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

Not Applicable

Recruiting

• Conditions: Aortic Aneurysm, Thoracoabdominal; Aortic Aneurysm, Thoracic; Aortic Dissection, Thoracoabdominal
• Interventions: Device: Endovascular treatment of Aortic Arch Aneurysms; Device: Endovascular treatment of Thoracoabdominal Aortic Aneurysm

• Registration Number: NCT02323581
• Lead Sponsor: Darren Schneider, M.D.

Brief 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.

Detailed 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 1) physician-specified aortic arch stent graft device with up to 3 antegrade and/or retrograde branches 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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2028-12
• Study Completion: 2033-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 370

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aortic Arch Study Arm	Endovascular treatment of Aortic Arch Aneurysms	Physician-specified double inner branch stent-graft with or without retrograde left subclavian branch or a physician-specified retrograde left subclavian branch stent-graft with double or triple wide scallop to the left common carotid artery.
TAAA (thoracoabdominal aortic aneurysm) Study Arm	Endovascular treatment of Thoracoabdominal Aortic Aneurysm	Either the Off-the-Shelf TAAA device or the Physician-Specified TAAA Device will be implanted. The Off-the-Shelf TAAA Device is a standard configuration Zenith t-Branch with four branches for the mesenteric arteries and the renal arteries. The Physician-Specified TAAA Devices may include a combination of up to 5 fenestrations and branches for mesenteric and renal arteries. Branches will be used for downward-oriented mesenteric and renal arteries and fenestrations for renal arteries that project laterally or upwards.

Primary Outcome Measures

Name	Time	Method
Technical Success	Intraoperative	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
Freedom from aneurysm-related mortality at 1 year	1 year	Survival from aneurysm-related death.
Treatment success at 12 months post-procedure	1 year	Composite endpoint which includes Technical Success, Procedural Success, and freedom from aneurysm-related mortality
Procedural Success	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Freedom from reintervention	Yearly through 5 years	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.
Freedom from endoleak	Yearly through 5 years	Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.
Freedom from loss of target vessel patency	Yearly through 5 years	Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.
Target artery patency	Yearly through 5 years	Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate target artery patency.
Freedom from all-cause mortality	Yearly through 5 years	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.
Freedom from aneurysm rupture and conversion to open repair	Yearly through 5 years	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.
Freedom from aneurysm dilatation	Yearly through 5 years	Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate aneurysm size.
Freedom from serious adverse events (SAE) and major complications	Yearly through 5 years	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.
Freedom from stent graft migration and branch device migration	Yearly through 5 years	Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.
Freedom from major stroke	Yearly through 5 years	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.
Freedom from paralysis	Yearly through 5 years	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.
Freedom from onset permanent hemodialysis	Yearly through 5 years	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.
Freedom from bowel infarction	Yearly through 5 years	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.
Freedom from amputation	Yearly through 5 years	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.

Trial Locations

Locations (2)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

New York Presbyterian Hospital; 🇺🇸 New York, New York, United States