Skip to main content
(352) 733-0111

ARISE III

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
Share this study
Facebook
Twitter
LinkedIn

Objective

To assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.

Description

This pivotal investigation is a prospective, multicenter, non-randomized, single-arm study to evaluate the safety and effectiveness of the ASG device for the treatment of de novo Type A aortic dissections in patients considered to be high-risk for open surgical repair.

Details

Full study title Evaluation of the GORE? Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Protocol number OCR48271
ClinicalTrials.gov ID NCT06827990
Phase N/A

Eligibility

Inclusion Criteria * Primary Arm:

The subject is/has:

  1. De novo Type A aortic dissection (≤30 days from symptom onset to index endovascular procedure) compatible with the treatment requirements of the ASG device.

  2. Primarily intended to be treated by placement of the ASG device in the ascending aorta. Distal adjunctive procedures not in contact with the ASG device may be performed during the index endovascular procedure at the discretion of the Investigator.

  3. Anatomic compatibility of the ascending aorta required for implanting the ASG

Device:

a) Proximal Aortic Landing Zone: i. Primary entry tear must be in the ascending

aorta and ≥ 2 cm distal to the most distal coronary artery ostium.

ii. Total aortic diameter between 27mm * 48mm iii. Landing zone cannot be heavily calcified or thrombosed. b) Distal Aortic Landing Zone: i. Primary entry tear must be in the ascending aorta and ≥ 2 cm proximal to BCA ostium. c) Adequate aortic length

  1. The Aortic Treatment Team (as defined by the protocol) attest endovascular repair is in the best interest of the patient AND considers the patient to be high-risk for

Open surgical repair by meeting at least one of the following criteria:

  1. ≥80 years of age

  2. Body mass index (BMI) ≥ 35 kg/m2

  3. History of Respiratory Insufficiency (defined by home O2 usage, exertional dyspnea, imaging evidence of COPD, previous evidence of compromised pulmonary function tests (PFT) on spirometry or other factors as determined by the Investigator)

  4. Prior Cardiac Surgery

  5. Hostile Chest (VARC-2 Definition)

  6. Clinical Frailty Scale 3-7

  7. Clinical malperfusion (head, gut, lower extremity)

  8. Transfusion is not possible (e.g., Jehovah's Witness)

  9. Renal Dialysis prior to aortic dissection

  10. Chronic renal insufficiency (eGFR

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.