Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts

Aortic Aneurysm, Thoracic Clinical Trial

Official title:

Feasibility, Safety, and Clinical Outcomes of Endovascular Treatment of Thoracoabdominal Aortic Aneurysms and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02323581
• Other study ID #: 843522
• Status: Recruiting
• Phase: N/A
• Start date: November 2013
• Est. completion date: December 2033

Study information

• Verified date: October 2023
• Source: University of Pennsylvania
• Contact: Darren Schneider, MD
• Phone: 215-614-0243
• Email: Darren.Schneider[@]Pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, nonrandomized, single-center, two-arm study to assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery.

Description:

To assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery in two study arms:

1. TAAA (thoracoabdominal aortic aneurysm) Study Arm: To assess the feasibility and safety and to evaluate clinical outcomes of endovascular stent graft implantation using either a multibranched stent graft (Off-the-Shelf TAAA Device) or custom-manufactured physician-specified branched and/or fenestrated stent graft (Physician-Specified TAAA Device) to treat aortic aneurysms involving the mesenteric and/or renal arteries (TAAA) in patients at high risk for open surgery.

2. Aortic Arch Study Arm: To assess the feasibility and safety and to evaluate clinical outcomes of endovascular stent graft implantation using a physician-specified aortic arch stent graft device [1) double inner branch stent-graft with or without retrograde left subclavian branch or 2) a physician-specified retrograde left subclavian branch stent-graft with double or triple wide scallop to the left common carotid artery] to treat aortic aneurysms involving the aortic arch in patients at high risk for open surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: December 2033
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

TAAA STUDY ARM

Inclusion Criteria:

1. Presence of TAAA in:

1. Men with TAAA greater than or equal to 6 cm in diameter

2. Women with TAAA greater than or equal to 5 cm in diameter

3. Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year

4. Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or

5. Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter

2. Life expectancy more than 2 years

3. Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol

4. Suitable arterial anatomy for endovascular TAAA repair with "TAAA device":

1. Proximal aortic landing zone:

• = 20mm long

• = 40mm and = 20mm diameter in parallel aorta

• free from circumferential thrombus

• = 60 degrees angulation

2. Mesenteric/renal aortic diameter = 20mm

3. Mesenteric arteries:

• = 10mm long segment of healthy artery for branch attachment

• Diameter = 4mm and = 12mm

• Absence of aberrant or early branching, aneurysm or dissection

4. Renal arteries:

• = 10mm long segment of healthy artery for branch attachment

• Diameter = 4mm and = 8mm

• Absence of aberrant or early branching, aneurysm or dissection

5. Iliac artery access:

• = 6mm diameter, and absence of severe calcification and tortuosity

• Or, planned creation of surgical conduit for TAAA device delivery

6. For patients with associated common iliac artery aneurysms (>20mm diameter), adequate internal and external iliac artery landing zones and common iliac artery luminal diameter (for iliac branch device use):

• = 10mm long segment of healthy internal iliac artery for branch attachment

• Internal iliac diameter = 5mm and = 12mm

• External iliac diameter = 6mm diameter, and absence of severe calcification and tortuosity

• Minimum common iliac artery luminal diameter = 14mm

• Or, in patients with bilateral common iliac artery aneurysms without suitable anatomy, planned surgical bypass to maintain patency of at least one internal iliac artery

5. Patients deemed high risk for open repair (meeting one, or more, of the following criteria):

1. Age = 65 year

2. Cardiac disease:

• CAD (history of MI or angina with positive stress test and not revascularizable)

• LV Ejection fraction < 40%

• Symptomatic CHF (NYHC Class II, III, or IV)

3. Pulmonary disease:

• Home oxygen therapy

• FEV1 < 1.2 l/s

• Vital capacity < 50% predicted

• PaCO2 > 45 mm Hg or < 60 mm Hg

4. Renal disease:

• ESRD on dialysis

• eGFR < 60

5. Prior aortic surgery

6. Hostile abdomen

7. Portal hypertension (ascites or varices)

8. Coagulopathy

AORTIC ARCH STUDY ARM

Inclusion Criteria:

1. Presence of aortic arch aneurysm in:

1. Men with aortic arch aneurysm greater than or equal to 6 cm in diameter, or

2. Women with aortic arch aneurysm greater than or equal to 5 cm in diameter, or

3. Men with aortic arch aneurysm larger than 5 cm in diameter and enlarging at a rate of more than 10 mm/year, or

4. Women with aortic arch aneurysm larger than 4.5 cm in diameter and enlarging at a rate of more than 10 mm/year, or

5. Saccular aortic arch aneurysms deemed at significant risk for rupture based upon physician interpretation

2. Life expectancy more than 2 years

3. Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol.

4. Suitable arterial anatomy for endovascular aortic arch repair with "Aortic Arch Device":

1. Aneurysm of the aortic arch beginning distal to the native coronary arteries or any patent coronary artery bypass

2. Proximal aortic landing zone:

• Native aorta or surgical graft

• = 20 mm long

• = 42 mm and = 20 mm diameter in parallel aorta

• free from circumferential thrombus

3. Distal aortic landing zone:

• Native aorta or surgical graft

• = 20 mm long

• = 42 mm and = 20 mm diameter in parallel aorta

• free from circumferential thrombus

• = 50mm length from native coronary arteries or patent coronary bypass graft to innominate artery

4. Adequate supra-aortic trunk branch landing zone(s):

• Innominate artery (if applicable):

• Native vessel or surgical graft

• Diameter: 8-22mm

• Length of sealing zone =10mm

• Acceptable tortuosity

• Absence of dissection in landing zone

• Left (or right) common carotid artery (if applicable):

• Native vessel or surgical graft

• Diameter 6-16mm

• Length of sealing zone =10mm

• Acceptable tortuosity

• Absence of dissection in landing zone

• Left (or right) subclavian artery (if applicable):

• Native vessel or surgical graft

• Diameter: 5-20mm

• Length of sealing zone =10mm

• Acceptable tortuosity

• Absence of dissection in landing zone

5. Iliac artery access:

• = 6mm diameter, and absence of severe calcification and tortuosity

• Or, planned creation of surgical conduit for TAAA device delivery

5. Patients deemed high risk for open surgical aortic arch repair based upon consensus of both a qualified cardiac surgeon and a qualified vascular surgeon and meeting one, or more, of the following criteria):

1. Age > 70 years-old

2. Prior ascending or aortic arch repair

3. Multiple (=2) median sternotomies

4. Ischemic cardiomyopathy with multi-level coronary artery disease and/or positive stress test

5. Chronic pulmonary disease with FEV1 < 1500ml

6. Chronic kidney disease with eGFR = 60 ml/kg/hr

7. Large aneurysm abutting the sternotomy

8. Severe deconditioning or immobility

9. Prior cervical irradiation

10. Other medical condition associated with prohibitive high risk with open repair based upon multidisciplinary consensus (cardiac surgery and vascular surgery)

APPLIES TO BOTH STUDY ARMS

Exclusion Criteria:

1. Rupture, with hypotension (systolic bp < 90).

2. Pregnancy or breastfeeding.

3. Unwillingness or inability to comply with the follow up schedule.

4. Serious systemic or groin infection.

5. Uncorrectable coagulopathy.

6. Age < 18 years.

7. Mycotic aneurysm.

8. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome (unless proximal implantation is into a previously placed surgical graft).

9. Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold.

10. Participation in another in another investigational device or drug study within 1 year of treatment.

11. Unrelated concomitant major surgical or interventional procedure(s) within 30 days of treatment date (with the exception of staged procedures planned as part of treatment)

12. Body habitus that would inhibit X-ray visualization of the aorta.

13. Acute aortic dissection

14. Patients able and willing to be treated with a commercially available device or a device being evaluated in a manufacturer-sponsored pivotal study

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Aneurysm, Thoracoabdominal
• Aortic Dissection

Intervention

Device:
• Endovascular treatment of Thoracoabdominal Aortic Aneurysm
A TAAA is an abnormal enlargement (ballooning out) of the main artery (the aorta) and involves all or part of the aorta in your chest as well as all or part of the aorta in the abdomen. It also involves the part of the aorta where the arteries that bring blood to the liver, stomach and intestines and kidneys are attached. This investigational procedure that is being studied uses stent-grafts (cylindrical fabric tubes (grafts), with metal springs (stents) attached). The stent-grafts are placed inside the aneurysmal (weakened) area of the aorta to re-line it. These customized stent-grafts have special branches attached to them or openings (called "fenestrations") that are used to keep blood flowing to the arteries that supply the liver, stomach, intestines and kidneys. The investigational stent graft will be designed and custom-made specifically for your aneurysm.
• Endovascular treatment of Aortic Arch Aneurysms
An aortic arch aneurysm is an abnormal enlargement (ballooning out) of the main artery (the aorta). The ascending aorta and aortic arch is the first part of the vessel as it exits the heart and makes a turn around the area of the collar bone. This part of the aorta gives branches that supply the head, brain and arms. The arch branch endovascular graft includes the main aortic arch portion and one to three cuffs (side branches) that allow the graft to be located in the aortic arch. The number of cuffs is decided based on the anatomy of your aneurysm. The arteries in the aortic arch are the innominate artery (Zone 0), left common carotid artery (Zone 1) and the left subclavian artery (Zone 2). These arteries supply the right arm and right side of the brain, the left side of the brain and the left arm, respectively.

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Darren Schneider, M.D.

Country where clinical trial is conducted

United States, 

References & Publications (20)

Abdelhalim MA, Tenorio ER, Oderich GS, Haulon S, Warren G, Adam D, Claridge M, Butt T, Abisi S, Dias NV, Kolbel T, Gallitto E, Gargiulo M, Gkoutzios P, Panuccio G, Kuzniar M, Mani K, Mees BM, Schurink GW, Sonesson B, Spath P, Wanhainen A, Schanzer A, Beck — View Citation

Agrusa CJ, Connolly PH, Ellozy SH, Schneider DB. Safety and Effectiveness of Percutaneous Axillary Artery Access for Complex Aortic Interventions. Ann Vasc Surg. 2019 Nov;61:326-333. doi: 10.1016/j.avsg.2019.05.046. Epub 2019 Aug 5. — View Citation

Aucoin VJ, Eagleton MJ, Farber MA, Oderich GS, Schanzer A, Timaran CH, Schneider DB, Sweet MP, Beck AW. Spinal cord protection practices used during endovascular repair of complex aortic aneurysms by the U.S. Aortic Research Consortium. J Vasc Surg. 2021 — View Citation

Aucoin VJ, Motyl CM, Novak Z, Eagleton MJ, Farber MA, Gasper W, Oderich GS, Mendes B, Schanzer A, Tenorio E, Timaran CH, Schneider DB, Sweet MP, Zettervall SL, Beck AW; U.S. Aortic Research Consortium. Predictors and outcomes of spinal cord injury followi — View Citation

Banga P, Oderich GS, Farber M, Reis de Souza L, Tenorio ER, Timaran C, Schneider DB, Baumgardt Barbosa Lima G, Barreira Marcondes G, Timaran D. Impact of Number of Vessels Targeted on Outcomes of Fenestrated-Branched Endovascular Repair for Complex Abdomi — View Citation

Chamseddin K, Timaran CH, Oderich GS, Tenorio ER, Farber MA, Parodi FE, Schneider DB, Schanzer A, Beck AW, Sweet MP, Zettervall SL, Mendes B, Eagleton MJ, Gasper WJ; U.S. Aortic Research Consortium. Comparison of upper extremity and transfemoral access fo — View Citation

Dias-Neto M, Tenorio ER, Huang Y, Jakimowicz T, Mendes BC, Kolbel T, Sobocinski J, Bertoglio L, Mees B, Gargiulo M, Dias N, Schanzer A, Gasper W, Beck AW, Farber MA, Mani K, Timaran C, Schneider DB, Pedro LM, Tsilimparis N, Haulon S, Sweet M, Ferreira E, — View Citation

Dias-Neto M, Vacirca A, Huang Y, Baghbani-Oskouei A, Jakimowicz T, Mendes BC, Kolbel T, Sobocinski J, Bertoglio L, Mees B, Gargiulo M, Dias N, Schanzer A, Gasper W, Beck AW, Farber MA, Mani K, Timaran C, Schneider DB, Pedro LM, Tsilimparis N, Haulon S, Sw — View Citation

Edman NI, Schanzer A, Crawford A, Oderich GS, Farber MA, Schneider DB, Timaran CH, Beck AW, Eagleton M, Sweet MP; U.S. Fenestrated and Branched Aortic Research Consortium. Sex-related outcomes after fenestrated-branched endovascular aneurysm repair for th — View Citation

Finnesgard EJ, Beck AW, Eagleton MJ, Farber MA, Gasper WJ, Lee WA, Oderich GS, Schneider DB, Sweet MP, Timaran CH, Simons JP, Schanzer A; United States Aortic Research Consortium. Severity of acute kidney injury is associated with decreased survival after — View Citation

Heslin RT, Blakeslee-Carter J, Novak Z, Eagleton MJ, Farber MA, Oderich GS, Schanzer A, Timaran CH, Schneider DB, Sweet MP, Beck AW. Aneurysm extent-based mortality differences in complex endovascular repair of thoracoabdominal aneurysms in the Vascular Q — View Citation

Kitpanit N, Ellozy SH, Connolly PH, Agrusa CJ, Lichtman AD, Schneider DB. Risk factors for spinal cord injury and complications of cerebrospinal fluid drainage in patients undergoing fenestrated and branched endovascular aneurysm repair. J Vasc Surg. 2021 — View Citation

Meltzer AJ, Connolly PH, Ellozy S, Schneider DB. Patient-reported Quality of Life after Endovascular Repair of Thoracoabdominal Aortic Aneurysms. Ann Vasc Surg. 2017 Oct;44:164-170. doi: 10.1016/j.avsg.2017.04.009. Epub 2017 May 17. — View Citation

Schneider DB, Agrusa CJ, Ellozy SH, Connolly PH, Meltzer AJ, Graham AR, Michelassi F. Analysis of the Learning Curve and Patient Outcomes of Endovascular Repair of Thoracoabdominal Aortic Aneurysms Using Fenestrated and Branched Stent Grafts: Prospective, — View Citation

Stern JR, Ellozy SH, Connolly PH, Meltzer AJ, Schneider DB. Utility and safety of axillary conduits during endovascular repair of thoracoabdominal aneurysms. J Vasc Surg. 2017 Sep;66(3):705-710. doi: 10.1016/j.jvs.2016.12.107. Epub 2017 Mar 1. — View Citation

Tenorio ER, Oderich GS, Farber MA, Schneider DB, Timaran CH, Schanzer A, Beck AW, Motta F, Sweet MP; U.S. Fenestrated and Branched Aortic Research Consortium Investigators. Outcomes of endovascular repair of chronic postdissection compared with degenerati — View Citation

Tenorio ER, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Parodi FE, Gasper WJ, Beck AW, Sweet MP, Huang Y, Oderich GS; U.S. Fenestrated and Branched Aortic Research Consortium. Mid-term Renal and Mesenteric Artery Outcomes Duri — View Citation

Tenorio ER, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Parodi FE, Gasper WJ, Beck AW, Sweet MP, Zettervall SL, Huang Y, Oderich GS; U.S. Fenestrated and Branched Aortic Research Consortium. Effect of bridging stent graft sele — View Citation

Timaran CH, Oderich GS, Tenorio ER, Farber MA, Schneider DB, Schanzer A, Beck AW, Sweet MP; Aortic Research Consortium. Expanded Use of Preloaded Branched and Fenestrated Endografts for Endovascular Repair of Complex Aortic Aneurysms. Eur J Vasc Endovasc — View Citation

Zettervall SL, Tenorio ER, Schanzer A, Oderich GS, Timaran CH, Schneider DB, Eagleton M, Farber MA, Gasper WJ, Beck AW, Sweet MP; U.S. Fenestrated and Branched Aortic Research Consortium. Secondary interventions after fenestrated/branched aneurysm repairs — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Success	Successful deployment of the TAAA device or Physician-Specified TAAA Devices, or Aortic Arch device & bridging covered stents into all targeted mesenteric & renal, or supra-aortic arteries with stent-graft & all branches patent by intraop angiography	Intraoperative
Primary	Procedural Success	Technical success plus freedom from type I or III endoleak, loss of target vessel patency, death, major stroke, paralysis, new onset permanent hemodialysis, major amputation, & bowel infarction following deployment of the branched stent-graft.	30 days
Primary	Freedom from aneurysm-related mortality at 1 year	Survival from aneurysm-related death.	1 year
Primary	Treatment success at 12 months post-procedure	Composite endpoint which includes Technical Success, Procedural Success, and freedom from aneurysm-related mortality	1 year
Secondary	Target artery patency	Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate target artery patency.	Yearly through 5 years
Secondary	Freedom from all-cause mortality	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.	Yearly through 5 years
Secondary	Freedom from reintervention	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation to determine if reintervention with the device is necessary.	Yearly through 5 years
Secondary	Freedom from endoleak	Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.	Yearly through 5 years
Secondary	Freedom from aneurysm dilatation	Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate aneurysm size.	Yearly through 5 years
Secondary	Freedom from serious adverse events (SAE) and major complications	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.	Yearly through 5 years
Secondary	Freedom from aneurysm rupture and conversion to open repair	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation to determine if aneurysm stability.	Yearly through 5 years
Secondary	Freedom from stent graft migration and branch device migration	Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.	Yearly through 5 years
Secondary	Freedom from major stroke	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.	Yearly through 5 years
Secondary	Freedom from paralysis	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.	Yearly through 5 years
Secondary	Freedom from onset permanent hemodialysis	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.	Yearly through 5 years
Secondary	Freedom from amputation	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.	Yearly through 5 years
Secondary	Freedom from bowel infarction	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.	Yearly through 5 years
Secondary	Freedom from loss of target vessel patency	Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.	Yearly through 5 years