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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/NCT03547986
Registration number
NCT03547986
Ethics application status
Date submitted
18/05/2018
Date registered
6/06/2018
Date last updated
29/08/2022
Titles & IDs
Public title
BIO REsponse Adapted Combination Therapy Pilot Study
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Scientific title
Evaluation of Adjunctive Procedural Assessments to Diagnose Post Drug-coated Balloon Flow-limiting Dissection and Residual Stenosis When Angiography is Inconclusive
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Secondary ID [1]
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C1706
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Universal Trial Number (UTN)
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Trial acronym
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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
Diagnosis / Prognosis - Duplex Ultrasound (DUS)
Diagnosis / Prognosis - IVUS with Intraarterial pressure measurement (IAP) if needed
Experimental: Duplex Ultrasound (DUS) - Standard angiography and DUS are performed on the same patients (paired data)
Experimental: IVUS with Intraarterial pressure measurement (IAP) - Standard angiography and Intra-Vascular Ultrasound (IVUS) with Intraarterial pressure measurement (IAP) are performed on the same patients (paired data)
Diagnosis / Prognosis: Duplex Ultrasound (DUS)
Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Duplex Ultrasound
Diagnosis / Prognosis: IVUS with Intraarterial pressure measurement (IAP) if needed
Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Intra-vascular ultrasound associated to Intraarterial pressure measurement if needed
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Intervention code [1]
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Diagnosis / Prognosis
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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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diagnostic accuracy of duplex ultrasound
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Assessment method [1]
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specificity and sensitivity of duplex ultrasound combined to angiography vs angiography alone
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Timepoint [1]
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during index procedure
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Secondary outcome [1]
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diagnostic accuracy of intraarterial pressure measurement
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Assessment method [1]
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specificity and sensitivity of intraarterial pressure measurement combined to angiography vs angiography alone
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Timepoint [1]
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during index procedure
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Secondary outcome [2]
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diagnostic accuracy of intraarterial pressure measurement with IVUS
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Assessment method [2]
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specificity and sensitivity of intraarterial pressure measurement with IVUS combined to angiography vs angiography alone
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Timepoint [2]
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during index procedure
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Secondary outcome [3]
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Target lesion stenting rate
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Assessment method [3]
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Timepoint [3]
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during index procedure
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Secondary outcome [4]
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Number of stents used per target lesion
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Assessment method [4]
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Timepoint [4]
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during index procedure
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Secondary outcome [5]
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Average stent length per target lesion
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Assessment method [5]
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Timepoint [5]
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during index procedure
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Secondary outcome [6]
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Average target lesion length stented (full, spot)
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Assessment method [6]
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Timepoint [6]
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during index procedure
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Secondary outcome [7]
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DCB technical success
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Assessment method [7]
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Delivery and successful use of Passeo-18 Lux DCB to the target lesion to achieve a residual stenosis no greater than 30% in the absence of flow-limiting dissection
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Timepoint [7]
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during index procedure
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Secondary outcome [8]
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Stent technical success
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Assessment method [8]
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delivery and successful use of Pulsar-18 to the target lesion to achieve a residual stenosis no greater than 30%
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Timepoint [8]
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during index procedure
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Secondary outcome [9]
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Procedural success
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Assessment method [9]
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technical success and no MAEs before discharge
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Timepoint [9]
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during index procedure
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Secondary outcome [10]
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Primary Patency
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Assessment method [10]
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Primary patency is defined as DUS peak systolic velocity ratio (PSVR) =2.5 at the target lesion, in the absence of clinically driven Target Lesion Revascularization (cd TLR).
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Timepoint [10]
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1, 6 and 12 months post index procedure
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Secondary outcome [11]
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Major Adverse Event (MAE)
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Assessment method [11]
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Major adverse event (MAE) is defined as device or procedure related death within 30 days post index procedure, major target limb amputation or cd TLR post index procedure
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Timepoint [11]
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1, 6 and 12 months post index procedure
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Secondary outcome [12]
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Major Adverse Cardiac Event (MACE)
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Assessment method [12]
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Major adverse Cardiac event (MACE) is defined as death all causes, myocardial infarction, stroke, death or major amputation
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Timepoint [12]
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1, 6 and 12 months post index procedure
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Secondary outcome [13]
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Major Adverse Limb Event (MALE)
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Assessment method [13]
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Major adverse limb event (MALE) is defined as severe limb ischemia leading to an intervention or major vascular amputation
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Timepoint [13]
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1, 6 and 12 months post index procedure
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Secondary outcome [14]
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Clinically driven Target Lesion Revascularization
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Assessment method [14]
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Clinical Event Committee adjudicated TLR =Any post index procedure surgical or percutaneous intervention to the target lesion plus 5 mm proximal and distal to the stented lesion edge when a stent is used
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Timepoint [14]
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1, 6, 12, 24 and 36 months post index procedure
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Secondary outcome [15]
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Major target limb amputation rate
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Assessment method [15]
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Timepoint [15]
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1, 6, 12, 24 and 36 months post index procedure
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Secondary outcome [16]
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all cause of death rate
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Assessment method [16]
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Timepoint [16]
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1, 6, 12, 24 and 36 months post index procedure
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Secondary outcome [17]
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Hemodynamic improvement
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Assessment method [17]
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change in Ankel Brachial Index at 1, 6 and 12 months post index procedure compared to baseline
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Timepoint [17]
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1, 6 and 12 months post index procedure
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Secondary outcome [18]
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Rate of primary sustained clinical improvement
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Assessment method [18]
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Improvement in Rutherford Classification of at least one category for claudicants and by wound-healing and resting pain resolution for critical limb ischemia as compared to pre-procedure without the need for repeat TLR
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Timepoint [18]
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1, 6 and 12 months post index procedure
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Secondary outcome [19]
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Rate of secondary sustained clinical improvement
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Assessment method [19]
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Improvement in Rutherford Classification of at least one category for claudicants and by wound-healing and resting pain resolution for critical limb ischemia as compared to pre-procedure including the need for repeat TLR
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Timepoint [19]
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1, 6 and 12 months post index procedure
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Secondary outcome [20]
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Health Related Quality of Life
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Assessment method [20]
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The Euroquol Group 5 dimension quality of life questionnaire (EQ-5D) is a descriptive system comprising 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The results in a 1-digit number expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes patient's health state.
The EQ Visual Analogue Scale records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement
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Timepoint [20]
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baseline, 1, 6 and 12 months post index procedure
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Secondary outcome [21]
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Walk Impairment
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Assessment method [21]
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The Walk Impairment Questionnaire (WIQ) measure measures self-reported walking distance, walking speed, and stair-climbing ability
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Timepoint [21]
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baseline, 1, 6 and 12 months post index procedure
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Secondary outcome [22]
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Resource utilisation
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Assessment method [22]
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Costs will be evaluated using specific information on resource use
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Timepoint [22]
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during index procedure, 12 month
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Eligibility
Key inclusion criteria
- Subject has provided written informed consent before any study specific test or
procedure and is willing and able to comply with the required follow-up visits and
procedures
- Subject has a chronic, symptomatic lower limb ischemia defined as Rutherford
categories 2 to 4
Angiographic criteria:
- Single lesion or consecutive single lesions with a healthy segment(s) of = 2cm
in-between
- De novo, restenotic or (re)occluded lesion(s) post Percutaneous Transluminal
Angioplasty in the native superficial femoral artery (SFA) and or the proximal
popliteal artery (PPA)
- Lesion(s) must be located at least 1 cm distal to the profunda femoris artery and at
least 3 cm above the knee joint (radiographic joint space)
- Degree of stenosis =70% by visual angiographic assessment
- Vessel diameter = 4 and = 7 mm
- Patent inflow artery, free from significant lesion (>50%) as confirmed by angiography.
Treatment of the target lesion is acceptable after successful treatment of inflow
iliac and/or common femoral artery lesion. The inflow lesion cannot be treated with a
DCB or a Drug Eluting Stent
- Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with
at least one of the three vessels patent (<50% stenosis) to the ankle or foot with no
planned intervention
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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
- Previously stented target lesion
- Target lesion/ previously treated with drug-coated balloon <12 months prior to
enrollment.
- Use of atherectomy, laser or other debulking devices in the target SFA/PPA vessel
during the index procedure.
- Failure to cross the target lesion with the guide wire
- Presence of a complication following pre-dilation of target lesion, which in the
opinion of the investigator would not allow the procedure to be performed in
accordance with the REACT approach
- Presence of aneurysm in the target vessel.
- Prior on planned major amputation (above the ankle) in the target limb
- Acute ischemia and/or acute thrombosis of the target SFA/PPA vessel prior to
enrollment.
- Perforation of the target vessel as evidenced by extravasation of contrast media prior
to enrollment
- Known hypersensitivity or contraindication to contrast media that, in the opinion of
the investigator, cannot be adequately pre-medicated
- Known hypersensitivity/allergy to Paclitaxel or other components of the
investigational devices and comparator (e.g., nitinol, amorphous silicon carbide,
polymer)
- Known hypersensitivity or contraindication to antiplatelet, anticoagulant,
thrombolytic medications that would be administered during the study
- Subject with uncorrected bleeding disorders
- Subject with renal failure
- Life expectancy less than 12 months due to other comorbidities, that in the
investigators opinion, could limit subject ability to comply with the study required
follow-up visits/procedure and threaten the study scientific integrity
- Pregnant, breast feeding, or plan to become pregnant in the next 12 months.
- Current participation in another investigational drug or device clinical study that
has not completed the primary endpoint at the time of enrollment or that upon
investigator judgment could clinically interferes with the current study endpoints
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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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
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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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
9/11/2018
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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
1/03/2024
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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6000 - Perth
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Graz
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Country [2]
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Austria
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State/province [2]
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Vienna
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Country [3]
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Belgium
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State/province [3]
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Aalst
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Country [4]
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Belgium
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State/province [4]
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Dendermonde
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Country [5]
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Belgium
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State/province [5]
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Kortrijk
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Country [6]
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France
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State/province [6]
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Nantes
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Country [7]
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France
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State/province [7]
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Paris
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Country [8]
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Germany
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State/province [8]
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Arnsberg
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Country [9]
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Germany
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State/province [9]
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Bad Krozingen
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Country [10]
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Germany
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State/province [10]
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Biederbach Baden-Wurttemberg
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Country [11]
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Germany
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State/province [11]
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Leipzig
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Country [12]
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Germany
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State/province [12]
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Tübingen
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Country [13]
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Germany
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State/province [13]
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Weinheim
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Country [14]
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Spain
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State/province [14]
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Guadalajara
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Biotronik AG
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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
Both drug-coated balloon and stents have been used for a number of years to treat subjects
with Peripheral Artery Disease (PAD) and are recognized as very good treatment methods.
However, due to a higher risk of blood clot formation, requiring a longer anticoagulant
treatment, and the challenge of treating re growth of tissue extending through the metal mesh
of the stent, the physicians try to reserve stent placement to situation where it's really
needed, in case of flow-limiting vessel dissection or acute re-narrowing.
The purpose of this study is to evaluate the utility of several procedural diagnostic
techniques in helping the physicians to better decide whether a stent is needed or not.
The study will also estimate the safety and efficacy of Passeo-18 Lux drug-coated balloon
associated to Pulsar 18 bare metal stent when and where needed to treat PAD
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03547986
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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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Koen Deloose, MD
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Address
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Sint Blasius Hospital 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/NCT03547986
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