Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Endovascular Treatment of Thoracic Aortic Disease (EVOLVE Aorta)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00583817
Recruitment Status : Enrolling by invitation
First Posted : December 31, 2007
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Matthew Eagleton, Massachusetts General Hospital

Brief Summary:
The purpose of this study is to assess the role endovascular therapy to treat aortic disease involving the ascending aorta, the aortic arch, and the visceral segment of the aorta (or thoracoabdominal aorta)

Condition or disease Intervention/treatment Phase
Thoracic Aortic Aneurysms Dissecting, Aneurysm Ascending Aorta Aneurysm Aortic Arch; Aneurysm, Dissecting Ascending Aortic Dissection Thoracoabdominal Aortic Aneurysm Renal Artery Aneurysm Superior Mesenteric Artery Aneurysm Aortic Dissection Device: Endovascular stent-graft implantation Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endovascular Treatment of Thoracic Aortic Disease
Actual Study Start Date : October 25, 2018
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ascending Aortic Arm
Investigational endovascular stent-graft implantation to exclude aneurysm or repair dissection of the ascending aorta.
Device: Endovascular stent-graft implantation
Endovascular repair of aorta
Other Names:
  • Arch Branched Device (Cook Medical)
  • Custom Made Fenestrated/Branched Endovascular Device (Cook Medica)
  • Helical Hypogastric Branched Device (Cook Medical)
  • Ascending Aortic Endograft (Cook Medical)

Experimental: Arch Branch Arm
Investigational endovascular stent-graft implantation to exclude aneurysm or repair dissection of the aortic arch.
Device: Endovascular stent-graft implantation
Endovascular repair of aorta
Other Names:
  • Arch Branched Device (Cook Medical)
  • Custom Made Fenestrated/Branched Endovascular Device (Cook Medica)
  • Helical Hypogastric Branched Device (Cook Medical)
  • Ascending Aortic Endograft (Cook Medical)

Experimental: Thoracoabdominal Aortic Arm
Investigational endovascular stent-graft implantation to exclude thoracoabdominal aortic pathology including aortic aneurysms, renal artery aneurysms, and superior mesenteric artery aneurysms.
Device: Endovascular stent-graft implantation
Endovascular repair of aorta
Other Names:
  • Arch Branched Device (Cook Medical)
  • Custom Made Fenestrated/Branched Endovascular Device (Cook Medica)
  • Helical Hypogastric Branched Device (Cook Medical)
  • Ascending Aortic Endograft (Cook Medical)




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 5 years ]
    Freedom from death in perioperative and follow up time period

  2. Stroke and TIA [ Time Frame: 30 days ]
    Freedom from peri-operative neurologic event

  3. Aneurysm-related death [ Time Frame: 5 years ]
    Freedom from aneurysm death related to reintervention or incomplete repair



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.


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

Ascending Arm Protocol:

  1. General Inclusion Criteria (Must meet ALL of the following):

    • Life expectancy greater than 2 years
    • Suitable arterial anatomy
    • Absence of systemic disease or allergy that precludes an endovascular repair
    • Capable of giving informed consent and willingness to comply with follow up schedule
    • Patient is considered high or prohibitive risk for open surgical repair of the ascending aneurysm or dissection
  2. Anatomic Inclusion Criteria

    • Have ONE of the following

      1. Focal aneurysm in ascending aorta
      2. Pseudoaneurysms and/or dissections that are distal to the sinotubular junction.
      3. The aneurysm should be >5.0 cm in diameter
      4. Have morphology or growth suggestive of immanent rupture
    • Must meet ALL of the following:

      1. Proximal Fixation:

        1. >15 mm aortic length distal to a patent coronary artery or coronary artery bypass that are considered patent and necessary for proper cardiac perfusion.

          • Proximal fixation may occur in either native aorta or surgical graft
          • In the setting of the aortic dissection, the proximal fixation must be proximal to the entry tear.
          • In the setting of aortic dissection, true lumen size must be large enough to allow deployment of the device
        2. Aortic diameter at the sinotubular junction >20 mm and ≤ 38mm
      2. Distal Fixation: a length of distal ascending aorta >5mm proximal to the innominate artery whereby seal and fixation can be achieved (the dissection flap may transcend the arch, but the seal must be achievable within the true lumen of the dissection)

        1. Aortic diameter (true lumen diameter in the setting of a dissection) at the innominate artery is ≤ 42mm. If the diameter at the innominate artery is ≥ 38mm the Low Profile version must be used
        2. Distance from the ascending aorta to the innominate artery must be >35mm
    • Iliac artery access

      1. Iliac anatomy must allow for the delivery of the endograft device which is loaded within an 18F-24F sheath.
      2. Conduits to the iliac vessels or aorta may be used if deemed necessary
      3. In the setting of an aortic dissection, access into the true lumen throughout the length of the aorta must be obtainable

Arch Arm Protocol

  1. General Inclusion Criteria (Must meet ALL of the following):

    • Life expectancy greater than 2 years
    • Suitable arterial anatomy
    • Absence of systemic disease or allergy that precludes an endovascular repair
    • Capable of giving informed consent and willingness to comply with follow up schedule
    • Patient is considered high or prohibitive risk for open surgical repair of the ascending aneurysm or dissection
  2. Anatomic Inclusion Criteria

    • Must meet ALL of the following:

      1. Aneurysm of the ascending aorta or aortic arch/proximal descending thoracic aorta that is >5.5cm or is considered to be at high risk for rupture or dissection given the morphologic characteristics of the aneurysm (or diverticulum).
      2. Proximal aortic fixation zone:

        1. Native aorta or surgical graft (If surgical graft in ascending aorta, the angulation within the graft must be <90 degrees)
        2. Diameter: 20-42mm
        3. Proximal neck length ≥10mm
        4. Ascending aortic length >50mm
        5. Must occur distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion
      3. Distal aortic fixation zone:

        1. Native aorta or surgical graft
        2. Diameter: 20-42mm
        3. Distal neck length ≥10mm
      4. Supra-aortic trunk (brachiocephalic) vessels

        1. Although the prosthesis will typically have two branches, modifications to the design will allow for a single branch or three branches. Thus, it is generally planned that at least one extra-anatomic bypass graft will be done in conjunction (or in a staged fashion) with the procedure. The two vessels incorporated into the endograft repair would most commonly be the innominate artery and left carotid artery. However, the innominate artery may be coupled with the left subclavian artery in the setting of a bovine arch whereby the flow to the left carotid would come from a left subclavian to carotid bypass. Similarly, the left carotid and subclavian artery may be branched, or simply one vessel branched should specific anatomic limitations exist. In such a situation, multiple extra-anatomic bypasses may be necessary. Thus the inclusion criteria are defined for each artery, yet any combination of arteries may be used for a repair.
        2. Diameter of vessel(s) to be incorporated into endograft

          • Innominate artery: 8-22 mm.
          • Left (or right) common carotid artery: 6-16mm
          • Left (or right) subclavian artery: 5-20mm
          • Length of sealing zone ≥ 10mm
          • Acceptable tortuosity
      5. In the setting of an aortic dissection the following criteria must exist:

        1. Access into the true lumen from the groin and at least one supra-aortic trunk vessel
        2. A sealing zone in the target aorta (or surgical graft) that is proximal to the primary dissection, such that a stent graft would be anticipated to seal off the dissection lumen
        3. A sealing zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen, or surgically created
        4. A true lumen size large enough to deploy the device and still gain access into the target branches
      6. In the setting of a more distal disease, the repair may be coupled with a thoracoabdominal branched device, infrarenal device, and/or internal iliac branch device - typically performed in a staged fashion
      7. Iliac anatomy must allow for the delivery of the arch branch device which is loaded within an 18F-24F sheath. Conduits to the iliac vessels or aorta may be used if deemed necessary.

Thoracoabdominal Arm Protocol

  1. General Inclusion Criteria (Must meet ALL of the following):

    • Life expectancy greater than 2 years
    • Suitable arterial anatomy
    • Absence of systemic disease or allergy that precludes an endovascular repair
    • Capable of giving informed consent and willingness to comply with follow up schedule
  2. Anatomic Inclusion Criteria

    • Presence of at least one of the following aneurysms is necessary to drive the need for a repair with a fenestrated/branched device:

      1. A thoracoabdominal aortic aneurysm ≥ 4 cm or suggestive of a high risk of rupture as a result of morphology, growth history or symptoms
      2. A renal artery aneurysm > 20 mm (or twice the diameter of native renal artery)
      3. An SMA aneurysm >30 mm
    • Outside of the "Indications for Use" for commercially available fenestrated or branched endografts approved for use for the treatment of these aneurysms.
    • Proximal neck

      1. Diameter ≤ 40 mm, ≥20 mm
      2. Proximal neck length ≥ 10mm.
      3. The proximal landing zone may be in a prior endograft or a prior surgical graft.
    • Iliac Artery

      1. Diameter ≥ 7 mm (anticipated diameter following balloon angioplasty, stenting, dottoring, or conduit) or ≥ 6 mm for patients receiving an Low-Profile device.
      2. Iliac angulation that will not preclude device delivery or surgical modification of the iliac system
      3. For a bifurcated or aorto-monoiliac prosthesis, iliac implantation sites require ≤ 20 mm in diameter and ≥ 20 mm in length
    • For a straight aorto-aortic prosthesis, distal neck (normal aorta between the aneurysm and iliac bifurcation) ≥ 10 mm in length and ≤ 40 mm in diameter
    • If a hypogastric branch will be used to treat the common iliac aneurysm

      1. The intended common iliac artery is > 20mm in diameter or the aneurysm has morphology concerning for rupture; and
      2. The intended distal fixation site within the internal iliac is ≤ 10mm in diameter.
    • Renal arteries or other visceral vessels arising from the aorta in an orientation that is evident and measurable from cross-sectional imaging (CT or MR)
    • Visceral branch diameters (for incorporated vessels) between 4 mm - 11 mm at the intended distal sealing site (thus distal to a visceral artery aneurysm in such circumstances).
    • Greater than 5 mm of proximal visceral branch length to allow for a seal with the mated device, or the ability to exclude an early branch.
    • In the setting of an aortic dissection the following criteria must exist:

      1. Access into the true lumen from the groin and at least one supra-aortic trunk vessel
      2. A sealing zone in the target aorta (or surgical graft) that is proximal to the primary dissection, such that a stentgraft would be anticipated to seal off the dissection lumen
      3. A sealing zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen, or surgically created
      4. A true lumen size large enough to deploy the device and still gain access into the target branches
    • In the setting of a more proximal disease, the repair may be coupled with an arch-branched device, thoracic aortic endograft, or surgical aortic repair - typically performed in a staged fashion

General Exclusion Criteria

  1. Patient can be treated in accordance with the instructions for use with a commercially marketed endovascular prosthesis
  2. Pregnancy
  3. History of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately
  4. Known sensitivity or allergy to materials of construction of the device (including the materials of the LP device).
  5. Body habitus that would inhibit X-ray visualization of the aorta
  6. Subject had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned <30 days from the endovascular repair
  7. Unstable angina
  8. Unwilling to comply with follow up schedule
  9. Systemic or local infection that may increase the risk of endovascular graft infection
  10. An uncorrectable coagulopathy

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): NCT00583817


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Matthew Eagleton
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Matthew J Eagleton, MD Massachusetts General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Matthew Eagleton, Staff, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00583817    
Other Study ID Numbers: G000101
2018P001301 ( Other Identifier: Massachusetts General Hospital IRB )
2018P001300 ( Other Identifier: Massachusetts General Hospital IRB )
2018P001299 ( Other Identifier: Massachusetts General Hospital IRB )
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm, Dissecting
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Aortic Diseases
Vascular Diseases
Cardiovascular Diseases