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

Aortic Dissection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02380716
• Other study ID #: TBE 14-02
• Status: Active, not recruiting
• Start date: August 2015
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: April 2026
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. Able to undergo CT scan per protocol requirements to perform required case planning prior to endovascular procedure

3. High surgical risk, as determined by the implanting physician

4. Adequate vascular access via transfemoral or retroperitoneal approach

5. An Informed Consent Form signed by Subject or legally authorized representative

6. Able to comply with protocol requirements including follow-up

Exclusion Criteria:

1. Planned aortic valve repair or replacement or coronary artery intervention within 30 days

2. Presence of mechanical heart valve in the aortic position

3. Primary entry tear location in the aortic arch or descending thoracic aorta with retrograde flow into the ascending aorta

4. Aortic insufficiency grade 3+ or 4+

5. Known irreversible neurological injury

6. Known degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome

7. Participation in another drug or medical device study within 1 year of study enrollment

8. Known history of drug abuse

9. Pregnant female at time of informed consent signature

10. Body habitus or other medical condition which prevents adequate visualization of the aorta

11. Systemic infection that could increase the risk of endovascular graft infection

12. Previous thoracic aortic surgery

13. Life expectancy <12 months due to associated non-cardiac co-morbid conditions

14. Subject has known sensitivities or allergies to the device materials

15. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin

16. Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment

Related Conditions & MeSH terms

• Aortic Dissection

Intervention

Device:
• GORE® Ascending Stent Graft

Locations

Country	Name	City	State
United States	University of Southern California- Keck Medicine	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All Cause Mortality at 30 Days Post-procedure	Number of subjects that die of any cause within 30 days post-procedure	30 days post-procedure
Secondary	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.	At removal of device deployment system, up to conclusion of procedure
Secondary	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	30 days, 6 months, and 12 months post procedure
Secondary	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.	30 days, 6 months, and 12 months post procedure
Secondary	Aorta-related Mortality	Assessed by reported adverse events and adjudicated by a Clinical Events Committee	30 days post procedure
Secondary	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	30 days, 6 months, and 12 months post procedure
Secondary	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)**	30 days, 6 months, and 12 months post procedure