Werbung
Verfügbare Sprachen
Verfügbare Sprachen
Paresthesia
Pericardial effusion
Renal function insufficiency/kidney failure
Retrograde Type A dissection
Change in mental status
Reverse tearing or rupture of dissection
Shock
Tissue necrosis
Wound complications and subsequent attendant problems
Device complications due to:
Insertion and removal difficulties
Release difficulties
Failure to deploy
Inaccurate placement
Endoleak
Stent migration
Stent fracture
Rupture of graft material
Erosion
Stent thrombosis or embolization
Stent graft expansion
Stent graft twisting or kinking
Note:
For any serious incident, the user or patient should report it
to Lifetech at quality@lifetechmed.com or the local sale
representative of Lifetech and your local Competent
Authority (CA).
7.
Summary of Clinical Data
Three clinical studies of Ankura
been
finished
(one-to-nine-year) follow-up study. These studies aimed to
evaluate the clinical safety and efficacy of the Ankura
Graft Systems for endovascular treatment of thoracic aortic
aneurysm and Stanford B-type dissection, and they met the
predefined primary endpoints of treatment success with few
adverse events.
Study 1
107 patients implanted Ankura
cases, AAA-30 cases, AUI-15 cases) were enrolled in the study
in China. The stent grafts were successfully implanted in all 107
patients (100%). 91 of 106 patients were followed up after the
procedure, and the mean follow-up time was 218 (range 30 –
600) days. Treatment success rate of aortic aneurysm at
6-month post-implant reached 93.4% (85/91). 85 of 91 patients
evaluated for safety events during the follow up were free of a
safety event (93.4%).
Follow-up data showed that:
One out of 107 patients (0.9%) died in-hospital (0.9%), but this
death was unrelated to the device or procedure.
One out of 107 patients (0.9%) had artery stenosis.
One out of 107 patients (0.9%) experienced paraplegia.
One out of 107 patients (0.9%) had renal failure.
Three out of 107 patients (2.8%) experienced early endoleaks.
No patient experienced stent displacement, stent fracture, or
aortic rupture.
Study 2
This was a randomized control trial. A total of 144 patients with
aortic
aneurysm
aneurysm treatment with implantation of stent grafts. 71 (49.3%)
patients were implanted with Ankura
immediate technical success rate was 100%. Of the 65 patients
implanted Ankura
at one year, 58 were free of a safety event (90%).
One-year patient follow-up has detected the following adverse
events: respiratory failure and heart failure (N=1), paraplegia
(N=1), death (N=3), pulmonary infection (N=1), abdominal
distension (N=1). One out of 71 patients implanted the Ankura
TAA stent experienced a device-related adverse event. CTA
follow-up showed no displacement, stent thrombosis, stent
discounts, stent rupture, and the rate of internal leakage.
Study 3
This study retrospectively collected mid-long-term real-world
clinical data from multiple hospitals in China. 305 patients were
enrolled and they completed the mid- and long-term follow-up.
TM
in
China,
TM
or
dissection
TM
TAA stent grafts evaluated for safety events
TAA stent graft system have
including
a
stent graft systems (TAA-62
underwent
TM
TAA stent grafts. The
9
mid-long-term
TM
Stent
endovascular
TM
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