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Prevention study for Aortic Dissection
Official title False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study
ClinicalTrials.gov ID: NCT06550986
What this study is testing
- What it's testing
- To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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...
You likely can't join if
- 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...
- Prior treatment of the FL.
See the full eligibility 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Auckland, New Zealand
- Hamilton, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Auckland, New Zealand; Hamilton, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.