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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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) - 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).
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
Gender
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
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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.
Trial website
https://clinicaltrials.gov/show/NCT02471638
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

Summary results
Other publications