Objective of the study: The primary objective of this study is to assess the efficacy See primary endpoints, section 7.1 of endoluminal stent grafting and BMT compared to BMT alone in the treatment of uncomplicated acute type B aortic dissections.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters/outcome of the study:
The primary endpoint for this study is a composite of the following events:
Incomplete/no false lumen thrombosis at, aortic dilatation at, or aortic
rupture through the 1-year follow-up visit.
· Incomplete & Complete Thrombosis
· Test Group: Incomplete thrombosis will be defined as the presence of blood
flow in any portion of the false lumen parallel to the stent graft, excluding
the distal 2 cm; Complete thrombosis will be defined as absence of blood flow
in any portion of the false lumen parallel to the stent graft, excluding the
distal 2 cm.; No false lumen thrombosis will be defined as the presence of
blood flow throughout the entire false lumen within the descending thoracic
aorta parallel to the stent graft.
Control Group: Incomplete thrombosis will be defined as the presence of blood
flow in any portion of the false lumen at any point in the descending thoracic
aorta. Complete thrombosis will be defined as absence of blood flow in any
portion of the false lumen at any point in the descending thoracic aorta. No
false lumen thrombosis will be defined as the presence of blood flow throughout
the entire false lumen within the descending thoracic aorta.
· Aortic dilatation will be defined as an increase of *5 mm in the maximum
diameter of the descending thoracic aorta compared to the pre-treatment CT
measurement or the maximum diameter of the descending thoracic aorta *55 mm at
the 1-year follow-up visit
· Aortic rupture will be defined as disruption of the thoracic aorta with fresh
blood outside the adventitia observed on CT, radiograph, or other radiologic
modalities at any time through the 1-year follow-up visit
All randomized patients will be evaluated on an Intent-To-Treat basis. Per
protocol and sensitivity analyses will also be performed. Treatment crossover
before intervention will not be permitted
Secondary outcome
Many variables will be collected during this trial. These will include, but
are not limited to, the following:
* Pre-treatment data
o Demographics, co-morbidities, aortic morphology
* Treatment data
o Access success failure
o Procedure time
o Quantity and size of stents (Test group only)
o Adjunctive procedures
o Incidence of adverse events and device events
* Follow-up data
o Type and dosage of hypertension medication
o Hospital and intensive care unit stay
o Aortic morphology post-treatment including false lumen thrombosis and true
and false lumen diameters
o Incidence of adverse events and device events
o Mortality (all-cause and dissection-related)
Of special interest in this patient population is the incidence of
dissection-related mortality. Dissection-related mortality will be collected
during the study and will be defined as death a) within 30 days of initial
treatment, b) before hospital discharge, c) within 30 days of a secondary
endovascular or surgical intervention, or d) directly caused by the aortic
dissection.
Background summary
Background of the study: Best Medical treatment (association of Bêta bloquers
and diuretics) is the standard treatment for Type B, uncomplicated aortic
dissections, however there is still a high mortality rate and a high
reintervention / complication rate. This study hopes to show the efficacy of
placing a stent graft as first treatment will have fewer complication in short
long term, lower morbidity and fewer re-interventionsObjective of the study:
The primary objective of this study is to assess the efficacy See primary
endpoints, section 7.1 of endoluminal stent grafting and BMT compared to BMT
alone in the treatment of uncomplicated acute type B aortic dissections.
Study objective
Objective of the study:
The primary objective of this study is to assess the efficacy See primary
endpoints, section 7.1 of endoluminal stent grafting and BMT compared to BMT
alone in the treatment of uncomplicated acute type B aortic dissections.
Study design
Study design: Mulicentric, Randomized, Open and European
Intervention
The endovascular procedure will be performed in either an operating room or
catheterization laboratory with angiographic guidance to facilitate device
placement. The exact type of anesthesia administered to allow insertion of the
stent-graft will be selected by the involved
physicians based on the clinical condition of the patient. After the patient
is prepped and draped in the usual sterile manner, surgical dissection and
exposure of the common femoral
or iliac arteries will be performed. If both peripheral vessels are too small
for the required introducer sheath access via a conduit is allowed. Either
needle puncture or surgical arteriotomy will achieve arterial access and an
angiographic catheter will be advanced under fluoroscopic guidance into the
ascending aorta.
Preliminary arteriographic studies are performed to confirm the location of the
primary entry tear of the dissection, and establish the best radiographic view
for monitoring the stent-graft deployment. A guidewire is exchanged for the
catheter and an angiographic sheath of an appropriate size for the selected
stent-graft is co-axially advanced over it. In either case, the device catheter
is tracked over the wire until it reaches a position that bridges the entry
tear. After final positioning over the target is completed, the device is
deployed by pulling a knob adaption adjacent to the catheter hub outside the
patient. The knob is attached to a suture that runs the length of the catheter.
The suture laces a constraining polytetrafluoroethylene corset that secures the
collapsed stent-graft to the catheter shaft. As the knob is smoothly
withdrawn, the suture is released and the corset-like membrane opens from its
middle with instantaneous deployment of the underlying self-expanding
stent-graft proceeding from the center toward both ends. Once fully deployed,
the delivery catheter is removed and post-placement arteriographic imaging is
performed via the angiographic catheter. The procedure is complete if the
desired position over the entry tear is achieved without arteriographic imaging
evidence of incomplete coverage or inadequate sealing of the tear. If there is
inadequate sealing, further procedures may be required which should be
documented. However, if the device is poorly positioned, or not fully expanded,
and if there is a residual antegrade flow through the tear into the false
lumen, supplemental maneuvers, i.e. placement of an additional stent-graft, may
be performed. Upon completion of the procedure, the catheters and sheath are
removed, the artery is repaired, and the incision is closed
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness (if applicable):
The risks for the stent-graft groups are inherent to the procedure and
therefore are the same as for other endovascular prostheses and are not limited
to (incorrect placement, occlusion, distal embolization, infection, migration,
hematoma or vascular lesion at the site of arterial access, paraplegia and
allergies to x-ray dyes used.)
The risks for patients receiving BMT are not limited to: complications
requiring immediate operation (hemothorax, persistent chest pain, extension of
the intimal tear or rupture of the vasa vasorum with hemorrhage), sudden death
(rupture to pericardium, pleural, peritoneal space, shear off coronary artery
allergies to x-ray dyes used)
The risks will be continuously monitored under the aspect of recruitment
cancellation
4100 W. Kiltie Lane Flagstaff, AZ, USA
AZ
US
4100 W. Kiltie Lane Flagstaff, AZ, USA
AZ
US
Listed location countries
Age
Inclusion criteria
Inclusion criteria:
1. Presence of acute uncomplicated type B dissection
acute defined as time from symptom onset to teratment < 14 days
uncomplicated course which includes freedom from:
endorgan ischemia or evidence of malperfusion
paraplegia
rupture or impending rupture
uncontrollable pain
type b dissection where the primary entry tear is entirely distal to the left subclavian artery with only involvement of the distal aorta
aortic dissection is distinguished by radiologic evidence of an intimal flap and dual aortic lumens. Dissection variants such as intramural hematoma and penetrating ulcers are not allowed in this study.
2. maximum transverse diameter of the descending aorta < 55 mm and absence of descending thoracic aortic aneurysm, regardless of etiology
3. arterial anatomy is appropriate for stent graft therapy defined as
- proximal landing zone is not aneurysmal, dissected or significantly thrombosed
- proximal landing zone length > 2.0 cm
- proximal landing zone diameters between 23-42 mm
- non tortuous or non stenotic iliac and or femoral arteries and ability to use a conduit for vascular access.
4. able to tolerate endotracheal intubation and general anesthesia
5. age 18 to 80 years
6. declaration of voluntary participation in the study with signed informed consent form.
7. capable of complying with study protocol requirements, including long term medical treatment with beta blockers, diuretics and or ace inhibitors and follow-up for 3 years post treatment.
Exclusion criteria
Exclusion criteria;1. ASA classification V
2. severe renal insufficiency defined as SVS risk renal status=3
3. severe respiratory insufficiency defined as SVS risk pulmonary status=3
4. presence of connective tissue disease (Marfan, Ehlers-Danlos)
5. active infection of active vasculitides
6. positive pregnancy test
7. participation in another medical research study within 3 months prior of study enrollment
8. myocardial infarction or cerebrovascular accident within 6 weeks prior to study enrollment
9. planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrollment
10. history of drug abuse
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL16249.018.07 |