Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 10:03 AM
Study NCT ID:
NCT02010892
Status:
UNKNOWN
Last Update Posted:
2016-05-06
First Post:
2013-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study
Sponsor:
Papworth Hospital NHS Foundation Trust
Organization:
Study Overview
Official Title:
Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETTAA
Brief Summary:
This is a prospective observational cohort study that will collect data from the point of referral through to secondary care, aiming for 3 years median follow-up (range 1-5 years). The data collected will allow estimation of the success of any intervention (in terms of reducing rate of aneurysm growth, rupture or dissection) as well as estimation of the risks associated with the three procedures. Clinical outcomes in the three treatment groups will be described.
Aims
We aim to answer the following questions:
1. Without procedural intervention for chronic thoracic aortic aneurysm (CTAA), what is the risk of aneurysm growth, dissection, rupture, permanent neurological injury or death? What is the effect on quality of life (QoL)?
2. If a patient has endovascular stent grafting (ESG) or open surgical repair (OSR), what is the risk of growth, dissection, rupture, permanent neurological injury or death?
3. How does QoL change from pre- to post intervention?
4. Can aneurysm or patient related predictors of good/poor treatment outcomes be determined?
5. What is the most cost-effective strategy in:
1. Patients eligible for either ESG or OSR?
2. Patients eligible for either ESG or best medical therapy (BMT)?
3. Patients eligible for either watchful waiting (WW) or intervention (ESG/ OSR)?
6. What further research is required? What would be the most important research to pursue?
Aims
We aim to answer the following questions:
1. Without procedural intervention for chronic thoracic aortic aneurysm (CTAA), what is the risk of aneurysm growth, dissection, rupture, permanent neurological injury or death? What is the effect on quality of life (QoL)?
2. If a patient has endovascular stent grafting (ESG) or open surgical repair (OSR), what is the risk of growth, dissection, rupture, permanent neurological injury or death?
3. How does QoL change from pre- to post intervention?
4. Can aneurysm or patient related predictors of good/poor treatment outcomes be determined?
5. What is the most cost-effective strategy in:
1. Patients eligible for either ESG or OSR?
2. Patients eligible for either ESG or best medical therapy (BMT)?
3. Patients eligible for either watchful waiting (WW) or intervention (ESG/ OSR)?
6. What further research is required? What would be the most important research to pursue?
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 11/147/03 | OTHER_GRANT | NIHR Health Technology Assessment Programme | View |