Back to resultsPQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass (PQB4FP1)
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
PQ Bypass Guide Wire Delivery System
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
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
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
Sites / Locations
- Auckland City Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PQ Bypass Guide Wire Delivery System
Arm Description
PQ Bypass Guide Wire Delivery System to complete percutaneous Fem-pop bypass
Outcomes
Primary Outcome Measures
Primary Patency
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01930071
Brief Title
PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass
Acronym
PQB4FP1
Official Title
PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PQ Bypass, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PQ Bypass Guide Wire Delivery System
Arm Type
Experimental
Arm Description
PQ Bypass Guide Wire Delivery System to complete percutaneous Fem-pop bypass
Intervention Type
Device
Intervention Name(s)
PQ Bypass Guide Wire Delivery System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Patency
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Holden, MD
Organizational Affiliation
Auckland City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass
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