PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass

Peripheral Arterial Disease Clinical Trial

— PQB4FP1  

Official title:

PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930071
• Other study ID #: STP 114
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: June 2015

Study information

• Verified date: February 2024
• Source: Endologix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
New Zealand	Auckland City Hospital	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Endologix

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Patency		30 days