Surgery vs Surveillance for Thoracic Aortic Aneurysm
(TITAN:SvS Trial)
Recruiting in Palo Alto (17 mi)
+20 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ottawa Heart Institute Research Corporation
Disqualifiers: Previous cardiac surgery, Connective tissue disease, Genetic aortopathies, Inflammatory arteritis, others
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This trial compares early surgery to close monitoring for adults with a slightly enlarged main artery from the heart. The goal is to see which approach better prevents serious complications like tearing or rupture.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the treatment Thoracic Aortic Surgery, Thoracic Aortic Repair, Thoracic Endovascular Aortic Repair (TEVAR), Open Thoracic Aortic Surgery?
Research shows that thoracic endovascular aortic repair (TEVAR) is often preferred over open surgery because it generally leads to fewer complications and lower death rates for patients with thoracic aortic diseases.
12345Is thoracic endovascular aortic repair (TEVAR) generally safe for humans?
TEVAR has been used for over a decade and is considered a standard treatment for thoracic aortic diseases. It is often preferred over open surgery because it tends to have lower risks of complications and death, although there can be late complications that sometimes require further surgery.
26789How does thoracic aortic surgery differ from other treatments for thoracic aortic aneurysm?
Thoracic aortic surgery, including both open surgical repair and thoracic endovascular aortic repair (TEVAR), is unique because it directly addresses the aneurysm by either replacing the affected section of the aorta or reinforcing it with a stent. TEVAR is less invasive than open surgery, but it requires lifelong surveillance due to potential complications, whereas open surgery may have better long-term outcomes but involves a more invasive procedure.
310111213Eligibility Criteria
This trial is for adults aged 18-79 with an ascending aortic aneurysm measuring between 5.0 and 5.4 cm, who can provide informed consent and commit to follow-up. It excludes those unfit for surgery, with certain medical conditions or previous cardiac surgeries, pregnant women, or those with rapid aneurysm growth.Inclusion Criteria
I am between 18 and 79 years old.
My aortic aneurysm is between 5.0cm and 5.4cm in size.
My aortic aneurysm is being monitored and will be eligible for the trial once it reaches 5.0 cm.
Exclusion Criteria
I am pregnant or planning to become pregnant.
I am unable to understand or sign the consent form.
You have a known connective tissue disease, such as Marfan syndrome, Loey-Dietz syndrome, or Turner syndrome.
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Randomization and Pre-treatment
Patients are randomized to either the early surgery group or the surveillance group. Baseline assessments and pre-randomization evaluations are conducted.
10-12 weeks
1 visit (in-person)
Treatment/Surveillance
Patients in the surgery group undergo elective aortic surgery, while those in the surveillance group are monitored with CT scans and medical therapy.
2 years
Annual visits (in-person or virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment or surveillance, with assessments of mortality and acute aortic events.
2 years
Annual visits (in-person or virtual)
Participant Groups
The TITAN SvS trial randomly assigns patients to either early elective surgery to replace the enlarged part of the aorta or close monitoring (surveillance). The goal is to see which approach better reduces death and aortic tearing/rupture after two years.
2Treatment groups
Experimental Treatment
Active Control
Group I: Surgery/Treatment ArmExperimental Treatment1 Intervention
Patients in the Operative Registry will have thoracic aortic surgery
Group II: Surveillance ArmActive Control1 Intervention
Patients in the Non-Operative Registry will be followed in clinic annually with a CT scan to monitor the status of their ascending aortic aneurysm, until the end of the study, the occurrence of an aortic event, or death.
Thoracic Aortic Surgery is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Thoracic Aortic Surgery for:
- Thoracic aortic aneurysm
- Ascending aortic aneurysm
- Descending thoracic aortic aneurysm
🇪🇺 Approved in European Union as Thoracic Aortic Surgery for:
- Thoracic aortic aneurysm
- Ascending aortic aneurysm
- Descending thoracic aortic aneurysm
🇨🇦 Approved in Canada as Thoracic Aortic Surgery for:
- Thoracic aortic aneurysm
- Ascending aortic aneurysm
- Descending thoracic aortic aneurysm
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Institut universitaire de cardiologie et de pneumologie de QuébecQuébec, Canada
Toronto General HospitalToronto, Canada
University of Ottawa Heart InstituteOttawa, Canada
University of MichiganAnn Arbor, MI
More Trial Locations
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Who Is Running the Clinical Trial?
Ottawa Heart Institute Research CorporationLead Sponsor
University of CalgaryCollaborator
References
Thoracic EndoVascular Stent Graft Repair for Aortic Aneurysm. [2022]The number of cases employing thoracic endovascular aortic repair (TEVAR) has been increasing due to lower morbidity and mortality compared to open repair technique. The aim of this study is to evaluate the outcome of TEVAR for thoracic aortic diseases.
The Clinical Impact of Thoracic Endovascular Aortic Repair in the Management of Thoracic Aortic Diseases. [2023]Thoracic endovascular aortic repair (TEVAR) has been described to be superior to an open surgical approach, and previous studies have found superiority in TEVAR by reducing overall morbidity and mortality rates. This study aimed to describe the outcomes of TEVAR for patients with thoracic aortic disease at a high complexity.
Endovascular Versus Open Repair of Intact Descending Thoracic Aortic Aneurysms. [2020]For the management of descending thoracic aortic aneurysms, recent evidence has suggested that outcomes of open surgical repair may surpass thoracic endovascular aortic repair (TEVAR) in as early as 2 years.
Endovascular aortic repair versus open surgical repair for descending thoracic aortic disease a systematic review and meta-analysis of comparative studies. [2018]The purpose of this study was to determine whether thoracic endovascular aortic repair (TEVAR) reduces death and morbidity compared with open surgical repair for descending thoracic aortic disease.
Outcomes after endovascular or open repair for degenerative descending thoracic aortic aneurysm using linked hospital data. [2014]The population-based effectiveness of thoracic endovascular aortic repair (TEVAR) versus open surgery for descending thoracic aortic aneurysm remains in doubt.
Long-Term Outcomes and Risk Factors Analysis for Patients Undergoing Thoracic Endovascular Aorta Repair (TEVAR), According to the Aortic Pathologies. [2023]Thoracic endovascular aortic repair (TEVAR) has become a standard treatment for acute and chronic thoracic aorta diseases. We analyzed long-term outcomes and risk factors of TEVAR procedures according to the aortic pathology.
Thoracic endovascular aortic repair--indications and evidence. [2022]Since its introduction more than a decade ago, thoracic endovascular aortic repair (TEVAR) has shown promising results for patients with various thoracic aortic diseases. The aim of the current review is to assess the current literature to evaluate the safety and efficacy of TEVAR.
Open aortic repair after prior thoracic endovascular aortic repair. [2014]Thoracic endovascular aortic repair (TEVAR) has been applied to increasingly complex aortic pathology, resulting in an increase in late complications. We characterized patients undergoing open repair after prior TEVAR including indications, operative techniques, and outcomes.
A Review of the Endovascular Management of Thoracic Aortic Pathology. [2015]Thoracic endovascular aortic repair (TEVAR) has recently gained popularity, but there is ongoing debate surrounding its safety and efficacy. We present 13 years of TEVAR experience at our institution.
Open versus endovascular repair of thoracic aortic aneurysms: a Nationwide Inpatient Sample study. [2014]Endovascular repair of descending thoracic aortic aneurysms has become an acceptable surgical option over the past decade. We sought to compare the results of open versus endovascular repair of thoracic aortic aneurysms (TEVAR) in the United States.
The role of mandatory lifelong annual surveillance after thoracic endovascular repair. [2012]Thoracic endovascular aortic repair (TEVAR) has become an attractive and well-accepted option for the management of the various thoracic aortic pathologies that vascular surgeons are confronted with. As in the abdominal aorta, current management trends include the treatment of younger patients with longer life expectancies, raising the issue of postoperative surveillance. There are several relevant differences between these anatomic areas when it comes to surveillance, including the relative inaccessibility of the thoracic aorta to ultrasound interrogation and the increased variability of thoracic aortic pathologies and post-TEVAR complications. In addition, concerns regarding radiation-induced carcinogenesis and contrast-induced nephropathy reduce the enthusiasm of many surgeons for regular computed tomography surveillance. Most agree that surveillance is important after TEVAR, but the method, duration, and frequency of that surveillance is much less clear and is the topic of this debate.
Effectiveness of endovascular versus open surgical repair for thoracic aortic aneurysm: a systematic review and meta-analysis. [2022]Since the approval, the thoracic endovascular aortic repair (TEVAR) is widely used for the repair of thoracic aortic aneurysm. However, the long-term mortality and re-intervention rates compared to open surgical repair (OSR) are unclear. We aimed to compare the effectiveness of TEVAR with OSR specifically for thoracic aortic aneurysms.
Costs of endovascular and open repair of thoracic aortic aneurysms. [2023]Repair of thoracic aortic aneurysms with either endovascular repair (TEVAR) or open surgical repair (OSR) represents major surgery, is costly and associated with significant complications. The aim of this study was to establish accurate costs of delivering TEVAR and OSR in a cohort of UK NHS patients suitable for open and endovascular treatment for the whole treatment pathway from admission and to discharge and 12-month follow-up.