False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_CHL)

Shape Memory Medical

Status

Begins enrollment in 1 month

Conditions

Aortic Dissection

Treatments

Device: False Lumen Embolization System, IMPEDE-FX RapidFill

Study type

Interventional

Funder types

Industry

Identifiers

NCT07387250

CRD1063

Details and patient eligibility

About

To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥18 years of age.
A candidate for false lumen (FL) embolization with a type B dissection, and no prior primary entry tear/TL treatment, OR
A candidate for FL embolization with a type B or type A dissection, in whom the primary entry tear/TL was treated in a previous procedure, and is now presenting with a FL requiring treatment.

Exclusion criteria

An inability to provide informed consent.
Enrolled in another clinical study other than a registry.
Hyperacute or acute aortic dissection (<15 days from symptom onset).
Untreated or uncovered primary entry/reentry tear proximal to left subclavian artery (before FL treatment with the investigational product).
Vascular disease, aortic rupture, and/or anatomy and/or dissection membrane condition that precludes the safe access and positioning of an introducer sheath and delivery (and expansion) of the investigational product into the FL.
Prior treatment of the FL.
Planned use of investigational devices to treat the primary entry tear and/or TL.
Absence of/inability to create a reentry tear/fenestration adequately positioned and large enough to allow introducer sheath access into the FL.
Planned use of FL embolic devices other than the investigational product.
Prior abdominal aortic aneurysm (AAA) treatment.
Planned concomitant major surgery (e.g., gastrointestinal surgery).
Diagnosed or suspected congenital degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos syndrome).
Coagulopathy or uncontrolled bleeding disorder.
Serum creatinine level >220 µmol/L (within 90 days prior to the procedure).
Cerebrovascular accident within 90 days prior to the procedure.
Myocardial infarction and/or major heart surgery within 90 days prior to the procedure.
Atrial fibrillation that is not well rate controlled.
Unable or unwilling to comply with study follow-up requirements.
Life expectancy of <2 years postprocedure.
Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.
A condition that inhibits radiographic visualization during the study procedure and planned follow-up imaging.
History of allergy to contrast medium that cannot be managed medically.
Uncontrolled comorbid medical condition, including mental health issues, that, in the opinion of the investigator, would adversely affect participation in the study.
Participant is planning to become pregnant or is currently pregnant or lactating. For participants 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 study.