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出境医 / 临床实验 / A Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease
A Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease
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.
| 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
| 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
| 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.
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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
Primary Outcome Measures :
- 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 :
- Difference in primary patency rate [ Time Frame: 1 month, 6 months, 12 months ]Peak systolic velocity ratio assessed with Duplex ultrasound
- Difference in target lesion/vessel revascularization [ Time Frame: 24 months ]Patients with target lesion revascularization due to restenosis or target vessel revascularization.
- Difference in amputation [ Time Frame: 24 months ]Proportion of patients with amputation (minor or major)
- Difference in time to restenosis (and time to target lesion revascularization due to restenosis) [ Time Frame: 24 months ]
- Difference in Anklre Brachial Index [ Time Frame: 1 month, 6 months, 12 months, 24 months ]Ankle Brachial Index of the treated lesion
- Difference in Fontaine classification [ Time Frame: 1 month, 6 months, 12 months, 24 months ]Fontaine classification
Other Outcome Measures:
- Rate of site complications [Safety Endpoint] [ Time Frame: 1 month ]
- Rate of prolonged hospital stay [Safety Endpoint] [ Time Frame: 1 month ]
- Rate of need for surgical revision [Safety Endpoint] [ Time Frame: 1 month ]
Eligibility Criteria
| 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
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
| 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
| Principal Investigator: | Christoph A Binkert, MD | Kantonsspital Winterthur KSW |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 2, 2019 | ||||||||
| First Posted Date ICMJE | May 7, 2019 | ||||||||
| Last Update Posted Date | September 1, 2020 | ||||||||
| Actual Study Start Date ICMJE | June 25, 2019 | ||||||||
| Estimated Primary Completion Date | May 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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.)
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease | ||||||||
| Official Title ICMJE | A Prospective Randomized, Parallel-group, Multicentre, Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Peripheral Arterial Disease | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
300 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | May 2023 | ||||||||
| Estimated Primary Completion Date | May 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Spain, Switzerland | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03941314 | ||||||||
| Other Study ID Numbers ICMJE | BASEC 2019-00312 CTU 17/037 ( Other Identifier: CTU Kantonsspital St. Gallen ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Kantonsspital Winterthur KSW | ||||||||
| Study Sponsor ICMJE | Kantonsspital Winterthur KSW | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Kantonsspital Winterthur KSW | ||||||||
| Verification Date | August 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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