Aortic DissectionFLAGSHIP_CHLNCT07387250
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_CHL)
A study testing False Lumen Embolization System, IMPEDE-FX RapidFill in people with Aortic Dissection, run by Shape Memory Medical, Inc..
Trial summary
To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- False Lumen Embolization System, IMPEDE-FX RapidFill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
About this study
Official title: False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study
To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.
- Conditions
- Aortic Dissection
- Being tested
- False Lumen Embolization System, IMPEDE-FX RapidFill
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
False Lumen Embolization System, IMPEDE-FX RapidFillDevice
Embolization of the false lumen of an aortic dissection
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention | Experimental | Device: False Lumen Embolization System Device: IMPEDE-FX RapidFill Receives: Device: False Lumen Embolization System, IMPEDE-FX RapidFill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Delivery and implantation of the investigational product implant to the false lumen
Measured: Immediately after the intervention
Major adverse events
Incidence of device/procedure-related major adverse events
Measured: 30 days
Secondary outcomes (6)
All-cause mortality and dissection-related mortality
Incidence of all-cause mortality and dissection-related mortality
Measured: 2 years
Serious adverse events
Incidence of device/procedure-related serious adverse events
Measured: 2 years
Change in false lumen thrombosis from baseline
Change in false lumen thrombosis from baseline
Measured: 2 years
Change in true lumen/aorta size ratio from baseline
Change in true lumen/aorta size ratio from baseline
Measured: 2 years
Change in aorta size from baseline
Change in aorta size from baseline
Measured: 2 years
Rate of dissection-related reinterventions
Rate of dissection-related reinterventions
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shape Memory Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387250
- Sponsor's protocol ID
- CRD1063
- Acronym
- FLAGSHIP_CHL
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study
- ClinicalTrials.gov ID
- NCT07387250
- Acronym / sponsor ID
- FLAGSHIP_CHL / CRD1063
- Conditions
- Aortic Dissection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shape Memory Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention | Experimental | Device: False Lumen Embolization System, IMPEDE-FX RapidFillDevice: False Lumen Embolization System Device: IMPEDE-FX RapidFill |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| False Lumen Embolization System, IMPEDE-FX RapidFillEmbolization of the false lumen of an aortic dissection | Device | Experimental: Intervention |
Primary outcome
Technical success
Time frame: Immediately after the intervention
Delivery and implantation of the investigational product implant to the false lumen
Major adverse events
Time frame: 30 days
Incidence of device/procedure-related major adverse events
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing False Lumen Embolization System, IMPEDE-FX RapidFill in people with Aortic Dissection, run by Shape Memory Medical, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: Immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.