Both the Supera and the Absolute Pro Stent System are self-expandable stents that are frequently used in regular clinic practice in patients with obstructive vascular disease. Results of both stent systems have been evaluated in several studies and…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Absence of binary restenosis (* 50% re-obstruction) of the target lesion as
assessed by duplex ultrasound after 12 months without interval clinically
driven reintervention
- Number of clinically driven target lesion revascularisation within 12 months
Secondary outcome
- Changes in pain-free walking distance and absolute walking distance as
assessed by standardized exercise test
- Changes in quality of life as assessed by EuroQol 5 Demension (EQ-5D)
questionnaire
- Clinical complications (number of adverse events, serious adverse events and
major adverse events)
- Sustained clinical improvement as assessed by distribution of Rutherford
stages
- Procedural success (technical success, device success and procedural
complications)
Background summary
Previous studies on stenting of femoro-popliteal arteries are often
representing the results of a single device. Not many studies are comparing the
performance of different stent types in a prospectively randomised setting. Two
flexible stent types with good performance and high patency rates in the
femoro-popliteal artery are the Supera and the Absolute Pro Stent Systems (both
from Abbott Vascular) with 1 year primary patency rates of 78% and 83.3-85.8%
respectively.
Study objective
Both the Supera and the Absolute Pro Stent System are self-expandable stents
that are frequently used in regular clinic practice in patients with
obstructive vascular disease. Results of both stent systems have been evaluated
in several studies and the results have been published.
Although both stent systems show a good performance, head-to-head comparison of
both stent systems is not well possible, due to different study designs,
different outcome measurements and differences in in- and exclusion criteria.
Head-to-head comparison of 2 stent systems is not (yet) very common in the
field of Vascular Surgery, but very common in Cardiology to assess superiority
of either one of the systems.
The aim of this study is to compare the performance and clinical outcome of the
Absolute Pro and the Supera Stent System in symptomatic PAD patients
(Rutherford 2-4) with femoro-popliteal lesions.
Study design
A single centre randomised controlled feasibility study
Intervention
Randomisation between Supera and Absolute Pro stenting
Study burden and risks
For this study the risks for PTA with stenting are applicabale. Though,
patients that will be asked for this study will receive PTA with stenting
anyway, even if they do not want to participate in this study. The burden
includes completing a questionnaire (3 times) and whether or not additional to
a maximum of 2 times 2 non-invasive tests to determine the stent and artery
patency.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
- PAD (ABI <0.90 and/or a decline of >0.15 after exercise test), Rutherford category 2, 3 or 4
- Significant stenoses (* 50%) and/or occlusions in the superficial femoral artery and/or popliteal artery (P1)
- Eligible for endovascular treatment according to international guidelines (with the expectation of stenting after PTA)
- Adequate inflow (<50% stenosis) either pre-existing or successfully re-established prior to target lesion treatment without complications (e.g. embolization, thrombotic event, perforation, etc.)
- Age * 18
Exclusion criteria
- Patients with PAD Rutherford category 5 and 6
- Contralateral lesions that require treatment within 30 days before or after the procedure
- Contra-indication for anticoagulant therapy
- Life expectancy < 1 year
- Known contrast allergy
- Pregnancy
- Unable to complete a questionnaire in the home language
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 | NL53101.100.15 |