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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02323581
Recruitment Status : Recruiting
First Posted : December 23, 2014
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
Darren Schneider, M.D., University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Thoracoabdominal Aortic Aneurysm Aortic Arch Aneurysm Device: Endovascular treatment of Thoracoabdominal Aortic Aneurysm Device: Endovascular treatment of Aortic Arch Aneurysms Not Applicable

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 a standard configuration branched and fenestrated stent graft (TAAA Device) or physician-specified branched and fenestrated stent grafts (Physician-Specified TAAA Devices) 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility, Safety, and Clinical Outcomes of Endovascular Treatment of Thoracoabdominal Aortic Aneurysms and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts
Actual Study Start Date : November 2013
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAAA (thoracoabdominal aortic aneurysm) Study Arm

Either the TAAA device or the Physician-Specified TAAA Device will be implanted.

The TAAA Device is a standard configuration branched stent graft with a combination of two branches for the mesenteric arteries and two fenestrations for the renal arteries.

The Physician-Specified TAAA Devices are designed on a per patient basis and may include a combination of up to 4 fenestrations and branches for mesenteric and renal arteries. An additional 5th branch or fenestration may be included if there is a large accessory renal artery. Branches will be used for downward-oriented mesenteric and renal arteries and fenestrations for renal arteries that project laterally or upwards.

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.


Experimental: Aortic Arch Study Arm
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.
Device: 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.





Primary Outcome Measures :
  1. Technical Success [ Time Frame: 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

  2. Freedom from aneurysm-related mortality at 1 year [ Time Frame: 1 year ]
    Survival from aneurysm-related death.

  3. Procedural Success [ Time Frame: 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 :
  1. Target artery patency [ Time Frame: Yearly through 5 years ]
    Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate target artery patency.

  2. Freedom from all-cause mortality [ Time Frame: 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.

  3. Freedom from reintervention [ Time Frame: 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.

  4. Freedom from endoleak [ Time Frame: Yearly through 5 years ]
    Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.

  5. Freedom from aneurysm dilatation [ Time Frame: Yearly through 5 years ]
    Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate aneurysm size.

  6. Freedom from serious adverse events (SAE) and major complications [ Time Frame: 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.

  7. Freedom from aneurysm rupture and conversion to open repair [ Time Frame: 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.

  8. Freedom from stent graft migration and branch device migration [ Time Frame: Yearly through 5 years ]
    Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 or ruptured 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323581


Contacts
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Contact: Darren Schneider, MD 215-614-0243 Darren.Schneider@Pennmedicine.upenn.edu
Contact: Taylor Hefka, MA 215-615-8036 Taylor.hefka@pennmedicine.upenn.edu

Locations
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United States, New York
New York Presbyterian Hospital Active, not recruiting
New York, New York, United States, 10022
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Darren Schneider, MD    215-614-0243    darren.schneider@pennmedicine.upenn.edu   
Contact: Taylor Hefka, MA    215-615-8036    Taylor.hefka@pennmedicine.upenn.edu   
Principal Investigator: Darren Schneider, MD         
Sponsors and Collaborators
Darren Schneider, M.D.
Investigators
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Principal Investigator: Darren Schneider, MD University of Pennsylvania
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Darren Schneider, M.D., Chief, Vascular Surgery and Endovascular Therapy, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02323581    
Other Study ID Numbers: 843522
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Darren Schneider, M.D., University of Pennsylvania:
Thoracoabdominal
Aneurysm
Endovascular
Stent-Graft
Arch
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases