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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01930071




Registration number
NCT01930071
Ethics application status
Date submitted
20/08/2013
Date registered
28/08/2013
Date last updated
13/04/2017

Titles & IDs
Public title
PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass
Scientific title
PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass
Secondary ID [1] 0 0
STP 114
Universal Trial Number (UTN)
Trial acronym
PQB4FP1
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 Guide Wire Delivery System

Experimental: PQ Bypass Guide Wire Delivery System - PQ Bypass Guide Wire Delivery System to complete percutaneous Fem-pop bypass


Treatment: Devices: PQ Bypass Guide Wire Delivery System
The PQ Bypass Guide Wire Delivery System is used to bypass lesions in the peripheral vasculature percutaneously. A guidewire is placed from the artery proximal to the lesion to the artery distal to the lesion using the vein as a conduit with the Guidewire Delivery System. Once in place, commercially available stent grafts will be placed to complete the bypass.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Patency
Timepoint [1] 0 0
30 days

Eligibility
Key inclusion criteria
- Willing and able to provide informed consent

- Age 18 or older

- Rutherford Classification of 3-5

- Lesions =10cm 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 4.8 - 7.5 mm in diameter

- Orifice and proximal 1cm of SFA is patent

- Patent popliteal artery 3cm proximal to tibial plateau

- At least 1 patent tibial artery to the foot

- Patent femoral vein
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of deep vein thrombosis

- Has a known sensitivity or allergy to contrast materials that cannot be adequately
pre-treated

- Has a known sensitivity or allergy to aspirin, heparin or anti-platelet medications

- Documented in-sensitivity to anti-platelet medication

- Has a known or previous coagulopathy

- Pregnant or lactating

- Untreated flow-limiting aortoiliac occlusive disease

- Has renal failure (GFR < 30mL/min)

- Major distal amputation (above the transmetatarsal) in the study or non-study limb

- Patient has had a procedure on the target limb within 30 days

- Previous bypass surgery on the target limb

- Bypass length required is greater than 35cm

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
Completed
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
New Zealand
State/province [1] 0 0
Auckland

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 of performing a percutaneous fem-pop bypass using the PQ Bypass
Guidewire Delivery System and commercially available stent grafts.
Trial website
https://clinicaltrials.gov/show/NCT01930071
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Holden, MD
Address 0 0
Auckland City Hospital
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