Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging With 'Minimally-Invasive Segmental Artery Coil-Embolization': A Randomized Controlled Multicentre Trial - PAPAartis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Aneurysm, Thoracoabdominal
- Sponsor
- University of Leipzig
- Enrollment
- 500
- Locations
- 29
- Primary Endpoint
- The primary objective is to greatly reduce incidence of ischaemic spinal cord injury and mortality.
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
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, i.e. 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 1:1 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 plugs.This 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.
Investigators
David Petroff
Dr. David Petroff [Prof. Dr. Christian Etz]
University of Leipzig
Eligibility Criteria
Inclusion Criteria
- •TAAA, Crawford type II or III
- •planned open or endovascular repair of aneurysm within four months
- •≥ 18 years old
Exclusion Criteria
- •complicated (sub-) acute type B aortic dissection
- •ruptured and urgent aneurysm (emergencies)
- •untreated aortic arch aneurysm
- •bilaterally occluded iliac arteries or chronic total occlusion of left subclavian artery
- •pre-operative neurological deficits or spinal cord dysfunction
- •major untreated cardio-pulmonary disease
- •life-expectancy of less than one year
- •high risk for segmental artery embolism
- •severe contrast agent allergy, severe reduction in glomerular filtration rate (CKD stage 4)
- •expected lack of compliance
Outcomes
Primary Outcomes
The primary objective is to greatly reduce incidence of ischaemic spinal cord injury and mortality.
Time Frame: 30 days after TAAA repair
Successful treatment of the aneurysm is a binary variable. All of the following criteria must be met for this composite endpoint to count as a success: * The patient is alive and without substantial spinal cord injury 30 days after treatment, and * the aneurysm did not rupture and has been excluded within six months of randomization. Substantial spinal cord injury will be determined with a modified Tarlov scale (see below).
Secondary Outcomes
- spinal cord injury according to the modified Tarlov scale from TAAA repair to one year(from date of TAAA repair and up to one year after TAAA repair)
- mortality(at 30 days and one year after TAAA repair)
- sub-group analyses(up to one year after TAAA repair)
- re-operation for bleeding(from date of TAAA repair and up to one year after TAAA repair)
- substantial spinal cord injury(30 days after TAAA repair and at one year after TAAA repair)
- stay in intensive care unit and intermediate care(from date of TAAA repair and up to one year after TAAA repair)
- cross-clamping times(during open surgery)
- residual aneurysm sac perfusion(up to one year after TAAA repair)
- costs(up to one year after TAAA repair)
- Quality Adjusted Life Years(up to one year after TAAA repair)