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

Primary Purpose

Peripheral Arterial Disease

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Supera® Peripheral Stent System
EverFlex™ Self-Expanding Peripheral Stent System
Sponsored by
Kantonsspital Winterthur KSW
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Carlos Haya
  • Kantonsspital St. Gallen
  • Kantonsspital WinterthurRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Supera® Peripheral Stent System

EverFlex™ Self-Expanding Peripheral Stent System

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

Difference in primary patency rate
Peak systolic velocity ratio assessed with Duplex ultrasound
Difference in target lesion/vessel revascularization
Patients with target lesion revascularization due to restenosis or target vessel revascularization.
Difference in amputation
Proportion of patients with amputation (minor or major)
Difference in time to restenosis (and time to target lesion revascularization due to restenosis)
Difference in Anklre Brachial Index
Ankle Brachial Index of the treated lesion
Difference in Fontaine classification
Fontaine classification

Full Information

First Posted
May 2, 2019
Last Updated
August 19, 2022
Sponsor
Kantonsspital Winterthur KSW
Collaborators
Abbott, Cantonal Hospital of St. Gallen
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1. Study Identification

Unique Protocol Identification Number
NCT03941314
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kantonsspital Winterthur KSW
Collaborators
Abbott, Cantonal Hospital of St. Gallen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supera® Peripheral Stent System
Arm Type
Experimental
Arm Description
Femoro-popliteal arterial stenting with Supera® Peripheral Stent System as CE-marked by the manufacturer Abbott
Arm Title
EverFlex™ Self-Expanding Peripheral Stent System
Arm Type
Active Comparator
Arm Description
Femoro-popliteal arterial stenting with EverFlex™ Self-Expanding Peripheral Stent System with Entrust™ Delivery System or as Protégé™ EverFlex™
Intervention Type
Device
Intervention Name(s)
Supera® Peripheral Stent System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
EverFlex™ Self-Expanding Peripheral Stent System
Other Intervention Name(s)
EverFlex™ with Entrust™ Delivery System or Protégé™ EverFlex™
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in primary patency rate (proportion of patients classed as treatment succsess)
Description
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.)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Difference in primary patency rate
Description
Peak systolic velocity ratio assessed with Duplex ultrasound
Time Frame
1 month, 6 months, 12 months
Title
Difference in target lesion/vessel revascularization
Description
Patients with target lesion revascularization due to restenosis or target vessel revascularization.
Time Frame
24 months
Title
Difference in amputation
Description
Proportion of patients with amputation (minor or major)
Time Frame
24 months
Title
Difference in time to restenosis (and time to target lesion revascularization due to restenosis)
Time Frame
24 months
Title
Difference in Anklre Brachial Index
Description
Ankle Brachial Index of the treated lesion
Time Frame
1 month, 6 months, 12 months, 24 months
Title
Difference in Fontaine classification
Description
Fontaine classification
Time Frame
1 month, 6 months, 12 months, 24 months
Other Pre-specified Outcome Measures:
Title
Rate of site complications [Safety Endpoint]
Time Frame
1 month
Title
Rate of prolonged hospital stay [Safety Endpoint]
Time Frame
1 month
Title
Rate of need for surgical revision [Safety Endpoint]
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph A Binkert, MD
Phone
+41 52 266 2602
Email
christoph.binkert@ksw.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Marlene Wegmann Oswald, PhD
Phone
+41 52 266 2329
Email
marlene.wegmann@ksw.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph A Binkert, MD
Organizational Affiliation
Kantonsspital Winterthur KSW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Carlos Haya
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Joaquin Muñoz Ruiz-Canela, MD
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukas Hechelhammer, MD
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
CH-8401
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph A Binkert, MD

12. IPD Sharing Statement

Learn more about this trial

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

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