The purpose of this study is to investigate the clinical performance of Thoraflex in the treatment of subjects with aneurysm or penetrating ulcer of the descending thoracic aorta.The primary objective of this study is to demonstrate the safety and…
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Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary safety endpoint will be the proportion of subjects who do not
sustain any major adverse events (MAEs) *30 days post-procedure. A MAE is
defined as the occurrence of any of the following:
* Respiratory complications: atelectasis/pneumonia, pulmonary embolism,
pulmonary oedema, respiratory failure.
* Renal complications: renal failure, renal insufficiency.
* Cardiac complications: MI, unstable angina, new arrhythmia, exacerbation of
congestive heart failure.
* Neurological: New CVA/embolic events, paraplegia/paraparesis
* Aneurysm rupture
* Gastrointestinal: bowel ischemia
* Major bleeding complications (procedural or post procedural), coagulopathy
* Vascular complications
* Death due to device or procedure related complications, internal bleeding,
vascular repair, transfusion reaction or conversion to open surgical TAA repair.
The primary effectiveness endpoint will be successful aneurysm treatment,
defined as a composite endpoint of subjects who have successful delivery and
deployment of the ThoraflexTM at the initial procedure and are free from the
following at * 365 days post-procedure:
* Aneurysm growth >5 mm from baseline measurement (Pre-Discharge CT Scan)
* Post-operative interventions to correct type I or III endoleaks
* Conversion to open surgical repair
* Failed patency of the stent graft
* Migration requiring secondary intervention
* Significant failure of stent graft integrity
* Aneurysm rupture
Secondary outcome
Technical Success
Technical success is defined as the introduction and deployment of ThoraflexTM
(with any ancillary endovascular components deemed necessary such as extensions
or stents) in the absence of mortality, conversion to surgical repair, failed
patency or evidence of a type I or III endoleak in the first 24 hour post-
operative period (defined on procedural angiography). Components of technical
success to be evaluated as secondary effectiveness outcomes include:
* Incidence of type I or III endoleak. The incidence of subjects with freedom
from type I and III endoleaks will be the focus of assessments, however type II
and IV endoleaks will be recorded and evaluated for rates of occurrence.
* Stent graft patency, defined as the presence of blood flow within the graft
as determined through imaging analysis.
* Conversion to surgical repair.
These outcomes will also be evaluated throughout the study, however, only
events occurring *24 hours post-procedure will be assessed for technical
success. For example, a type I endoleak discovered at 180 days post-procedure
will not be considered a technical failure, but will be evaluated as a
component measurement. Mortality will be assessed separately as a safety
outcome.
Changes in Aneurysm Size
Aneurysm size will be evaluated pre-procedure and at discharge, 1, 6 and 12
months post-procedure. It is anticipated that in the initial post-implant
period the aneurysm sac may increase slightly in diameter as has been reported
elsewhere for this type of procedure. Therefore, although aneurysm size will
be evaluated at 1 month, this will only be evaluated as a component
measurement.
A significant size change, compared with pre-procedure, will be considered to
be a decrease or increase in diameter >5 mm as measured along the major axis
diameter.
Assessment of Aneurysm Rupture
Aneurysm rupture will be defined as the expansion of the blood vessel to the
extent of leakage of blood into the body cavity as determined from imaging.
Assessment of Stent Graft Migration and Integrity
Stent graft migration will be defined as proximal or distal migration of the
stent graft in excess of 10mm which requires a secondary intervention.
Migration will be evaluated at discharge, 1, 6 and 12 months post-procedure.
Structural Integrity will be assessed primarily by CT scan images and a 3D
reconstruction and will be represented in binomial fashion. The stent graft
will be assessed and described in terms of the integrity of the ring stents,
the fixation hooks, the struts and the fabric graft material. Categories of
stent graft integrity will include intact, fractured, or any failure of the
device components to demonstrate structural integrity.
Assessment of Secondary Interventions
The incidence of secondary intervention following device implantation will be
evaluated at discharge, 1, 6 and 12 months post-procedure. Secondary
interventions may include embolisation of endoleaks, treatment of branch vessel
occlusions, placement of new components as a result of migration and open
conversions.
Acute Procedural Outcomes
Additional clinical endpoints to assess acute procedural outcomes include
duration of procedure and procedural blood loss (volume).
Background summary
The Thoraflex Thoracic Stent Graft System is designed for the treatment of
aneurysm or penetrating ulcer of the descending thoracic aorta. Endovascular
repair of aneurysm or penetrating ulcer of the descending thoracic aortic has
been demonstrated to be a safe and feasible treatment. In addition
endovascular repair may provide a treatment choice to those higher risk
patients who are unsuitable for traditional surgery as it offers a less
invasive treatment option and is well recognised as showing early advantages
and reduced early complications. Despite the recognised benefits, further
research and evidence is needed to determine longer-term outcomes of
endovascular thoracic aortic repair. Potential limitations of current
commercially available systems include the inability to deal with complex
aortic anatomies, the inability to navigate iliac tortuosity and stenosis,
inadequate sealing and fixation and device fracture / fatigue.
In an attempt to overcome these limitations and prove that the long-term
outcomes of endovascular repair of the thoracic aorta are favourable, and as
new treatment systems require robust evaluation before they can be adopted into
clinical practice, a prospective, non-randomised single-arm study has been
designed to evaluate the safety and efficacy of the Thoraflex Thoracic
Endovascular Stent Graft System.
Study objective
The purpose of this study is to investigate the clinical performance of
Thoraflex in the treatment of subjects with aneurysm or penetrating ulcer of
the descending thoracic aorta.
The primary objective of this study is to demonstrate the safety and
effectiveness of Thoraflex in the treatment of subjects with aneurysm or
penetrating ulcer of the descending thoracic aorta.
The secondary objective of this study is to assess the clinical outcomes of
Thoraflex associated with the treatment of aneurysm or penetrating ulcer of the
descending thoracic aorta.
Study design
This is a prospective, non-randomised single-arm study to evaluate the safety
and efficacy of the Thoraflex Thoracic Endovascular Stent Graft System in the
treatment of aneurysm and penetrating ulcer of the descending thoracic aorta.
143 subjects will be recruited from up to 30 centres in Italy, France, Germany,
Netherlands, Belgium, Canada and the UK. All Investigators will be experienced
in the endovascular treatment of patients with thoracic aneurysm or penetrating
ulcer.
Subjects will be evaluated pre-operatively, intra-operatively, at discharge, 30
days, 6, 12, months post-operatively. Each post-operative evaluation will
consist of CT scan and physical examination. This evaluation schedule
represents standard best clinical practice for patients undergoing thoracic
stent graft treatment with an approved device. Therefore, follow up within the
study should confer no additional burden on the study subjects. Adverse event
data will be collected throughout the study.
Success criteria will be:
Safety (freedom from Major Adverse Events)
and
Efficacy (successful aneurysm or ulcer treatment)
Intervention
Endovascular implant of a stent graft. Each stent graft is advanced from a
transfemoral or transiliac approach over a 0.035* guidewire and positioned
under fluoroscopic control. If necessary, an arterial conduit technique may be
required to allow access to the arterial system. The soft tapered tip allows
atraumatic insertion into the vessel, while the catheter and sheath are
designed to provide excellent flexibility and control through tortuous arterial
anatomy.
Each individual stent graft device is supplied sterile and pre-loaded in a
single-use delivery system. The stent graft is a self-expanding endoprosthesis
constructed of a thin wall woven polyester and Nitinol ring stents, which are
attached to the fabric with braided polyester sutures. The delivery system
central catheter is a stainless steel braided co-extrusion of PTFE and
polyester elastomer, designed to provide significant torque control and
strength, while also maintaining superior flexibility. The outer sheath is
made in a tri-layer construction consisting of a PTFE liner, a stainless steel
flat braid layer and a polyester elastomer outer jacket with a hydrophilic
lubricant coating. These materials provide very low friction force during
device insertion and deployment together with enhanced flexibility of the
delivery system. The handle components are moulded from thermoplastic
polyurethane.
The materials of the endoprosthesis are identical to those of the current CE
marked Vascutek Ltd. Anaconda Stent Graft System intended for abdominal aortic
aneurysm repair. The materials of the delivery system are well established in
medical applications. The design and apllication of Thoraflex is based on the
same principles as other clinically established thoracic endovascular devices.
The endoprosthesis is constructed of self-expanding nitinol stents covered by a
fabric tube graft. Four proximal hooks anchor the endoprosthesis within the
aorta. Unlike existing thoracic endovascular devices, the delivery system of
the Thoracic Endovascular Stent Graft System allows repositioning of the
endoprosthesis so that the optimal deployment position can be enhanced.
Study burden and risks
Study subjects will be patients requiring endovascular repair of an aneurysm or
ulcer of the descending thoracic aorta. Preoperative, intraoperative and
postoperative care of study patients follows current best clinical practice.
Therefore, subjects recruited to the study should receive identical care to
those treated outside of the study and experience no additional burden from
participation in the study.
Risks associated with participation in the study relate specifically to this
being the first human in-vivo use of this device. Thoraflex has undergone
comprehensive pre-clinical testing, which includes in vitro and in vivo
evaluation, which demonstrates safety for the intended use.
Newmains Avenue, Inchinnan
Renfrewshire PA4 9RR
UK
Newmains Avenue, Inchinnan
Renfrewshire PA4 9RR
UK
Listed location countries
Age
Inclusion criteria
Patients with aneurysms or penetrating ulcers of the descending thoracic aorta;Main Inclusion criteria:
1.Subject ages > 18 years
2.Subject has a life expectancy of at least 12 months
3.The Subject must meet at least one of the following:
- Descending thoracic fusiform aneurysm, 50mm in diameter or greater.
- Descending thoracic aneurysm that is 4cm or more in diameter that has increased in size by 0.5cm in last 6 months
- Descending thoracic aneurysm with a maximum diameter that exceeds two times the diameter of the non-aneurysmal, adjacent aorta
- Saccular aneurysm in the descending thoracic aorta or Penetrating Atherosclerotic Ulcers (PAUs)
4. The diagnosis is confirmed as thoracic aortic aneurysm or PAU by contrast enhanced CT obtained within the three months prior to implant.
(all 9 inclusion criteria can be found in the protocol section 5.1)
Exclusion criteria
Main exclusion cirteria:
1. Subject has any of the following conditions in his/her descending thoracic aorta:
- Dissections - acute or chronic, in ascending or descending aorta
- Acute Transection or Acute Traumatic Injury
- Pseudoaneurysm (false aneurysm)
- Symptomatic Aneurysm, including ruptured lesions
2. Subject's proximal neck diameter, < 22 or > 35 mm.
3. Subject's distal neck diameter, < 22 or > 35 mm.
4. Subject has prohabitive calcification(>50% circumferential calcification), occulsive disease or tortuosity of intended fixation sites.
(All 25 exclusion criteria can be found in the protocol section 5.2)
Design
Recruitment
Medical products/devices used
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 | NL31772.068.10 |
| Other | not available yet |