Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT01197651
Status:
COMPLETED
Last Update Posted:
2016-06-21
First Post:
2010-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aortic-Stent-Register
Sponsor:
Stiftung Institut fuer Herzinfarktforschung
Organization:
Study Overview
Official Title:
Aortenstent-Register Thorakale Aorta
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
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:
None
Brief Summary:
The aims of the aorta-stent-Registry are:
• participating hospitals (with audit) document all consecutive patients diagnosed with a disease of the distal thoracal aorta that receive one of the following therapies:
• participating hospitals (with audit) document all consecutive patients diagnosed with a disease of the distal thoracal aorta that receive one of the following therapies:
Detailed Description:
1. Endovascular Aorta-Stent-Graft
2. Surgical operation of the distal thoracal aorta
* Documentation of the indications, the procedural results and the clinical short- and long-term results of the endovascular and chirurgical treatment in day to day hospital routine.
* Documentation of the operational risk (Euroscore)
* Documentation of the technical enforcement of the procedure as well as the result of the intervention
* Documentation of the hospital lethality and the non-fatal serious complications (Spinal Cord Ischemia, SCI, Stroke, TIA, high blood loss etc.)
* Documentation of medication at hospital discharge
* Documentation of long-term lethality and non-fatal serious complications (SCI, Stroke, TIA, major bleeding etc.) as well as hospitalization, re-intervention rates and medicinal drug therapy after 30 days, 1, 3 \& 5 years.
2. Surgical operation of the distal thoracal aorta
* Documentation of the indications, the procedural results and the clinical short- and long-term results of the endovascular and chirurgical treatment in day to day hospital routine.
* Documentation of the operational risk (Euroscore)
* Documentation of the technical enforcement of the procedure as well as the result of the intervention
* Documentation of the hospital lethality and the non-fatal serious complications (Spinal Cord Ischemia, SCI, Stroke, TIA, high blood loss etc.)
* Documentation of medication at hospital discharge
* Documentation of long-term lethality and non-fatal serious complications (SCI, Stroke, TIA, major bleeding etc.) as well as hospitalization, re-intervention rates and medicinal drug therapy after 30 days, 1, 3 \& 5 years.
Study Oversight
Has Oversight DMC:
False
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?: