Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03941314
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : September 1, 2020
Sponsor:
Collaborators:
Abbott
Cantonal Hospital of St. Gallen
Information provided by (Responsible Party):
Kantonsspital Winterthur KSW

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Supera® Peripheral Stent System Device: EverFlex™ Self-Expanding Peripheral Stent System Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized, Parallel-group, Multicentre, Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Supera® Peripheral Stent System
Femoro-popliteal arterial stenting with Supera® Peripheral Stent System as CE-marked by the manufacturer Abbott
 Device: Supera® 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.
Active Comparator: EverFlex™ Self-Expanding Peripheral Stent System
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
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.
Other Name: EverFlex™ with Entrust™ Delivery System or Protégé™ EverFlex™


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Difference in primary patency rate (proportion of patients classed as treatment succsess) [ Time Frame: 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 Outcome Measures :
  1. Difference in primary patency rate [ Time Frame: 1 month, 6 months, 12 months ]
    Peak systolic velocity ratio assessed with Duplex ultrasound

  2. Difference in target lesion/vessel revascularization [ Time Frame: 24 months ]
    Patients with target lesion revascularization due to restenosis or target vessel revascularization.

  3. Difference in amputation [ Time Frame: 24 months ]
    Proportion of patients with amputation (minor or major)

  4. Difference in time to restenosis (and time to target lesion revascularization due to restenosis) [ Time Frame: 24 months ]
  5. Difference in Anklre Brachial Index [ Time Frame: 1 month, 6 months, 12 months, 24 months ]
    Ankle Brachial Index of the treated lesion

  6. Difference in Fontaine classification [ Time Frame: 1 month, 6 months, 12 months, 24 months ]
    Fontaine classification


Other Outcome Measures:
  1. Rate of site complications [Safety Endpoint] [ Time Frame: 1 month ]
  2. Rate of prolonged hospital stay [Safety Endpoint] [ Time Frame: 1 month ]
  3. Rate of need for surgical revision [Safety Endpoint] [ Time Frame: 1 month ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941314


Contacts
Layout table for location contacts
Contact: Christoph A Binkert, MD +41 52 266 2602 christoph.binkert@ksw.ch
Contact: Marlene Wegmann Oswald, PhD +41 52 266 2329 marlene.wegmann@ksw.ch

Locations
Layout table for location information
Spain
Hospital Carlos Haya Not yet recruiting
Málaga, Spain, 29010
Contact: José Joaquin Muñoz Ruiz-Canela, MD         
Switzerland
Kantonsspital St. Gallen Not yet recruiting
St. Gallen, Switzerland, CH-9007
Contact: Lukas Hechelhammer, MD         
Kantonsspital Winterthur Recruiting
Winterthur, Switzerland, CH-8401
Contact: Christoph A Binkert, MD         
Sponsors and Collaborators
Kantonsspital Winterthur KSW
Abbott
Cantonal Hospital of St. Gallen
Investigators
Layout table for investigator information
Principal Investigator: Christoph A Binkert, MD Kantonsspital Winterthur KSW
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier: NCT03941314    
Other Study ID Numbers: BASEC 2019-00312
CTU 17/037 ( Other Identifier: CTU Kantonsspital St. Gallen )
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases