The objective of this study is to evaluate the 12-month outcomes of stenting with the Supera Peripheral Stent System (Abbott Vascular) versus endarterectomy in symptomatic (Rutherford 2-4) atherosclerotic lesions in the common femoral artery (CFA) (…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Primary efficacy endpoint at 12 months
To demonstrate the non-inferior efficacy in the group treated with the Supera
stent compared to the group treated with endarterectomy for the treatment of
atherosclerosis in the common femoral artery (CFA). Efficacy is defined as
primary patency: a composite of freedom from clinically-driven target lesion
revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex
ultrasound (DUS) peak systolic velocity ratio (PSVR) >=2.4 or >=50% stenosis as
assessed by an independent DUS core lab in CFA) through 12 months post-index
procedure.
2. Primary safety endpoint at 30 days post-index procedure
To demonstrate superior safety in the group treated with the Supera stent
compared to the endarterectomy group for the treatment of atherosclerosis in
the CFA. Safety is defined as a composite of overall death, cardiac, pulmonary,
renal complications, sepsis, target lesion revascularization (TLR) and
wound-related complications (haematoma, seroma, lymphocele, lymphatic leaks
with lymphatic fistula, surgical site infections (SSIs) (Szilagyi grade I, II
and III)).
Secondary outcome
• Technical success
Supera group: Defined as the ability to cross and stent the lesion to achieve
residual angiographic stenosis no greater than 30%.
Endarterectomy group: defined as the ability to remove the atherosclerotic
plaque with or without patch (interposition grafts are not allowed). In the
imaging subcohort the endarterectomy is considered successful when a residual
stenosis no greater than 30% per visual estimation is confirmed.
• Primary patency in the deep femoral artery (DFA), post-index procedure and at
6-, 12-, 24- and 36-months post-index procedure
Primary patency in the DFA is defined as freedom from an occlusion in the DFA
as assessed by PSV-values. This PSV-value will be assessed pre-procedure,
post-procedure, 6 months and 12 months post-index procedure. At 12 months, the
PSV-value will be core-lab controlled.
• Primary patency at 6, 24 and 36 months
Primary patency is a composite of freedom from clinically-driven target lesion
revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex
ultrasound (DUS) peak systolic velocity ratio (PSVR) >=2.4 or >=50% stenosis as
assessed by DUS in CFA) through 6 months post-index procedure
• TLR at 6-, 12-, 24- and 36-months post-index procedure
TLR is defined as a reintervention to maintain or restore the patency in the
target lesion. TLR is clinically-driven (CD) when the TLR was needed due to
symptoms or drop of ankle brachial index (ABI) of >=20% or >0.15 when compared
to post-procedure
• TVR at 6-, 12-, 24- and 36-months post-index procedure
TVR is defined as a reintervention to maintain or restore the patency in the
target vessel. TVR is clinically-driven (CD) when the TVR was needed due to
symptoms or drop of ankle brachial index (ABI) of >=20% or >0.15 when compared
to post-procedure
• Binary restenosis at 6, 12, 24 and 36 months
Binary restenosis is defined as restenosis confirmed by DUS PSVR >=2.4 or >=50%
stenosis as assessed by angiographic and DUS images. At 12 months, the images
will be core lab controlled.
• Duration of initial hospitalisation stay
Number of hours/days of the initial hospitalisation stay.
• Sustained clinical improvement at 6-, 12-, 24- and 36-months post-index
procedure
Clinical improvement is defined as freedom from major target limb amputation,
TVR, worsening target limb Rutherford class (compared to baseline) and decrease
in target limb ankle brachial index (ABI) or toe brachial index (TBI) >=0.15
(compared to baseline)
• Change in Walking Impairment Questionnaire (WIQ) score from baseline to 6,
12, 24 and 36 months
• Change in target limb Rutherford class from baseline to 6, 12, 24 and 36
months
• Change in target limb resting ABI or TBI from baseline to 6, 12, 24 and 36
months
• All cause death at 6, 12, 24 and 36 months
• Thrombosis at the target lesion at 6, 12, 24 and 36 months
Background summary
Although the open surgery in the CFA territory remains the gold standard
treatment at the moment, more and more data conclude that endovascular
approaches are safer and as efficient therapeutic modalities. Especially
reduction in superficial/deep surgical site infections seems to be a great
advantage, like clearly proven in the first TECCO trial. However, longer term
data as well as head to head compared data in a randomized controlled trial are
mandatory to support the idea of treatment switch from open to endovascular
approach in this challenging common femoral artery area.
This study was set up to meet in this unmet need: the endovascular approach
with the Supera Vascular Mimetic implant will be compared with the
endarterectomy in a randomized controlled trial in terms of non-inferior
efficacy and superior safety.
Study objective
The objective of this study is to evaluate the 12-month outcomes of stenting
with the Supera Peripheral Stent System (Abbott Vascular) versus endarterectomy
in symptomatic (Rutherford 2-4) atherosclerotic lesions in the common femoral
artery (CFA) (Azéma type 2 and 3). This evaluation will be done by means of a
direct randomized controlled head-to-head comparison.
Study design
The SUPERSURG study is a prospective, physician-initiated, multi-centre,
randomized controlled trial to evaluate the efficacy non-inferiority and the
safety superiority of the treatment of atherosclerotic lesions in the common
femoral artery with the Supera Peripheral Stent System compared to
endarterectomy. Eligible patients will be randomized in a 1:1 ratio to
endovascular treatment with the Supera stent or endarterectomy. Patients will
be followed for 36 months.
The target lesion must be either de novo or a non-stented restenotic lesions
located in the common femoral artery, between 1cm proximal to the origin of the
circumflex iliac artery and the proximal (2cm) superficial femoral artery and
deep femoral artery (2cm) (Azéma Type 2 and 3)
Intervention
Endovascular treatment with Supera Peripheral Stent System compared to Common
femoral artery endarterectomy
The trial will randomize 286 patients who are eligible for the study in a 1:1
manner to treatment with either the Supera stent or endarterectomy.
Study burden and risks
The burden on the subjects is miminal. The interventions are Standard of Care,
the frequency of visits ot the clinic are the same as when subject would not
participate in the study, the examinations during the study visits are the same
as if the subject would not participate in the study except for one additional
questionnaire at each study visit. Completion of this questionnaire takes 5-10
minutes.
Please note that post-procedure angiography in a subcohort of 40 subjects will
not be performed in The Netherlands.
Keizer Karellaan 584
Sint-Agatha-Berchem 1082
BE
Keizer Karellaan 584
Sint-Agatha-Berchem 1082
BE
Listed location countries
Age
Inclusion criteria
Clinical inclusion criteria:
CI1. Patient is >=18 years old
CI2. Patient presenting a score from 2 to 4 following Rutherford classification
CI3. Patient is willing to comply with specified follow-up evaluations at the
specified times
CI4. Patient understands the nature of the procedure and provides written
informed consent, prior to enrolment in the study
CI5. Patient has a life expectancy of at least 12 months
CI6. Prior to enrolment, the guidewire has crossed the target lesion in the
endovascular arm. In the surgical arm, the CFE needs to be performed with
primary suture or patch implantation.
Angiographic inclusion criteria
AI1. De novo stenotic or restenotic (post-PTA) lesions (<100%) located in the
common femoral artery, suitable for both endovascular therapy and endarterectomy
AI2. Target lesion is located within the native CFA: localized between 1cm
proximal to the origin of the circumflex iliac artery and the proximal (2cm)
superficial femoral artery and deep femoral artery (2cm) (Azéma type 2 and 3
lesions)
AI3. There is angiographic evidence of a patent deep femoral artery and/or
superficial femoral artery
AI4. The target lesion has angiographic evidence of >50% stenosis. Occlusions
are not allowed
Exclusion criteria
Clinical exclusion criteria
CE1. Presence of another stent in the target vessel that was placed during a
previous procedure
CE2. Previous open surgery in the ipsilateral groin
CE3. Patients contraindicated for antiplatelet therapy, anticoagulants or
thrombolytics
CE4. Patients who exhibit persistent acute intraluminal thrombus at the target
lesion site
CE5. Patients with known hypersensitivity to nickel-titanium and heparin,
including those patients who have had a previous incidence of heparin-induced
thrombocytopenia (HIT) type II
CE6. Known allergy to contrast media that cannot be adequately pre-medicated
prior to study procedure
CE7. Patients with uncorrected bleeding disorders
CE8. Female patients with child bearing potential not taking adequate
contraceptives or currently breastfeeding
CE9. Ipsilateral inflow (aorto-iliac) artery treatment before target lesion
treatment with a residual stenosis >30%
CE10. Use of thrombectomy, atherectomy or laser device during procedure
CE11. Any patient considered to be hemodynamically unstable at onset of
procedure
CE12. Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic
malignancy, dementia, etc.) or other medical condition that would prelude non
compliance with the study protocol or 1-year life expectancy
CE13. Major distal amputation (above the ankle) in the study limb or non-study
limb
Angiographic exclusion criteria
AE1. Target lesion involves an (pseudo-)aneurysm or is adjacent to an
(pseudo-)aneurysm (within 5mm)
AE2. Iliac inflow disease requiring treatment, unless the iliac artery disease
is successfully treated first during the index procedure. Success is defined as
<=30% residual diameter stenosis without death or major complications
AE3. Presence of an aortic, iliac or femoral artificial graft
AE4. Occlusion in the target lesion
AE5. Presence of an interposition graft with/without profunda reimplantation
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 |
|---|---|
| ClinicalTrials.gov | NCT04349657 |
| CCMO | NL73200.068.20 |