Clinical trial NCT03941314: A Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease
Official title: A Prospective Randomized, Parallel-group, Multicentre, Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
Collaborators: name: Abbott
name: Cantonal Hospital of St. Gallen
First posted: 2019-05-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in primary patency rate (proportion of patients classed as treatment succsess)
timeFrame: 24 months
Secondary outcomes:
measure: Difference in primary patency rate
timeFrame: 1 month, 6 months, 12 months
measure: Difference in target lesion/vessel revascularization
timeFrame: 24 months
measure: Difference in amputation
timeFrame: 24 months
measure: Difference in time to restenosis (and time to target lesion revascularization due to restenosis)
timeFrame: 24 months
measure: Difference in Anklre Brachial Index
timeFrame: 1 month, 6 months, 12 months, 24 months
measure: Difference in Fontaine classification
timeFrame: 1 month, 6 months, 12 months, 24 months
Other outcomes:
measure: Rate of site complications [Safety Endpoint]
timeFrame: 1 month
measure: Rate of prolonged hospital stay [Safety Endpoint]
timeFrame: 1 month
measure: Rate of need for surgical revision [Safety Endpoint]
timeFrame: 1 month
Locations:
city: Málaga
country: Spain
facility: Hospital Carlos Haya
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
Study officials:
affiliation: Kantonsspital Winterthur KSW
name: Christoph A Binkert, MD
role: PRINCIPAL_INVESTIGATOR
References: