ARISE: First-In-Human Evaluation of a Novel Stent Graft to Treat Ascending Aortic Dissection
Related Experiment Video
Updated: Sep 22, 2025
Novel and Innovative Hybrid Technique for Type A Aortic Dissection
Published on: March 28, 2025
Eric E Roselli1, Marvin D Atkins2, William Brinkman3
1Department of Thoracic and Cardiovascular Surgery, Aortic Center, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, OH, USA.
Insights
The ARISE study shows promising early results for a novel stent graft in treating high-risk ascending aortic dissection patients. This investigational device offers a potential new option for those unsuitable for traditional surgery.
Area of Science:
- Cardiovascular Surgery
- Medical Devices
- Interventional Cardiology
Background:
- Ascending aortic dissection carries a 10-20% operative mortality rate.
- A significant portion of patients are ineligible for open surgical repair.
- The ARISE study investigates a novel GORE® Ascending Stent Graft (ASG).
Purpose of the Study:
- To assess the early feasibility of using the investigational GORE® Ascending Stent Graft (ASG).
- To treat patients with ascending aortic dissection.
Main Methods:
- Prospective, multicenter, non-randomized, single-arm study.
- Enrollment of high-surgical-risk patients with suitable anatomy.
- Transfemoral delivery of the ASG under fluoroscopic guidance.
Main Results:
- Nineteen patients (mean age 75.7 years) with acute DeBakey type I or II dissection were treated.
- Successful device delivery and deployment in all patients.
- 30-day MACCE: 15.8% mortality, 5.3% disabling stroke, 5.3% myocardial infarction.
Conclusions:
- The ARISE early feasibility study demonstrates promising results for the GORE® Ascending Stent Graft.
- The device offers a potential new treatment avenue for ascending aortic dissection.
Background:
Operative mortality for type A aortic dissection is still 10-20% at centers of excellence. Additionally, 10-20% are not considered as viable candidates for open surgical repair and not offered life-saving emergency surgery. ARISE is a multicenter investigation evaluating the novel GORE® Ascending Stent Graft (ASG; Flagstaff, AZ).
Objective:
The purpose of this study is to assess early feasibility of using these investigational devices to treat ascending aortic dissection.
Methods:
This a prospective, multicenter, non-randomized, single-arm study that enrolls patients at high surgical risk with appropriate anatomical requirements based on computed tomography imaging at 7 of 9 US sites. Devices are delivered transfemorally under fluoroscopic guidance. Primary endpoint is all-cause mortality at 30 days. Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days, 6 months, and 12 months.
Results:
Nineteen patients were enrolled with a mean age of 75.7 years (range 47-91) and 11 (57.9%) were female. Ten (52.6%) had DeBakey type I disease, and the rest were type II. Sixteen (84.2%) of the patients were acute. Patients were treated with safe access, (7/19 (36.8%) percutaneous, 10/19 (52.6%) transfemoral, 2/19 (10.5%) iliac conduit), delivery, and deployment completed in all cases. Median procedure time was 154 mins (range 52-392) and median contrast used was 111 mL (range 75-200). MACCE at 30 days occurred in 5 patients including mortality 3/19 (15.8%), disabling stroke in 1/19 (5.3%), and myocardial infarction in 1/19 (5.3%).
Conclusion:
Results from the ARISE early feasibility study of a specific ascending stent graft device to treat ascending aortic dissection are promising.
