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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/NCT01930071




Registration number
NCT01930071
Ethics application status
Date submitted
20/08/2013
Date registered
28/08/2013
Date last updated
1/03/2024

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
Sex
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
N/A
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
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
4
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
Endologix
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01930071