Shape‑memory polymer to seal the false lumen and prevent aortic enlargement

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

This trial will try a shape‑memory polymer implant to seal the false lumen and stop aortic growth in adults with type B dissection or treated type A dissection who need false lumen repair.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shape Memory Medical, Inc. (Industry-sponsored)
• Locations: 2 sites (Auckland and 1 other locations)
• Trial ID: NCT06550986 on ClinicalTrials.gov

What this trial studies

This first‑in‑human interventional trial tests a False Lumen Embolization System (IMPEDE‑FX RapidFill) made from a shape‑memory polymer, delivered endovascularly into the false lumen to reduce blood flow. Participants include adults with type B dissection without prior primary entry treatment or patients with a previously treated primary entry who now have a persistent false lumen requiring treatment. The procedure places and expands the polymer device in the false lumen to promote occlusion while the study tracks procedural feasibility, device behavior, safety events, and imaging changes in false lumen perfusion and aortic size over follow‑up. Patients with unsuitable anatomy, untreated proximal tears, recent acute dissections, or prior false lumen treatment are excluded to reduce procedural risk.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with a type B dissection or a previously treated primary entry who now have a persistent false lumen amenable to endovascular embolization and with vascular anatomy suitable for device delivery.

Not a fit: Patients in the hyperacute/acute phase (<15 days), those with untreated proximal tears, prior false lumen treatment, unsuitable vascular anatomy, or who cannot provide informed consent are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the device could reduce false lumen perfusion, slow or stop aortic enlargement, and lower the need for further open or endovascular surgeries.

How similar studies have performed: This is a first‑in‑human application of this shape‑memory polymer for aortic false lumen occlusion; while other embolic materials have been used in peripheral and neurovascular settings, evidence for false lumen aortic occlusion is limited.

Eligibility criteria

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.

Where this trial is running

Auckland and 1 other locations

• Auckland City Hospital — Auckland, New Zealand (Recruiting)
• Waikato Hospital — Hamilton, New Zealand (Recruiting)

Study contacts

• Study coordinator: Peter Miller, M.S.

Conditions Aortic Dissection