rate of Patients Free From ≥1 Major Adverse Event
Outcome Time Frame
1 year post-index procedure of LSA stent graft implant
Secondary Outcomes
Outcome Description
All-cause, Cardiovascular-related, Aorta-related, Procedure-related, Device-related
Outcome Time Frame
Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Outcome Measure
Rate of Mortality
Outcome Description
All unplanned aortic procedures (endovascular, percutaneous, and open), Unanticipated aortic reoperations in the treated segment, Unanticipated device-related reoperations, Arcevo LSA explant
Outcome Time Frame
Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Outcome Measure
Rate of Patients with ≥1 Additional Aortic Procedure
Outcome Description
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)
Outcome Time Frame
Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Outcome Measure
Rate of Patients with ≥1 Device-Related Event
Outcome Description
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
Outcome Time Frame
Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Outcome Measure
Rate of Patients with Major Adverse Events
Outcome Description
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).
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).
Outcome Time Frame
Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Outcome Measure
Rate of Patients with Radiographic Events (determined by Core Lab)
Outcome Description
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
Outcome Time Frame
Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Outcome Measure
Rate of Patients Requiring a Thoracic Extension Procedure who Experience Device-Extension Failure
Outcome Description
Type IIIa Endoleak
Outcome Time Frame
Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of index procedure
Outcome Measure
Rate of Patient Requiring a Thoracic Extension Procedure with Evidence of Type IIIa Endoleak
Outcome Description
Failed patency of the device-extension overlap
Outcome Time Frame
Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Outcome Measure
Rate of Patients Requiring Thoracic Extension Procedure with Failed Patency
Outcome Description
All-cause mortality, new permanent disabling stroke, new permanent paraplegia and/or paraparesis, unanticipated aortic reoperation in the treated segment, LSA occlusion
Outcome Time Frame
30 days post-extension procedure
Outcome Measure
Rate of Patients Requiring Thoracic Extension Procedure with ≥1 Primary Major Adverse Events
Outcome Description
Secondary procedures related to the extension
Outcome Time Frame
30 days post-extension procedure
Outcome Measure
Rate of Patients Requiring Thoracic Extension Procedure Requiring ≥1 Secondary Procedure Related to Extension
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Joseph Derose
Investigator Email
joseph.derose@einsteinmed.edu
Investigator Department
Cardiothoracic & Vascular Surgery
Investigator Sponsor Organization
Montefiore
Study Department
Cardiovascular and Thoracic Surgery
Study Division
Vascular Surgery
Categories Mesh Debug
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
ANEURYSM, AORTIC ARCH
DISSECTION, THORACIC AORTA
AORTIC ANEURYSM, THORACIC
AORTIC ANEURYSM
ANEURYSM
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
AORTIC DISEASES
AORTIC DISSECTION
DISSECTION, BLOOD VESSEL
ACUTE AORTIC SYNDROME