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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/NCT02471638
Registration number
NCT02471638
Ethics application status
Date submitted
11/06/2015
Date registered
15/06/2015
Date last updated
26/06/2019
Titles & IDs
Public title
DETOUR I Clinical Study
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Scientific title
PQ Bypass Systems for Femoropopliteal Bypass II (PQB 4 FP II)
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Secondary ID [1]
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STP 115
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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
Treatment: Devices - PQ Bypass System for Femoropopliteal Bypass
Experimental: Single arm study - PQ Bypass System for Femoropopliteal Bypass to complete percutaneous fem-pop bypass
Treatment: Devices: PQ Bypass System for Femoropopliteal Bypass
To access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
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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 Performance Endpoint (Rate of primary patency)
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Assessment method [1]
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Rate of primary patency. Primary patency defined as: no evidence of clinically significant stenosis (=50%) within the stent graft or immediately above or below the treated arterial segment based on duplex ultrasound (systolic velocity ratio of >2.5).
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Timepoint [1]
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6 months
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Eligibility
Key inclusion criteria
- Willing and able to provide informed consent
- Age 18 or older
- Rutherford Classification of 3-5
- Patent iliac and femoral arteries/veins and access vessels, of sufficient size and
morphology (including tortuosity), to allow endovascular access with 8 Fr. introducer
sheath
- Femoro-popliteal lesions =10 cm in length considered to be:
- Chronic total occlusion (100% stenosis)
- Diffuse stenosis (>50% stenosis) with moderate to heavy calcification
- In-stent restenosis (>50% stenosis)
- Proximal and distal target vessels are 5.4-7.0 mm in diameter
- Orifice and proximal 1 cm of SFA is patent
- Patent popliteal artery 3 cm proximal to tibial plateau
- At least 1 patent tibial artery to the foot
- Patent femoral vein = 10 mm in diameter or duplicate femoral vein
- Subject has > one year life expectancy
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Minimum age
18
Years
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Maximum age
90
Years
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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
- Bypass length required > 30 cm
- History of deep vein thrombosis
- Has a known hypersensitivities, allergies or contraindications to: nitinol, PTFE;
aspirin, heparin, antiplatelet, anticoagulant or thrombolytic therapy; or
anticoagulation or contrast media that is not amenable to pre-treatment;
- Has a known history of intracranial bleeding or aneurysm, myocardial infarction or
stroke within the last 12 months
- Pregnant or nursing
- Untreated flow-limiting aortoiliac occlusive disease
- Has renal failure (eGFR < 30mL/min)
- Major distal amputation (above the transmetatarsal) in the study or non-study limb
- Patient has had a revascularization procedure on the target limb within 30 days
- Patient has a planned amputation of the target limb
- Previous bypass surgery on the target limb
- Patient is participating in another clinical study for which follow-up is currently on
going.
- Patient has a condition that in the view of the investigator precludes participation
in this study
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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
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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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
1/01/2015
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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
1/09/2020
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Actual
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Sample size
Target
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Accrual to date
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Final
78
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Chile
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State/province [1]
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Santiago
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Germany
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Leipzig
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Italy
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State/province [3]
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Milan
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Latvia
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State/province [4]
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Riga
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New Zealand
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State/province [5]
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Auckland
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Poland
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State/province [6]
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Gdansk
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Country [7]
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Poland
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State/province [7]
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Poznan
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Poland
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State/province [8]
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Warsaw
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
PQ Bypass, Inc.
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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
To assess the safety and performance of the PQ Bypass System to access, deliver guidewires
and implant stent grafts for a percutaneous fem-pop bypass.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02471638
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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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Address
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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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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/NCT02471638
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