Peripheral Arterial DiseaseSUPERSURG-RCTNCT04349657
A Study Evaluating the Endovascular Treatment of Subjects With Stenotic or Restenotic Lesions of the Common Femoral Artery With the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy
A study testing Supera Peripheral Stent System treatment group and Endarterectomy treatment group in people with Peripheral Arterial Disease, run by KANDO Research at 13 sites in 3 countries.
Trial summary
The SUPERSURG RCT trial investigates the efficacy and safety of the endovascular treatment of stenosis or restenosis in the common femoral artery (CFA) of patients presenting with Rutherford classification 2,3 or 4 with a Supera Vascular Mimetic Implant of Abbott, compared to classic surgical common femoral artery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Supera Peripheral Stent System treatment group and Endarterectomy treatment group
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 5 May 2020to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥18 years old
- Patient presenting a score from 2 to 4 following Rutherford classification
- Patient is willing to comply with specified follow-up evaluations at the specified times
- Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- Patient has a life expectancy of at least 12 months
- Prior to enrolment, the guidewire has crossed the target lesion in the endovascular arm. In the surgical arm, the endarterectomy needs to be performed with primary suture or patch implantation
Show all 10Show fewer
- De novo stenotic or restenotic (post-PTA) lesions (<100%) located in the common femoral artery, suitable for both endovascular therapy and endarterectomy
- 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)
- There is angiographic evidence of a patent deep femoral artery and/or superficial femoral artery
- The target lesion has angiographic evidence of >50% stenosis. Occlusions are not allowed.
Who cannot join
- Presence of another stent in the target vessel that was placed during a previous procedure
- Previous open surgery in the ipsilateral groin
- Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
- Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
- 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
- Known allergy to contrast media that cannot be adequately pre-medicated prior to study procedure
Show all 18Show fewer
- Patients with uncorrected bleeding disorders
- Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
- Ipsilateral inflow (aorto-iliac) artery treatment before target lesion treatment with a residual stenosis >30%
- Use of thrombectomy, atherectomy or laser device during procedure
- Any patient considered to be hemodynamically unstable at onset of procedure
- Severe medical comorbidities (untreated coronary artery disease/congestive heart failure, severe chronic obstructive pulmonary disease, metastatic malignancy, dementia, etc.) or other medical condition that would prelude compliance with the study protocol or 1-year life expectancy
- Major distal amputation (above the ankle) in the study limb or non-study limb
- Target lesion involves an (pseudo-)aneurysm or is adjacent to an (pseudo-)aneurysm (within 5mm)
- 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
- Presence of an aortic, iliac or femoral artificial graft
- Occlusion in the target lesion
- Presence of an interposition graft with/without profunda reimplantation
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Belgium7 sites
O.L.V. Hospital
Aalst, 9300
Imelda Hospital
Bonheiden, 2820
A.Z. Sint-Blasius
Dendermonde, 9200
Z.O.L.
Genk, 3600
Az Groeninge
Kortrijk, 8500
AZ Sint-Maarten
Mechelen, 2800
A.Z. Jan Portaels
Vilvoorde, 1800
Netherlands4 sites
Noordwest ziekenhuisgroep
Alkmaar, 1815
Dijklander hospital
Hoorn, North Holland, 1624
Maastricht UMC+
Maastricht, Limburg, 6229
St Antonius Hospital
Utrecht, Utrecht, 3543
Poland2 sites
Bonifraterskie Centrum Medyczne
Krakow, 31-061
Karol Marcinkowski Medical University
Poznan, 61-848
About this study
Official title: An RCT Evaluating the Safety and Efficacy of the Endovascular Treatment of Subjects With Stenotic or Restenotic Lesions of the Common Femoral Artery With the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy
The SUPERSURG RCT trial investigates the efficacy and safety of the endovascular treatment of stenosis or restenosis in the common femoral artery (CFA) of patients presenting with Rutherford classification 2,3 or 4 with a Supera Vascular Mimetic Implant of Abbott, compared to classic surgical common femoral artery endarterectomy. The Supera Vascular Mimetic Implant has an interwoven design and has a high crush resistance and is, when correctly implanted, an ideal stent to treat eccentric calcified plaques in the CFA.
An expected total of 143 patients will be treated with the Vascular Mimetic Implant of Abbott and compared to a control group of another 143 patients that will be treated with classic surgical endarterectomy of the common femoral artery. Assignment to the treatment groups will be at random.
Read more
Patients will be invited for a follow-up visit at 1, 6, 12, 24 and 36 months post-procedure.
The primary efficacy endpoint is defined as follows: freedom from clinically-driven target lesion revascularization and binary restenosis at 12 months. The primary safety endpoint is defined as follows: a composite of overall death, cardiac, pulmonary, renal complications, sepsis, target lesion revascularisation and wound related complications through 30 days post-index procedure.
The secondary endpoints are defined as technical success, primary patency in the deep femoral artery, primary patency in the target lesion, target lesion revascularisation, target vessel revascularisation, binary restenosis, duration of initial hospital stay, sustained clinical improvement, change of walking impairment questionnaire score from baseline, change in target limb Rutherford classification, change in target limb ABI/TBI from baseline, all cause death, thrombosis at the target lesion through 6, 12, 24 and 36 months post-procedure.
Read the detailed description
The objective of this clinical investigation is to assess the safety and efficacy of the Supera Vascular Mimetic Implant for the treatment of stenotic or restenotic lesions of the common femoral artery. Furthermore, a non-inferiority hypothesis in terms of efficacy and a superiority in terms of safety will be tested with the endovascular treatment with Supera compared to surgical endarterectomy of the common femoral artery.
The patients will be selected based on the investigator's assessment, evaluation of the underlying disease and the eligibility criteria. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required testing or from completing the study. Patients should be geographically stable, willing and able to cooperate in this clinical study, and remain available for long term follow-up. The patient is considered enrolled in the study after obtaining the patients informed consent, if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion.
Prior to the index procedure the following will be collected: an informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of acute limb ischemia (Rutherford category), the resting ankle-brachial index (ABI) or toe-brachial index (TBI), blood sample test (complete blood count, comprehensive metabolic panel and if applicable pregnancy test) and a walking impairment questionnaire. Randomization will also occur prior to the procedure.
During the procedure patients that are randomized within the endarterectomy group will be treated according to the institutions standard of care. For patients that are randomized within the Supera arm, the guidewire will cross the entire study lesion after which the lesion will be assessed through angiography. Pre-dilatation of the target lesion with an uncoated PTA-balloon is mandatory and will be followed by stenting with the Supera stent according to the instructions for use. Postdilatation of the stent is allowed but not mandatory.
The regular follow-up is necessary to monitor the condition of the patient and the results of the procedure. The patients will be invited for the following required follow-up visits at 1, 6, 12, 24 and 36 months. During these visit the following data will be collected: medication record, physical exam, target limb ABI/TBI and Rutherford classification, duplex ultrasound of target vessel, walking impairment questionnaire and possible adverse events.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Supera Peripheral Stent System treatment group, Endarterectomy treatment group
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supera Peripheral Stent System treatment groupDevice
Percutaneous endovascular stenting with the Supera Peripheral Stent System
Endarterectomy treatment groupProcedure or surgery
Surgical treatment through endarterectomy
| Study group | Role | What they receive |
|---|---|---|
| Supera Peripheral Stent System treatment group | Experimental | These patients will be treated endovascularly with the Supera Peripheral Stent System (Abbott). Receives: Device: Supera Peripheral Stent System treatment group |
| Endarterectomy treatment group | Active comparator | These patients will be treated surgically with endarterectomy Receives: Procedure: Endarterectomy treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint at 12 months: Primary patency
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: freedom from 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 without a previous target lesion revascularization through 12 months post-index procedure.
Measured: 12 months post-index-procedure
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)).
Measured: 30 days post-index-procedure
Secondary outcomes (13)
Technical success: post-procedure residual stenosis <30%
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.
Measured: Index procedure
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.
Measured: 6, 12, 24 and 36 months post-index-procedure
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
Measured: 6, 24 and 36 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
Measured: 6, 12, 24 and 36 months post-index-procedure
TVR at 6-, 12-, 24- and 36-months post-index procedure
Target vessel revascularization (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
Measured: 6, 12, 24 and 36 months post-index-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
Measured: 6, 12, 24 and 36 months post-index-procedure
Duration of initial hospitalisation stay
Number of hours/days of the initial hospitalisation stay.
Measured: Up to 4 weeks
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)
Measured: 6, 12, 24 and 36 months post-index-procedure
Change in Walking Impairment Questionnaire (WIQ) score from baseline to 6, 12, 24 and 36 months
change in walking impairment questionnaire (WIQ) score from baseline to 6 and 12 months.
The WIQ consists of 6 sections each consisting of multiple questions. Each question is scored from 0 to 4 (0 meaning a lot of problems and 4 no problems at all). The scores per section are summed up and recalculated to percentages (100% meaning very good and 0% meaning very bad). All the sections are averaged to give the final WIQ-score.
Measured: 6, 12, 24 and 36 months post-index-procedure
Change in target limb Rutherford class from baseline to 6, 12, 24 and 36 months
Change in target limb Rutherford class from baseline to 6, 12, 24 and 36 months
Measured: 6, 12, 24 and 36 months post-index-procedure
Change in target limb resting ABI or TBI 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
Measured: 6, 12, 24 and 36 months post-index-procedure
All cause death at 6, 12, 24 and 36 months
All cause death at 6, 12, 24 and 36 months
Measured: 6, 12, 24 and 36 months post-index-procedure
Thrombosis at the target lesion at 6, 12, 24 and 36 months
Thrombosis at the target lesion at 6, 12, 24 and 36 months
Measured: 6, 12, 24 and 36 months post-index-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start5 May 2020
- Primary completionMay 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subjects will be randomly assigned in a 1:1 manner to treatment with either the Supera stent or endarterectomy.
- Masking
- None (open label)
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KANDO Research
- Sponsor type
- University, hospital or other
- Collaborators
- Xper Research
- Responsible party
- Sponsor
- Investigators
- Koen Deloose, MD, Principal investigator, A.Z. Sint-Blasius
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349657
- Sponsor's protocol ID
- SUPERSURG RCT-v2.0-24MAR2026
- Acronym
- SUPERSURG-RCT
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2020
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT Evaluating the Safety and Efficacy of the Endovascular Treatment of Subjects With Stenotic or Restenotic Lesions of the Common Femoral Artery With the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy
- ClinicalTrials.gov ID
- NCT04349657
- Acronym / sponsor ID
- SUPERSURG-RCT / SUPERSURG RCT-v2.0-24MAR2026
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- KANDO ResearchUniversity, hospital or other
- Collaborators
- Xper Research
- Study start
- 5 May 2020 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The SUPERSURG RCT trial investigates the efficacy and safety of the endovascular treatment of stenosis or restenosis in the common femoral artery (CFA) of patients presenting with Rutherford classification 2,3 or 4 with a Supera Vascular Mimetic Implant of Abbott, compared to classic surgical common femoral artery endarterectomy. The Supera Vascular Mimetic Implant has an interwoven design and has a high crush resistance and is, when correctly implanted, an ideal stent to treat eccentric calcified plaques in the CFA.
An expected total of 143 patients will be treated with the Vascular Mimetic Implant of Abbott and compared to a control group of another 143 patients that will be treated with classic surgical endarterectomy of the common femoral artery. Assignment to the treatment groups will be at random.
Patients will be invited for a follow-up visit at 1, 6, 12, 24 and 36 months post-procedure.
The primary efficacy endpoint is defined as follows: freedom from clinically-driven target lesion revascularization and binary restenosis at 12 months. The primary safety endpoint is defined as follows: a composite of overall death, cardiac, pulmonary, renal complications, sepsis, target lesion revascularisation and wound related complications through 30 days post-index procedure.
The secondary endpoints are defined as technical success, primary patency in the deep femoral artery, primary patency in the target lesion, target lesion revascularisation, target vessel revascularisation, binary restenosis, duration of initial hospital stay, sustained clinical improvement, change of walking impairment questionnaire score from baseline, change in target limb Rutherford classification, change in target limb ABI/TBI from baseline, all cause death, thrombosis at the target lesion through 6, 12, 24 and 36 months post-procedure.
Detailed description
The objective of this clinical investigation is to assess the safety and efficacy of the Supera Vascular Mimetic Implant for the treatment of stenotic or restenotic lesions of the common femoral artery. Furthermore, a non-inferiority hypothesis in terms of efficacy and a superiority in terms of safety will be tested with the endovascular treatment with Supera compared to surgical endarterectomy of the common femoral artery.
The patients will be selected based on the investigator's assessment, evaluation of the underlying disease and the eligibility criteria. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required testing or from completing the study. Patients should be geographically stable, willing and able to cooperate in this clinical study, and remain available for long term follow-up. The patient is considered enrolled in the study after obtaining the patients informed consent, if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion.
Prior to the index procedure the following will be collected: an informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of acute limb ischemia (Rutherford category), the resting ankle-brachial index (ABI) or toe-brachial index (TBI), blood sample test (complete blood count, comprehensive metabolic panel and if applicable pregnancy test) and a walking impairment questionnaire. Randomization will also occur prior to the procedure.
During the procedure patients that are randomized within the endarterectomy group will be treated according to the institutions standard of care. For patients that are randomized within the Supera arm, the guidewire will cross the entire study lesion after which the lesion will be assessed through angiography. Pre-dilatation of the target lesion with an uncoated PTA-balloon is mandatory and will be followed by stenting with the Supera stent according to the instructions for use. Postdilatation of the stent is allowed but not mandatory.
The regular follow-up is necessary to monitor the condition of the patient and the results of the procedure. The patients will be invited for the following required follow-up visits at 1, 6, 12, 24 and 36 months. During these visit the following data will be collected: medication record, physical exam, target limb ABI/TBI and Rutherford classification, duplex ultrasound of target vessel, walking impairment questionnaire and possible adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The subjects will be randomly assigned in a 1:1 manner to treatment with either the Supera stent or endarterectomy.
| Arm | Type | Receives |
|---|---|---|
| Supera Peripheral Stent System treatment group | Experimental | Device: Supera Peripheral Stent System treatment groupThese patients will be treated endovascularly with the Supera Peripheral Stent System (Abbott). |
| Endarterectomy treatment group | Active comparator | Procedure: Endarterectomy treatment groupThese patients will be treated surgically with endarterectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is ≥18 years old
- Patient presenting a score from 2 to 4 following Rutherford classification
- Patient is willing to comply with specified follow-up evaluations at the specified times
- Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- Patient has a life expectancy of at least 12 months
Key exclusion criteria (18 listed)
- Presence of another stent in the target vessel that was placed during a previous procedure
- Previous open surgery in the ipsilateral groin
- Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
- Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supera Peripheral Stent System treatment groupPercutaneous endovascular stenting with the Supera Peripheral Stent System | Device | Supera Peripheral Stent System treatment group |
| Endarterectomy treatment groupSurgical treatment through endarterectomy | Procedure or surgery | Endarterectomy treatment group |
Primary outcome
Primary efficacy endpoint at 12 months: Primary patency
Time frame: 12 months post-index-procedure
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: freedom from 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 without a previous target lesion revascularization through 12 months post-index procedure.
Primary safety endpoint at 30 days post-index procedure
Time frame: 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)).
13 secondary outcomes
Technical success: post-procedure residual stenosis <30%
Time frame: Index procedure
Primary patency in the deep femoral artery (DFA), post-index procedure and at 6-, 12-, 24- and 36-months post-index procedure
Time frame: 6, 12, 24 and 36 months post-index-procedure
Primary patency at 6, 24 and 36 months
Time frame: 6, 24 and 36 months post-index-procedure
TLR at 6-, 12-, 24- and 36-months post-index procedure
Time frame: 6, 12, 24 and 36 months post-index-procedure
TVR at 6-, 12-, 24- and 36-months post-index procedure
Time frame: 6, 12, 24 and 36 months post-index-procedure
Binary restenosis at 6, 12, 24 and 36 months
Time frame: 6, 12, 24 and 36 months post-index-procedure
Duration of initial hospitalisation stay
Time frame: Up to 4 weeks
Sustained clinical improvement at 6-, 12-, 24- and 36-months post-index procedure
Time frame: 6, 12, 24 and 36 months post-index-procedure
Change in Walking Impairment Questionnaire (WIQ) score from baseline to 6, 12, 24 and 36 months
Time frame: 6, 12, 24 and 36 months post-index-procedure
Change in target limb Rutherford class from baseline to 6, 12, 24 and 36 months
Time frame: 6, 12, 24 and 36 months post-index-procedure
Change in target limb resting ABI or TBI from baseline to 6, 12, 24 and 36 months
Time frame: 6, 12, 24 and 36 months post-index-procedure
All cause death at 6, 12, 24 and 36 months
Time frame: 6, 12, 24 and 36 months post-index-procedure
Thrombosis at the target lesion at 6, 12, 24 and 36 months
Time frame: 6, 12, 24 and 36 months post-index-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koen Deloose, MD principal investigator
A.Z. Sint-Blasius
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supera Peripheral Stent System treatment group and Endarterectomy treatment group in people with Peripheral Arterial Disease, run by KANDO Research at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Belgium, Netherlands, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoint at 12 months: Primary patency (time frame: 12 months post-index-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.