Peripheral Arterial DiseasePQB4FP1NCT01930071
PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass
A study testing PQ Bypass Guide Wire Delivery System in people with Peripheral Arterial Disease, run by Endologix at 1 site in New Zealand.
Trial summary
To assess the safety of performing a percutaneous fem-pop bypass using the PQ Bypass Guidewire Delivery System and commercially available stent grafts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- PQ Bypass Guide Wire Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteNew Zealand
- Study dates
- Nov 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
To assess the safety of performing a percutaneous fem-pop bypass using the PQ Bypass Guidewire Delivery System and commercially available stent grafts.
Read the detailed description
Multi-center, single-arm first-in-man study utilizing the PQ Bypass Guide Wire Delivery System to access, deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.
- Conditions
- Peripheral Arterial Disease
- Being tested
- PQ Bypass Guide Wire Delivery System
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PQ Bypass Guide Wire Delivery SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PQ Bypass Guide Wire Delivery System | Experimental | PQ Bypass Guide Wire Delivery System to complete percutaneous Fem-pop bypass Receives: Device: PQ Bypass Guide Wire Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Holden, MD, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930071
- Sponsor's protocol ID
- STP 114
- Acronym
- PQB4FP1
- Status last verified
- Feb 2024
- First submitted
- 20 Aug 2013
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass
- ClinicalTrials.gov ID
- NCT01930071
- Acronym / sponsor ID
- PQB4FP1 / STP 114
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety of performing a percutaneous fem-pop bypass using the PQ Bypass Guidewire Delivery System and commercially available stent grafts.
Detailed description
Multi-center, single-arm first-in-man study utilizing the PQ Bypass Guide Wire Delivery System to access, deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PQ Bypass Guide Wire Delivery System | Experimental | Device: PQ Bypass Guide Wire Delivery SystemPQ Bypass Guide Wire Delivery System to complete percutaneous Fem-pop bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Willing and able to provide informed consent
- Age 18 or older
- Rutherford Classification of 3-5
- Lesions ≥10cm in length considered to be:
- Proximal and distal target vessels are 4.8 - 7.5 mm in diameter
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PQ Bypass Guide Wire Delivery SystemThe 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. | Device | PQ Bypass Guide Wire Delivery System |
Primary outcome
Primary Patency
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Holden, MD principal investigator
Auckland City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PQ Bypass Guide Wire Delivery System in people with Peripheral Arterial Disease, run by Endologix at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.