Aortic DissectionNCT02380716

ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection

A study testing GORE® Ascending Stent Graft in people with Aortic Dissection, run by W.L.Gore & Associates at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft 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?: GORE® Ascending Stent Graft
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Aug 2015to Apr 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

DeBakey Type I/II aortic dissection compatible with the treatment requirements of GORE® Ascending Stent Graft, including:
Primary entry tear must be in the ascending aorta and ≥2cm distal to the most distal coronary artery ostia
Ascending aorta compatible with the GORE® Ascending Stent Graft including landing zone true lumen diameter between 24mm - 42mm and total aortic landing zone diameter ≤ 45 mm
Able to undergo CT scan per protocol requirements to perform required case planning prior to endovascular procedure
High surgical risk, as determined by the implanting physician
Adequate vascular access via transfemoral or retroperitoneal approach
An Informed Consent Form signed by Subject or legally authorized representative
Able to comply with protocol requirements including follow-up

Who cannot join

Planned aortic valve repair or replacement or coronary artery intervention within 30 days
Presence of mechanical heart valve in the aortic position
Primary entry tear location in the aortic arch or descending thoracic aorta with retrograde flow into the ascending aorta
Aortic insufficiency grade 3+ or 4+
Known irreversible neurological injury
Known degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome

Show all 16Show fewer

Participation in another drug or medical device study within 1 year of study enrollment
Known history of drug abuse
Pregnant female at time of informed consent signature
Body habitus or other medical condition which prevents adequate visualization of the aorta
Systemic infection that could increase the risk of endovascular graft infection
Previous thoracic aortic surgery
Life expectancy <12 months due to associated non-cardiac co-morbid conditions
Subject has known sensitivities or allergies to the device materials
Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Southern California- Keck Medicine
Los Angeles, California, 90033

Other trials in United States

About this study

Assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft

Read the detailed description

This study is a prospective, multicenter, non-randomized single-arm study to assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft.

Conditions: Aortic Dissection
Being tested: GORE® Ascending Stent Graft
Keywords: type A dissection
Medical subject headings: Aortic Dissection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GORE® Ascending Stent GraftDevice

Study groups in NCT02380716
Study group	Role	What they receive
GORE® Ascending Stent Graft	Experimental	Treatment with the GORE® Ascending Stent Graft Receives: Device: GORE® Ascending Stent Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

All Cause Mortality at 30 Days Post-procedure
Number of subjects that die of any cause within 30 days post-procedure
Measured: 30 days post-procedure

Secondary outcomes (6)

Successful Dissection Treatment (Technical Success)
Number of subjects with technical success defined as successful access to the aorta, successful deployment of the study device components, successful retrieval of the device delivery system, exclusion of the primary entry tear of the aortic dissection, and patency of the side branch device component, if used.
Measured: At removal of device deployment system, up to conclusion of procedure
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) Assessed Through 30 Days, 6 Months, and 12 Months
Assessed by reported adverse events that meet the MACCE criteria and adjudicated by a Clinical Events Committee
Measured: 30 days, 6 months, and 12 months post procedure
Individual MACCE Components Through 30 Days, 6 Months, and 12 Months
Individual Components include: All Cause Mortality, Myocardial Infarction (MI), and Severe Stroke.
Assessed by reported adverse events that meet the MACCE criteria and adjudicated by a Clinical Events Committee.
Measured: 30 days, 6 months, and 12 months post procedure
Aorta-related Mortality
Assessed by reported adverse events and adjudicated by a Clinical Events Committee
Measured: 30 days post procedure
Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months
Assessed on CT scans within the defined visits windows
1 Month: 15-59 days post procedure 6 Month: 60-242 days post procedure 12 Month: 243-546 days post procedure
Measured: 30 days, 6 months, and 12 months post procedure
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Assessed on CT scans within the defined visits windows:
1 Month: 15-59 days post procedure 6 Month: 60-242 days post procedure 12 Month: 243-546 days post procedure
Definitions:
Endoleak Type I (A and B): Endoleak arising at or from the prosthesis attachment site perfusing the treated region of the aorta.
Endoleak Type IA: Endoleak at proximal aortic prosthesis attachment site. Endoleak Type IB: Endoleak at distal prosthesis attachment site. Endoleak Type II: Endoleak arising from a patent branch vessel of the excluded aorta perfusing the treated aorta, e.g., lumbar or inferior mesenteric branch.
Endoleak Type III: Endoleak arising from the component junction(s) of the prosthesis or due to a defect in the graft material perfusing the treated region of the aorta.
Endoleak Type IV: Endoleak arising through the graft fabric perfusing the treated region of the aorta.
*Endoleak categorizations have no directionality (i.e., cannot be considered better or worse)
Measured: 30 days, 6 months, and 12 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2015Apr 2026

First posted5 Mar 2015 (estimated)
Study startAug 2015
Primary completion26 Feb 2021
Study completionApr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Aortic DissectionStudies of the same condition, open and under way.
More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02380716
Sponsor's protocol ID: TBE 14-02
Status last verified: Apr 2026
First submitted: 24 Feb 2015
Last updated: 13 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
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RecruitingObservational study
Metabolic Phenotyping in vEDS
Vascular Ehlers-Danlos Syndrome, Vascular Ehlers Danlos Syndrome
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm

All Aortic Dissection trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection
ClinicalTrials.gov ID: NCT02380716
Acronym / sponsor ID: TBE 14-02
Conditions: Aortic Dissection
Keywords: type A dissection
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
Study start: Aug 2015 (actual)
Primary completion: 26 Feb 2021 (actual)
Study completion: Apr 2026 (actual)
First posted: 5 Mar 2015 (estimated)
Results: Posted 27 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft

Detailed description

This study is a prospective, multicenter, non-randomized single-arm study to assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GORE® Ascending Stent Graft	Experimental	Device: GORE® Ascending Stent GraftTreatment with the GORE® Ascending Stent Graft

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

DeBakey Type I/II aortic dissection compatible with the treatment requirements of GORE® Ascending Stent Graft, including:
Able to undergo CT scan per protocol requirements to perform required case planning prior to endovascular procedure
High surgical risk, as determined by the implanting physician
Adequate vascular access via transfemoral or retroperitoneal approach
An Informed Consent Form signed by Subject or legally authorized representative

Key exclusion criteria (16 listed)

Planned aortic valve repair or replacement or coronary artery intervention within 30 days
Presence of mechanical heart valve in the aortic position
Primary entry tear location in the aortic arch or descending thoracic aorta with retrograde flow into the ascending aorta
Aortic insufficiency grade 3+ or 4+
Known irreversible neurological injury

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
GORE® Ascending Stent Graft	Device	GORE® Ascending Stent Graft

Primary outcome

All Cause Mortality at 30 Days Post-procedure
Time frame: 30 days post-procedure
Number of subjects that die of any cause within 30 days post-procedure

6 secondary outcomes

Successful Dissection Treatment (Technical Success)
Time frame: At removal of device deployment system, up to conclusion of procedure
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) Assessed Through 30 Days, 6 Months, and 12 Months
Time frame: 30 days, 6 months, and 12 months post procedure
Individual MACCE Components Through 30 Days, 6 Months, and 12 Months
Time frame: 30 days, 6 months, and 12 months post procedure
Aorta-related Mortality
Time frame: 30 days post procedure
Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months
Time frame: 30 days, 6 months, and 12 months post procedure
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Time frame: 30 days, 6 months, and 12 months post procedure

Results and safety

Results posted to the registry on 27 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GORE® Ascending Stent Graft	21	1

Primary outcome: All Cause Mortality at 30 Days Post-procedure

Time frame: 30 days post-procedure. Count of participants. Unit: Participants

Measure	GORE® Ascending Stent Graft n = 19
Value	3

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through 5 Years or Study Discontinuation/Completion. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GORE® Ascending Stent Graft	19 of 21 (90.5%)	9 of 21 (42.9%)	6 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Aortic Dissection

Not yet recruitingPhase 2
D2 Gastrectomy With or Without Para-Aortic Lymph Node Dissection After Chemoimmunotherapy for Gastric Cancer
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Not yet recruitingObservational study
Clinical Health Outcomes Evaluation of Terumo Aortic Hybrid Devices
Aortic Aneurysm and Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingObservational study
Metabolic Phenotyping in vEDS
Vascular Ehlers-Danlos Syndrome, Vascular Ehlers Danlos Syndrome
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GORE® Ascending Stent Graft in people with Aortic Dissection, run by W.L.Gore & Associates at 1 site in United States.

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 8 inclusion and 16 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: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 27 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

All Cause Mortality at 30 Days Post-procedure (time frame: 30 days post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02380716.

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 13 May 2026.