RECRUITING

AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

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Conditions

Aortic Aneurysm, AbdominalAbdominal Aortic Aneurysm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.

Official Title

AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

Quick Facts

Study Start:2024-04-05
Study Completion:2031-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06029660

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥18 years of age
  2. 2. A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women;
  3. 3. Thrombus burden (percentage of the AAA sac occupied by thrombus) \<50%, based on pre-procedure CTA
  4. 4. Maximum Lumen diameter within the AAA sac of ≥40mm.
  5. 5. The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200.
  1. 1. An inability to provide informed consent.
  2. 2. Enrolled in another clinical study that could interfere with the outcomes being studied in this trial.
  3. 3. Unable or unwilling to comply with study follow-up requirements.
  4. 4. Prisoner or member of other vulnerable population
  5. 1. Concomitant iliac artery ectasia or aneurysm
  6. 2. Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac.
  7. 3. Ruptured, leaking, inflammatory or mycotic (infected) aneurysm.
  8. 4. Connective tissue disorder (e.g., Marfan's syndrome)
  9. 5. Aneurysmal disease of the descending thoracic aorta
  10. 6. Excessive calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties
  11. 1. Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Gore Excluder Conformable AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, Medtronic Endurant II and Endurant IIs Stent Graft, or the Terumo TREO Stent Graft to treat the AAA
  12. 2. Use of an aortic stent graft other than those specified1 for a particular site
  13. 3. Planned use of the chosen stent graft outside its instructions for use (IFU)
  14. 4. Use of fenestrated stent grafts or chimney techniques
  15. 5. Use of the Heli-FX EndoAnchor system
  16. 6. Use of embolic devices other than the investigational product to embolize the AAA sac
  17. 7. Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries
  18. 8. Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries
  19. 1. Coagulopathy or uncontrolled bleeding disorder
  20. 2. Serum creatinine level \>2.5 mg/dL
  21. 3. Cerebrovascular accident within 3 months prior to the procedure
  22. 4. Myocardial infarction and/or major heart surgery within 3 months prior to the procedure
  23. 5. Atrial fibrillation that is not well rate controlled
  24. 6. Life expectancy of \<2 years post-procedure
  25. 7. Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.
  26. 8. Have active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC \>11,000/mm3)
  27. 9. A condition that inhibits radiographic visualization during the implantation procedure
  28. 10. History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CT with contrast for any reason.
  29. 11. Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial
  30. 12. Pregnant or lactating female: for females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the trial

Contacts and Locations

Study Contact

Ann Martin
CONTACT
707.849.2213
amartin@namsa.com
Peter Miller, M.S.
CONTACT
p.miller@shapemem.com

Principal Investigator

Marc Schermerhorn, M.D.
PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center

Study Locations (Sites)

Honor Health
Scottsdale, Arizona, 85258
United States
USC Keck
Los Angeles, California, 90033
United States
Delray Medical Center
Delray Beach, Florida, 33484
United States
Orlando Health
Orlando, Florida, 32806
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Corewell Health
Grand Rapids, Michigan, 49503
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Buffalo VA Western New York
Buffalo, New York, 14215
United States
NYU Langone
New York city, New York, 10016
United States
Columbia University Medical Center
New York, New York, 10032
United States
University of Rochester
Rochester, New York, 14642
United States
TriHealth Heart Institute
Cincinnati, Ohio, 45242
United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Vanderbilt University
Nashville, Tennessee, 37232
United States
Baylor Scott and White
Plano, Texas, 75093
United States
Inova Schar Heart and Vascular
Falls Church, Virginia, 22042
United States
Sentara Norfolk General
Norfolk, Virginia, 23507
United States
University of Wisconsin
Madison, Wisconsin, 53715
United States

Collaborators and Investigators

Sponsor: Shape Memory Medical, Inc.

  • Marc Schermerhorn, M.D., PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-05
Study Completion Date2031-06

Study Record Updates

Study Start Date2024-04-05
Study Completion Date2031-06

Terms related to this study

Keywords Provided by Researchers

  • Abdominal Aortic Aneurysm

Additional Relevant MeSH Terms

  • Aortic Aneurysm, Abdominal