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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03321552




Registration number
NCT03321552
Ethics application status
Date submitted
30/08/2017
Date registered
25/10/2017

Titles & IDs
Public title
PROMISE International
Scientific title
Percutaneous Deep Vein Arterialization Post-Market Study
Secondary ID [1] 0 0
EU PMS Revision 4.1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Limb Ischemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Percutaneous deep vein arterialization
Treatment: Devices - LimFlow System

Experimental: Percutaneous deep vein arterialization - Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach


Treatment: Surgery: Percutaneous deep vein arterialization
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach

Treatment: Devices: LimFlow System
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Amputation-free survival
Timepoint [1] 0 0
Throughout one year
Secondary outcome [1] 0 0
Wound healing
Timepoint [1] 0 0
Throughout one year
Secondary outcome [2] 0 0
Primary and secondary patency as assessed by duplex ultrasound
Timepoint [2] 0 0
Throughout one year
Secondary outcome [3] 0 0
Limb salvage: Freedom from major amputation
Timepoint [3] 0 0
Throughout one year
Secondary outcome [4] 0 0
Deterioration in renal function as assessed by creatinine level
Timepoint [4] 0 0
One month and six months
Secondary outcome [5] 0 0
Technical success (procedure completion)
Timepoint [5] 0 0
Immediately post-procedure
Secondary outcome [6] 0 0
Procedural success (technical success without death, major amputation, or re-intervention)
Timepoint [6] 0 0
One month post-procedure

Eligibility
Key inclusion criteria
* Subject must be > 21 and < 95 years of age
* Clinical diagnosis of symptomatic critical limb ischemia, defined as Rutherford category 5 or 6
* Assessment that no conventional surgical or endovascular treatment is possible
* Proximally, the target in-flow artery at the cross-over point must be treatable with a 3.5 - 4.0 mm stent after pre-treatment (by visual estimate), and be <50% stenosed
* Subject is willing and has adequate support to comply with protocol requirements, including medication regimen and follow-up visits
Minimum age
21 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Concomitant hepatic insufficiency, deep venous thrombus in target limb, uncorrected coagulation disorders, or current immunodeficiency disorder
* Prior vein stripping surgery and/or vessel harvesting for CABG in the limb intended for study
* Life expectancy less than 12 months
* Patient currently taking coumarin/warfarin which, in the opinion of the attending physician, interferes with the patient's treatment
* Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal treatment
* Patient currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this treatment
* Patient unable to give consent
* Pregnant or breastfeeding women
* Documented myocardial infarction or stroke within previous 90 days
* Patients suffering from renal insufficiency (GFR value less than 30 ml/min/1.73 m²) who are not on hemodialysis
* Patients with vasculitis and/or untreated popliteal aneurysms
* Patients with acute limb ischemia
* Prior peripheral arterial bypass procedure above or below the knee which could inhibit proximal inflow to the stent graft
* Lower extremity venous disease with significant edema in the target limb that may inhibit the procedure and/or jeopardize wound healing, in the investigator's opinion
* Known or suspected systemic or severe infection (e.g., WIfI foot Infection grade of 3)
* Known or suspected allergies or contraindications to stainless steel, nickel, or contrast agent that cannot be adequately pre-treated, or patients who cannot receive anticoagulation or antiplatelet aggregation therapy
* Severe heart failure, which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure (e.g., known ejection fraction of < 40%, NYHA Classification III-IV)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/01/2025
Actual
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Germany
State/province [2] 0 0
Baden-Württemberg
Country [3] 0 0
Germany
State/province [3] 0 0
North Rhine-Westphalia
Country [4] 0 0
Germany
State/province [4] 0 0
Saxony
Country [5] 0 0
Netherlands
State/province [5] 0 0
's-Hertogenbosch
Country [6] 0 0
Netherlands
State/province [6] 0 0
Alkmaar
Country [7] 0 0
Netherlands
State/province [7] 0 0
Nieuwegein
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
Singapore
State/province [9] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
LimFlow SA
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Undecided


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/NCT03321552