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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Technical success
Timepoint [1] 0 0
1 day post-procedure
Secondary outcome [2] 0 0
Hemodynamic primary patency rate
Timepoint [2] 0 0
1, 6 and 12 month follow-up
Secondary outcome [3] 0 0
Limb-salvage
Timepoint [3] 0 0
1, 6 and 12 month follow-up
Secondary outcome [4] 0 0
Primary assisted patency rate
Timepoint [4] 0 0
1, 6 and 12 month follow-up
Secondary outcome [5] 0 0
Secondary patency rate
Timepoint [5] 0 0
1, 6 and 12 month follow-up
Secondary outcome [6] 0 0
Target lesion revascularization (TLR)
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
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)
Timepoint [8] 0 0
1 day, 1 month, 6 month and 12 month follow-up
Secondary outcome [9] 0 0
Serious Adverse Events (SAE)
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
Sex
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
NA
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
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2016
Sample size
Target
70
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01500070