Supera Stent Study in Patients with Narrowing of the Leg Arteries
Summary description of the study
This study investigates two different stents (vascular wall support) for the treatment of circulatory disorders caused by narrowing of the leg arteries. We compare whether the Supera® stent from the manufacturer Abbott is superior to the standard stent from the manufacturer Medtronic, the EverFlex™, in terms of primary patency rate and the need for re-intervention within 24 months. As part of the regular treatment, an angiography (vascular imaging with contrast agent) and balloon dilation (expansion of the narrowing) are performed. If this is sufficient to keep the leg arteries open and no stent is needed, the patient cannot participate in the study. Otherwise, the stent placement occurs, provided the patient continues to meet all study eligibility requirements. The stent placement procedure is carried out according to medical regulations, as well as outside the study. After stent placement, patients rest in bed for approximately 2-4 hours and can generally go home the same day or the following day, provided their health status is checked beforehand. Thereafter, patients must come to the treating hospital for examinations at months 1, 6, 12, and 24 to check their health status and response to therapy. For this purpose, physical and imaging examinations, such as ultrasound and pressure measurements (pulse status), are performed. The total study duration per patient is 24 months. This study is conducted as a prospective, randomized, multicenter parallel-group study. This means that a random process decides, comparable to flipping a coin, whether a patient receives the Supera® stent or an EverFlex™ stent; this is called randomization. The probability of receiving the Supera® stent is 50%. Both stents used in this study, Supera® or EverFlex™, are approved medical devices that are used in the same way as they are already used in everyday clinical practice.
(BASEC)
Intervention under investigation
Stents (vascular wall support) for the treatment of circulatory disorders caused by narrowing/occlusion of the leg arteries.
Stents used in this study: Supera® stent from the manufacturer Abbott or EverFlex™ Entrust™ or Protégé™ EverFlex™ from the manufacturer Medtronic
(BASEC)
Disease under investigation
Circulatory disorders caused by narrowing/occlusion of the leg arteries
(BASEC)
- Patients with femoro-popliteal artery disease requiring a stent after balloon dilation - Available for 24 months - Men and women aged 18 years and older (BASEC)
Exclusion criteria
- Patients who cannot receive combined antiplatelet therapy (Aspirin 100 mg and Clopidogrel 75 mg) or anticoagulation therapy - Patients with known allergies to Nitinol (Nickel-Titanium) or contrast agents that cannot be medically treated - Previous stent implantation in the intended vascular segment (BASEC)
Trial sites
St. Gallen, Winterthur
(BASEC)
Sponsor
Kantonsspital Winterthur
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Christoph A. Binkert
+41 52 266 21 21
christoph.binkert@clutterksw.chKantonsspital Winterthur
(BASEC)
General Information
Kantonsspital Winterthur KSW
(ICTRP)
Scientific Information
Kantonsspital Winterthur KSW
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
18.04.2019
(BASEC)
ICTRP Trial ID
NCT03941314 (ICTRP)
Official title (approved by ethics committee)
A prospective randomized, parallel-group, multicentre, superiority trial of the SUPERA peripheral stent system in patients with femoro-popliteal artery disease (BASEC)
Academic title
A Prospective Randomized, Parallel-group, Multicentre, Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease (ICTRP)
Public title
A Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease (ICTRP)
Disease under investigation
Peripheral Arterial Disease (ICTRP)
Intervention under investigation
Device: Supera? Peripheral Stent System;Device: EverFlex? Self-Expanding Peripheral Stent System (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Patients with femoro-popliteal artery disease, who will require a stent
femoro-popliteal following failed percutaneous transluminal angioplasty (PTA)
- Target Lesion length <200mm
- Planned follow-up available for at least 24 months
- Written informed consent to participate in the study and agreement to comply with the
study protocol must be obtained from the patient prior to initiation of any
study-mandated procedure and randomization
Exclusion Criteria:
- Life expectancy <24 months
- Patients who cannot receive dual antiplatelet therapy (aspirin 100mg and clopidogrel
75mg) or anticoagulation therapy
- Patients with known allergies to: nitinol (nickel titanium); or contrast agent, that
cannot be medically managed
- Participation in another study with investigational drug/device within the 30 days
preceding and during the present study
- Previous enrolment into the current study
- Prior stenting at the location of intended stenting
- Patients who are judged to have a lesion that prevents complete inflation of an
angioplasty balloon or proper placement of the stent or stent delivery system
- Enrolment of study investigator, his/her family members, employees and other dependent
persons
- If female and of childbearing potential: known pregnancy or a positive urine pregnancy
test (confirmed by a positive serum pregnancy test), or lactating
(ICTRP)
not available
Primary and secondary end points
Difference in primary patency rate (proportion of patients classed as treatment succsess) (ICTRP)
Difference in primary patency rate;Difference in target lesion/vessel revascularization;Difference in amputation;Difference in time to restenosis (and time to target lesion revascularization due to restenosis);Difference in Anklre Brachial Index;Difference in Fontaine classification (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
Abbott;Cantonal Hospital of St. Gallen (ICTRP)
Additional contacts
Christoph A Binkert, MD, Kantonsspital Winterthur KSW (ICTRP)
Secondary trial IDs
CTU 17/037, BASEC 2019-00312 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT03941314 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available