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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01500070
Registration number
NCT01500070
Ethics application status
Date submitted
19/12/2011
Date registered
26/12/2011
Date last updated
11/08/2016
Titles & IDs
Public title
PREVENT: Promus BTK
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Scientific title
PREVENT: a Prospective, Multi-center, Monitored Trial Investigating the Implant of the Promus Everolimus-Eluting Stent System in Critically Ischemic Lesions BTK
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Secondary ID [1]
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FMRP-101020
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Universal Trial Number (UTN)
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Trial acronym
PREVENT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Everolimus-Eluting Stent (PROMUS ELEMENT)
Experimental: Drug-eluting stent - Patients implanted with the PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) or the PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific).
Treatment: Devices: Everolimus-Eluting Stent (PROMUS ELEMENT)
PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) or PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific).
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary patency
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Assessment method [1]
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Absence of restenosis (50% stenosis) or occlusion within the originally treated lesion based on angiography.
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Technical success
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Assessment method [1]
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The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.
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Timepoint [1]
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1 day post-procedure
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Secondary outcome [2]
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Hemodynamic primary patency rate
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Assessment method [2]
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Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the given follow-up.
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Timepoint [2]
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1, 6 and 12 month follow-up
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Secondary outcome [3]
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Limb-salvage
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Assessment method [3]
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Absence of major amputation, defined as amputation at or above the ankle, as opposed to minor amputation, being an amputation at or below metatarsal level, preserving functionality of the foot).
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Timepoint [3]
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1, 6 and 12 month follow-up
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Secondary outcome [4]
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Primary assisted patency rate
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Assessment method [4]
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Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure.
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Timepoint [4]
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1, 6 and 12 month follow-up
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Secondary outcome [5]
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Secondary patency rate
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Assessment method [5]
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Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion.
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Timepoint [5]
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1, 6 and 12 month follow-up
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Secondary outcome [6]
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Target lesion revascularization (TLR)
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Assessment method [6]
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Defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge.
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Timepoint [6]
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1 day, 1 month, 6 month and 12 month follow-up
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Secondary outcome [7]
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Clinical success at follow-up
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Assessment method [7]
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Defined as an improvement of Rutherford classification at 1 day and 1, 6, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
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Timepoint [7]
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1 day, 1 month, 6 month and 12 month follow-up
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Secondary outcome [8]
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Improvement of ankle-brachial index (ABI)
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Assessment method [8]
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Defined as an increase of the ABI at 1 day and 1, 6, 12-month follow-up compared to baseline in subjects with compressible arteries and baseline ABI <0.9.
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Timepoint [8]
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1 day, 1 month, 6 month and 12 month follow-up
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Secondary outcome [9]
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Serious Adverse Events (SAE)
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Assessment method [9]
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Defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
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Timepoint [9]
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1 day, 1 month, 6 month and 12 month follow-up
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Eligibility
Key inclusion criteria
General
- Patient presenting with rest pain or minor tissue loss (Rutherford class 4 or 5)
- Patient is willing to comply with specified follow-up evaluations at the specified
times
- Patient is >18 years old
- Patient understands the nature of the procedure and provides written informed consent,
prior to enrolment in the study
- Patient has a projected life-expectancy of at least 12 months
- The treating physician consider the patient eligible for below-the-knee treatment with
the PROMUS ELEMENT Stent (Boston Scientific) and PROMUS ELEMENT PLUS Stent (Boston
Scientific)
- Male, infertile female, or female of child bearing potential practicing an acceptable
method of birth control with a negative pregnancy test within 7 days prior to study
procedure
Angiographic
- Single or multiple lesions with minimally 70% stenosis in one or more infrapopliteal
arteries, including the tibiofibular trunk
- A maximum of two focal target lesions in one or more infrapopliteal vessels
- Length of lesion is maximally 40 mm, allowing maximally 2 planned stents to be
implanted
- Target vessel diameter visually estimated to be >2.5mm and <4.0mm
- Guidewire and delivery system successfully traversed lesion
General
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patient refusing treatment
- Previously implanted stent in the artery to be treated
- Failed PTA of target lesion/vessel less than 3 months prior to study procedure
- The reference segment diameter is not suitable for the available stent design
- Untreated flow-limiting inflow lesions
- Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow
disease just prior to enrollment
- Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
- Aneurysm in the target vessel
- Patient presents with renal failure, evidenced by a serum creatinine level >2.0mg/dL
- Patient presents with platelet levels above or below normal range
- Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease,
vasculitis)
- Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy,
dementia, etc) or other medical condition that would preclude compliance with the
study protocol or 1-year life expectancy
- Major distal amputation (above the transmetatarsal) in the study limb or non-study
limb
- Septicemia or bacteremia
- Any previously known coagulation disorder, including hypercoagulability
- Contraindication to anticoagulation or antiplatelet therapy
- Known allergies to stent or stent components
- Known allergy to contrast media that cannot be adequately pre-medicated prior to the
study procedure
- Patient with known hypersensitivity to heparin, including those patients who have had
a previous incidence of heparin-induced thrombocytopenia (HIT) type II
- Currently participating in another clinical research trial
- Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow
treatment
- Target lesion access not performed by transfemoral approach.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2016
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Sample size
Target
70
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Antwerpen
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Country [2]
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Belgium
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State/province [2]
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Oost-Vlaanderen
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Country [3]
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Belgium
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State/province [3]
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Tienen
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Country [4]
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Germany
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State/province [4]
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Freistaat Sachsen
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Country [5]
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Germany
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State/province [5]
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Land Baden-Württemberg
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Country [6]
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Germany
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State/province [6]
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Nordrhein-Westfalen
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Country [7]
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New Zealand
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State/province [7]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
Flanders Medical Research Program
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a single-arm, prospective, multi-center monitored trial recruiting patients with
critical limb ischemia and with one or more lesions in the arteries below the knee. The
immediate and long-term (up to 12 months) outcome of the PROMUS ELEMENT Everolimus-Eluting
Stent System (Boston Scientific) and the PROMUS ELEMENT PLUS Everolimus-Eluting Stent System
(Boston Scientific) will be evaluated.
In 2 Belgian centers, 3 German centers and 1 New Zealand center a total of 70 patients will
be recruited. Primary endpoint is primary patency at 12 months, defined as absence of
restenosis (=50% stenosis) or occlusion within the originally treated lesion based on
angiography.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01500070
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Marc Bosiers, MD
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Address
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AZ Sint Blasius, Dendermonde, Belgium
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01500070
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