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Not yet recruiting NCT06740721

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

No phase Interventional Aortic Dissection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: False Lumen Embolization System, IMPEDE-FX RapidFill.
Who it may be relevant to
Registry conditions: Aortic Dissection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Device False Lumen Embolization System, IMPEDE-FX RapidFill
    Embolization of the false lumen of an aortic dissection

Primary outcome measures

  • Technical success [Time frame: Immediately after the intervention]
  • Major adverse events [Time frame: 30 days]
Secondary outcome measures (6)
  • All-cause mortality and dissection-related mortality [Time frame: 2 years]
  • Serious adverse events [Time frame: 2 years]
  • Change in false lumen thrombosis from baseline [Time frame: 2 years]
  • Change in true lumen/aorta size ratio from baseline [Time frame: 2 years]
  • Change in aorta size from baseline [Time frame: 2 years]
  • Rate of dissection-related reinterventions [Time frame: 2 years]

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 >2.5 mg/dL (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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06740721 · CRD1041

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗