Ignite Creation Date:
2024-05-06 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03434314
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2018-01-12
Brief Title:
Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging
Sponsor:
University of Leipzig
Organization:
University of Leipzig
Study Overview
Official Title:
Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging With Minimally-Invasive Segmental Artery Coil-Embolization A Randomized Controlled Multicentre Trial - PAPAartis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
PAPAartis
Brief Summary:
Aortic aneurysms represent the most common and dangerous aortic diseases Although conventional aortic repair techniques cure the disease there is a high risk of paraplegia particularly in extensive thoracoabdominal aneurysms due to impaired blood supply to the spinal cord
The PAPA-ARTiS trial will assess the clinical safety and efficacy of the MISACE Minimally-Invasive Segmental Artery Coil-Embolization procedure a novel therapeutic concept to reduce the risk of paraplegia due to aneurysm repair
The study investigates the MISACE procedure as a potential pre-treatment prior to open or endovascular aneurysm repair in patients with thoracoabdominal aortic aneurysms Patients will be randomized to one of the two treatment strategies a aneurysm repair without MISACE pre-treatment or b aneurysm repair with MISACE pre-treatment
The PAPA-ARTiS trial will assess the clinical safety and efficacy of the MISACE Minimally-Invasive Segmental Artery Coil-Embolization procedure a novel therapeutic concept to reduce the risk of paraplegia due to aneurysm repair
The study investigates the MISACE procedure as a potential pre-treatment prior to open or endovascular aneurysm repair in patients with thoracoabdominal aortic aneurysms Patients will be randomized to one of the two treatment strategies a aneurysm repair without MISACE pre-treatment or b aneurysm repair with MISACE pre-treatment
Detailed Description:
Chronic aortic aneurysms are permanent and localized dilations of the aorta that remain asymptomatic for long periods of time but continue to increase in diameter before they eventually rupture Left untreated the patients prognosis is dismal since the internal bleeding of the rupture brings about sudden death Although successful treatment cures the disease the risky procedures compromise spinal cord blood supply acutely and permanently frequently leading to paraplegia particularly for aneurysms involving crucial segmental arteries ie thoracoabdominal aortic aneurysms of Crawford type II III Although various strategies have achieved a remarkable decrease in the incidence of paraplegia it is still no less than 10-20
However it has recently been found that the deliberate staged occlusion of the segmental arteries to the paraspinous collateral network finally supplying the spinal cord can trigger arterial collateralization thus stabilizing blood supply from alternate inflow sources and preventing ischaemia
This has been translated to a clinically available therapeutic option minimally invasive staged segmental artery coil embolization MISACE which proceeds in a staged manner to occlude groups of arteries under highly controlled conditions after which time must be allowed for arteriogenesis to build a robust collateral blood supply
PAPA-ARTiS is a multi-national prospective open-label two-arm randomized controlled trial to demonstrate that a minimally invasive staged treatment approach can reduce paraplegia and mortality in patients undergoing thoracoabdominal aortic aneurysm TAAA repair
Patients with planned aneurysm repair will be included in the study and will be randomized 11 in the control group or the MISACE-group The control group receives treatment as per standard institutional protocol - open or endovascular repair without MISACE In the MISACE-group segmental arteries will be occluded in one to three sessions some weeks before the definite repair Segmental arteries are occluded with coils or plugsThis induces arteriogenesis and the building of a robust collateral network ultimately supplying the spinal cord During aneurysm repair these new arteries provide an alternate blood supply to the spinal cord and thereby help prevent paraplegia
However it has recently been found that the deliberate staged occlusion of the segmental arteries to the paraspinous collateral network finally supplying the spinal cord can trigger arterial collateralization thus stabilizing blood supply from alternate inflow sources and preventing ischaemia
This has been translated to a clinically available therapeutic option minimally invasive staged segmental artery coil embolization MISACE which proceeds in a staged manner to occlude groups of arteries under highly controlled conditions after which time must be allowed for arteriogenesis to build a robust collateral blood supply
PAPA-ARTiS is a multi-national prospective open-label two-arm randomized controlled trial to demonstrate that a minimally invasive staged treatment approach can reduce paraplegia and mortality in patients undergoing thoracoabdominal aortic aneurysm TAAA repair
Patients with planned aneurysm repair will be included in the study and will be randomized 11 in the control group or the MISACE-group The control group receives treatment as per standard institutional protocol - open or endovascular repair without MISACE In the MISACE-group segmental arteries will be occluded in one to three sessions some weeks before the definite repair Segmental arteries are occluded with coils or plugsThis induces arteriogenesis and the building of a robust collateral network ultimately supplying the spinal cord During aneurysm repair these new arteries provide an alternate blood supply to the spinal cord and thereby help prevent paraplegia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ET 1272-1 | OTHER_GRANT | German Research Foundation | None |
| 733203 | OTHER_GRANT | None | None |