A Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease

NCT03941314 | Active Not Recruiting

• 2 other identifiers: BASEC 2019-00312CTU 17/037
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 3

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Difference in primary patency rate (proportion of patients classed as treatment succsess)

  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.)

  24 months

Secondary Outcomes (6)

• Difference in primary patency rate

  1 month, 6 months, 12 months

• Difference in target lesion/vessel revascularization

  24 months

• Difference in amputation

  24 months

• 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

Other Outcomes (3)

• Rate of site complications [Safety Endpoint]

  1 month

• Rate of prolonged hospital stay [Safety Endpoint]

  1 month

• Rate of need for surgical revision [Safety Endpoint]

  1 month

Study Arms (2)

Supera® Peripheral Stent System

EXPERIMENTAL

Femoro-popliteal arterial stenting with Supera® Peripheral Stent System as CE-marked by the manufacturer Abbott

Device: Supera® Peripheral Stent System

EverFlex™ Self-Expanding Peripheral Stent System

ACTIVE COMPARATOR

Femoro-popliteal arterial stenting with EverFlex™ Self-Expanding Peripheral Stent System with Entrust™ Delivery System or as Protégé™ EverFlex™

Device: EverFlex™ Self-Expanding Peripheral Stent System

Interventions

Supera® Peripheral Stent System DEVICE

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.

Supera® Peripheral Stent System

EverFlex™ Self-Expanding Peripheral Stent System DEVICE

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.

Also known as: EverFlex™ with Entrust™ Delivery System or Protégé™ EverFlex™

EverFlex™ Self-Expanding Peripheral Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kantonsspital Winterthur KSW: lead
• Abbott: collaborator
• Cantonal Hospital of St. Gallen: collaborator

Study Sites (3)

Hospital Carlos Haya

Málaga, 29010, Spain

Location

Kantonsspital St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Kantonsspital Winterthur

Winterthur, CH-8401, Switzerland

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Christoph A Binkert, MD

  Kantonsspital Winterthur KSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 7, 2019
• Study Start: June 25, 2019
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

ES (1); CH (2)