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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
PREVENT: a Prospective, Multi-center, Monitored Trial Investigating the Implant of the Promus Everolimus-Eluting Stent System in Critically Ischemic Lesions BTK
Secondary ID [1] 0 0
FMRP-101020
Universal Trial Number (UTN)
Trial acronym
PREVENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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).

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary patency - Absence of restenosis (50% stenosis) or occlusion within the originally treated lesion based on angiography.
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Technical success - The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.
Timepoint [1] 0 0
1 day post-procedure
Secondary outcome [2] 0 0
Hemodynamic primary patency rate - 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.
Timepoint [2] 0 0
1, 6 and 12 month follow-up
Secondary outcome [3] 0 0
Limb-salvage - 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).
Timepoint [3] 0 0
1, 6 and 12 month follow-up
Secondary outcome [4] 0 0
Primary assisted patency rate - Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure.
Timepoint [4] 0 0
1, 6 and 12 month follow-up
Secondary outcome [5] 0 0
Secondary patency rate - Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion.
Timepoint [5] 0 0
1, 6 and 12 month follow-up
Secondary outcome [6] 0 0
Target lesion revascularization (TLR) - 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.
Timepoint [6] 0 0
1 day, 1 month, 6 month and 12 month follow-up
Secondary outcome [7] 0 0
Clinical success at follow-up - 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.
Timepoint [7] 0 0
1 day, 1 month, 6 month and 12 month follow-up
Secondary outcome [8] 0 0
Improvement of ankle-brachial index (ABI) - 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.
Timepoint [8] 0 0
1 day, 1 month, 6 month and 12 month follow-up
Secondary outcome [9] 0 0
Serious Adverse Events (SAE) - 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.
Timepoint [9] 0 0
1 day, 1 month, 6 month and 12 month follow-up

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
Belgium
State/province [2] 0 0
Oost-Vlaanderen
Country [3] 0 0
Belgium
State/province [3] 0 0
Tienen
Country [4] 0 0
Germany
State/province [4] 0 0
Freistaat Sachsen
Country [5] 0 0
Germany
State/province [5] 0 0
Land Baden-Württemberg
Country [6] 0 0
Germany
State/province [6] 0 0
Nordrhein-Westfalen
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Flanders Medical Research Program
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01500070
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marc Bosiers, MD
Address 0 0
AZ Sint Blasius, Dendermonde, Belgium
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications