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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02471638




Registration number
NCT02471638
Ethics application status
Date submitted
11/06/2015
Date registered
15/06/2015

Titles & IDs
Public title
DETOUR I Clinical Study
Scientific title
PQ Bypass Systems for Femoropopliteal Bypass II (PQB 4 FP II)
Secondary ID [1] 0 0
STP 115
Universal Trial Number (UTN)
Trial acronym
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 - 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Performance Endpoint (Rate of primary patency)
Timepoint [1] 0 0
6 months

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
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2020
Actual
Sample size
Target
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Chile
State/province [1] 0 0
Santiago
Country [2] 0 0
Germany
State/province [2] 0 0
Leipzig
Country [3] 0 0
Italy
State/province [3] 0 0
Milan
Country [4] 0 0
Latvia
State/province [4] 0 0
Riga
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
Poland
State/province [6] 0 0
Gdansk
Country [7] 0 0
Poland
State/province [7] 0 0
Poznan
Country [8] 0 0
Poland
State/province [8] 0 0
Warsaw

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
PQ Bypass, Inc.
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)?
No
No/undecided IPD sharing reason/comment


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/NCT02471638