Low-profile versus standard-profile multibranched thoracoabdominal aortic stent grafts.
Bala Ramanan, Charlene C Fernandez, Julia D Sobel...
https://pubmed.ncbi.nlm.nih.gov/26994953/Actively Recruiting
Led by Warren J. Gasper, MD · Updated on 2026-03-05
250
Participants Needed
2
Research Sites
N/A
Total Duration
This research evaluates the safety and effectiveness of endovascular treatment for thoracoabdominal TAAA and paravisceral abdominal aortic aneurysms PVAAA. These aneurysms are abnormal enlargements of the aorta in the chest and abdomen. The study compares a less invasive investigational operation to the standard open surgery, aiming to reduce pain and complications while addressing an unknown success rate of the new approach. The investigational treatment involves placing a branched stent-graft inside the aorta through small incisions in both groins and the right arm. Tubes are inserted through the femoral and brachial arteries to position the graft, which is secured with metal springs called stents. This method may offer advantages like less pain, shorter hospital stay, and fewer pulmonary or cardiac complications compared to traditional open surgery. Participants will undergo the endovascular procedure and be followed up to assess successful graft implantation after one month and long-term treatment success over five years. Researchers will monitor safety, treatment effectiveness, and patient recovery. Participants need to comply with follow-up visits and evaluations throughout the study to help determine the outcomes and potential benefits of this less invasive approach.
CONDITIONS
Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
W
Warren J Gasper, MD
M
Madeleine L Clinch
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Warren J. Gasper, MD
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Endovascular Branched Stent-Graft | Open Surgical Repair (Current Standard) |
|---|---|---|
| What it is | A minimally invasive, industry-manufactured stent-graft with branched design inserted endovascularly to repair thoracoabdominal or paravisceral aortic aneurysms. | Traditional open operation where the aneurysmal segment is replaced with a surgical graft to exclude the aneurysm and restore flow through the aorta and its major branches. |
| Role in study or care | Investigational treatment under prospective clinical evaluation in eligible adults with aortic aneurysm. | Established standard of care for definitive aneurysm repair outside of trial settings. |
| Primary use | Repair of thoracoabdominal or paravisceral abdominal aortic aneurysms in patients at increased procedural risk or with complex anatomy. | Surgical treatment to prevent rupture and life-threatening bleeding from large or symptomatic thoracoabdominal or paravisceral aortic aneurysms. |
| How it is given or performed | Stent-graft is delivered through the arteries via a minimally invasive endovascular approach with branching components for affected vessels. | A large abdominal or thoracic incision allows direct replacement of the diseased aorta with a surgical tube graft, connecting branch vessels individually to preserve organ blood flow. |
| Evidence status | Clinical durability and safety under prospective investigation; published case series and multicenter studies show successful repair in selected patients, but evidence is less mature than for open repair. | Supported by extensive clinical experience and large patient series; long-term outcomes well reported and historically used as the reference standard in this setting. |
| Important limitations | Limited to patients with appropriate vascular anatomy; long learning curve, device evolution, and possible device- or branch-related complications. Long-term outcomes are less thoroughly established compared with open repair. | Major open surgery carries significant operative risk, requires a longer recovery, higher risk of serious complications in high-risk or older patients, and is unsuitable for some with comorbidities. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay duration (varies per participant)
Participants undergo the investigational endovascular operation where small incisions are made in both groins and the right arm to place a branched stent-graft in the aorta through tubes inserted via the femoral and brachial arteries.
1 hospital visit for the procedure
Duration - Up to 5 years
Participants are monitored for the success of the stent-graft implantation and longer-term outcomes.
Regular follow-up visits with assessments over 5 years
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Lead Sponsor