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

March 19, 2026 updated by: Shape Memory Medical, Inc.
To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital
        • Contact:
        • Sub-Investigator:
          • Andrew Hill, MD
        • Sub-Investigator:
          • Anastasia Dean, MD
        • Principal Investigator:
          • Andrew Holden, MBChB
        • Sub-Investigator:
          • Abdelaziz Marzoug, MBChB
      • Hamilton, New Zealand, 3204
        • Recruiting
        • Waikato Hospital
        • Contact:
        • Principal Investigator:
          • Manar Khashram, MBChB, PhD

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Intervention
Device: False Lumen Embolization System Device: IMPEDE-FX RapidFill
Device: False Lumen Embolization System, IMPEDE-FX RapidFill
Embolization of the false lumen of an aortic dissection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Major adverse events
Time Frame: 30 days
Incidence of device/procedure-related major adverse events
30 days
Technical success
Time Frame: Immediately after the intervention
Delivery and implantation of the investigational product implant to the false lumen
Immediately after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause mortality and dissection-related mortality
Time Frame: 2 years
Incidence of all-cause mortality and dissection-related mortality
2 years
Serious adverse events
Time Frame: 2 years
Incidence of device/procedure-related serious adverse events
2 years
Change in false lumen thrombosis from baseline
Time Frame: 2 years
Change in false lumen thrombosis from baseline
2 years
Change in true lumen/aorta size ratio from baseline
Time Frame: 2 years
Change in true lumen/aorta size ratio from baseline
2 years
Change in aorta size from baseline
Time Frame: 2 years
Change in aorta size from baseline
2 years
Rate of dissection-related reinterventions
Time Frame: 2 years
Rate of dissection-related reinterventions
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shape Memory Medical, Inc.

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRD1043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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