Peripheral Arterial Disease
Conditions
Brief summary
The purpose of this study (superiority trial) is to compare the Supera® Peripheral Stent System with a standard nitinol self-expanding stent for treatment of femoro-popliteal arterial occlusive disease. Hypothesis: The Supera® stent is superior to a standard nitinol self-expanding stent, for treatment of femoro-popliteal artery disease in terms of (1) primary patency rate and (2) need for revascularization up to 24 months after stent insertion.
Interventions
DEVICESupera® Peripheral Stent System
The index procedure is placing a selfexpandable stent at a femoro-popliteal location. The way the stenosis or occlusion is traversed is not part of the study. It is mandatory to prepare then the vessel with PTA (at least the size of the stent) and thereafter insert the stent. Post-PTA can be performed with same balloon, but post-PTA is not mandatory to be performed.
The index procedure is placing a selfexpandable stent at a femoro-popliteal location. The way the stenosis or occlusion is traversed is not part of the study. It is mandatory to prepare then the vessel with PTA (at least the size of the stent) and thereafter insert the stent. Post-PTA can be performed with same balloon, but post-PTA is not mandatory to be performed.
Sponsors
Kantonsspital Winterthur KSW
Abbott
Cantonal Hospital of St. Gallen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in primary patency rate (proportion of patients classed as treatment succsess) | 24 months | Peak systolic velocity ratio assessed with Duplex ultrasound (Treatment success is defined as Peak Systolic Velocity (PSV) ratio \< 2.5 at the stented target lesion measured by Duplex ultrasound (DUS) indicating freedom from \>50% restenosis with no clinically driven re-intervention within the stented segment.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in primary patency rate | 1 month, 6 months, 12 months | Peak systolic velocity ratio assessed with Duplex ultrasound |
| Difference in target lesion/vessel revascularization | 24 months | Patients with target lesion revascularization due to restenosis or target vessel revascularization. |
| Difference in amputation | 24 months | Proportion of patients with amputation (minor or major) |
| Difference in time to restenosis (and time to target lesion revascularization due to restenosis) | 24 months | — |
| Difference in Anklre Brachial Index | 1 month, 6 months, 12 months, 24 months | Ankle Brachial Index of the treated lesion |
| Difference in Fontaine classification | 1 month, 6 months, 12 months, 24 months | Fontaine classification |
Countries
Spain, Switzerland
Contacts
PRINCIPAL_INVESTIGATORChristoph A Binkert, MD
Kantonsspital Winterthur KSW
Outcome results
None listed